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Mona Reeder / Dallas Morning News
Whitney Mitchell, 20, of Dallas, lost her arms and legs nearly two years ago to a fast-moving bloodstream infection called sepsis. A new device just approved by the Food and Drug Administration is the first to allow rapid identification of specific bacteria that cause the infections.
Nearly two years after her teenage daughter lost all four limbs to a dangerous bloodstream infection, Patricia Kirven is stunned at how little most people know about sepsis.
“You can ask the average person on the street and they don’t know what it is,” said Kirven, mother of Whitney Mitchell, now 20. “I have a friend who says that sepsis is the killer you’ve never heard of.”
Only high-profile cases seem to attract attention, like Whitney Mitchell's disfiguring infection, or the recent death of a 12-year-old New York boy, Rory Staunton, who developed severe septic shock two days after a minor gym class cut.
That’s despite the fact that hospital stays for sepsis in the U.S. have more than doubled in recent years, accounting for about 1.6 million hospitalizations a year and requiring treatment for some 4,600 new patients every day, according to a 2011 report from the Agency for Healthcare Research and Quality.
The infection -- also known as septicemia or bacteremia -- can be sudden, capricious and difficult to identify, masquerading as a minor injury or illness that erupts into full-blown, whole-body organ failure within hours or days.
The mortality rate is alarming -- between 20 percent and 50 percent -- and largely depends on how quickly victims are diagnosed and treated with powerful antibiotics to battle the bacteria racing through their systems. Among those who live, amputations are common after the infection leads to tissue death in the limbs.
In Whitney Mitchell’s case, a lawsuit accuses doctors at the Medical City Dallas Hospital of not giving her appropriate antibiotics for 38 hours after she showed up in the emergency room. In Rory Staunton’s case, his parents told the New York Times that critical medical information was ignored at NYU Langone Medical Center and that the signs of sepsis were disregarded. In both cases, critics said the victims were sent home from the emergency room before returning a day or so later in life-threatening condition.
“Getting a quick answer is a matter of life and death,” said Preeti Pancholi, an assistant professor of pathology and director of clinical microbiology at The Ohio State University Medical Center.
That’s why her hospital recently joined with five others across the country to test a device approved in June by the federal Food and Drug Administration that experts believe could drastically change the way sepsis infections are detected and managed.
About the size of a small microwave oven, the Verigene Gram-positive Blood Culture Nucleic Acid Test is the first system approved by the FDA to identify quickly certain bacteria responsible for bloodstream infections -- and whether some are resistant to the top drugs used against them.
Instead of the three days required for a traditional blood culture panel, results from the Verigene test come back within three hours, identifying up to a dozen specific bacteria known to cause sepsis, including strains of Staphylococcus, Streptococcus, Enterococcus and Listeria.
Plus, the test can tell whether the germs are Methicillin-resistant Staph aureus, or MRSA, or vancomycin-resistant Enterococci, or VRE, two of the toughest pathogens around.
“That’s a big change,” said Nathan Ledeboer, medical director of the clinical microbiology and molecular diagnostics laboratories at the Medical College of Wisconsin. “We don’t have to wait three days any more to get appropriate antibiotics on board.”
Ledeboer, like Pancholi, agreed to participate in a seven-month clinical trial of the device produced and manufactured by Nanosphere Inc., of Northbrook, Ill.
Two weeks ago, Ledeboer, who said he has no financial ties to the product, went live with the Verigene test.
“In those two weeks, we’re seeing that patients are in fact being treated more appropriately sooner,” he said.
The reason is this: When patients come in with signs of suspected sepsis, including fever, low blood pressure and a racing heartbeat, it can be difficult for doctors to be certain it's a bloodstream infection and not another problem. Once they do confirm sepsis, doctors need to treat the patients fast. A 2010 study in the journal Critical Care Medicine found that for every hour of delay in administering antibiotics, mortality rose by 7.6 percent.
To that end, they break out what Ledeboer calls the “big guns” of antibiotics, the broad-spectrum drugs that can treat many pathogens at once. The trouble is, many bacteria are becoming resistant to antibiotics, meaning the treatments would be either be useless against the infections -- or they’ll help create the next generation of even tougher bugs.
“What we’re seeing now is that if you present with sepsis or any Gram-negative infection in New York City, you run a 30 percent risk of a pan-resistant organism,” Ledeboer said.
That is, an infection that virtually can’t be cured.
With the Verigene test, quick results mean doctors know faster exactly which bacteria they’re up against -- and whether the bugs are already resistant to top drugs.
“It means patients are going to get out of the hospital faster, out of the ICU faster and it increases their chances of surviving sepsis,” Ledeboer said.
The test works by mapping the genome of a particular bacterium and capturing it on a glass slide, said Bill Moffitt, president and chief executive of Nanosphere. If that bacterium is present in the blood sample, it will bind to the material on the slide. Then the test uses silver-coated gold nanoparticles to bind to the captured genetic sequence. When light is shined on the slide, if the spots light up, it means the bug is present in the sample.
In trials that compared the Verigene test to traditional cultures and then verified them at an independent laboratory, the new device had a very high rate of accuracy, at least above 95 percent said Pancholi.
FDA officials based their approval decision on a study of 1,642 patient blood samples that compared traditional methods with the Vergiene test, with accuracy ranging from 93 percent to 100 percent.
Since the FDA approval, more than 200 hospitals have expressed interest, Moffitt said. The Verigene units cost between $50,000 and $100,000 apiece. The test panels cost about $75 each.
But Moffitt and Ledeboer estimate that the tests could significantly reduce the current $20,000 cost of a single sepsis workup.
Independent infectious disease experts were quick to praise the new technology.
“This seems to be the first product from our molecular revolution,” said Dr. William Schaffner, chair of the department of preventive medicine at Vanderbilt University. Quicker detection and treatment of sepsis may be the only way to start to cut the rising mortality caused by the insidious bacteria, he added.
“It’s a very exciting development," he said.
For victims already ravaged by sepsis, such progress is bittersweet. If there had been a quicker test to identify specific bacteria, perhaps doctors would have identified the source of Whitney Mitchell's infection, said Kervin, her mother.
"They never could tell us exactly what it was," she said.
Reached by phone at the Dallas home she shares with her mom, Whitney Mitchell said she was hospitalized for months after her amputations in 2010. She now spends her days going to physical therapy sessions, doing exercises at home to strengthen her shortened limbs and trying as best she can to resume her life. She's got a lively online presence and a supportive community. Although she has prostheses for her arms, including one set she calls her "pretty hands," she said she's gotten good at typing using a tough nub on her residual arm.
"I'm always on the computer," said Mitchell. "I have a callus on the tip of it because I type so much."
Bob Bergert, the lawyer representing Medical City Dallas Hospital and the medical team involved said that they have "great empathy" for Mitchell and her family, but added that she received "appropriate care based on the facts and resources available to the healthcare providers."
Still, at age 20, Whitney Mitchell faces a lifetime of prosthetics and several additional surgeries. Kervin said she wishes there had been a test, a tool, anything that would have stopped the infection that raced through her daughter's body.
“It makes me happy and sad,” Kervin said. “Sad that it wasn’t there for my daughter, but glad that it will help other families from going through the pain we’re going through.”
More from Vitals:
- Gym class cut leads to deadly infection in boy, 12
- Burned-out nurses linked to more infections
- Deadly MRSA infections on the decline
This past spring, Rory Staunton, 12, got a minor scrape on his arm during gym class. Four days later, he died of toxic shock syndrome. TODAY's Savannah Guthrie reports and speaks with Rory's parents, Orlaith and Ciaran Staunton, who say doctors could have done more to save him.
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Am I the only person who wonders why there are now all these highly toxic bacteria strains? It used to be that there was the occasional staph infection that people either contracted in a hospital or from some odd place, and occasionally people died from it - now there are flesh eating bacteria and horrendous infections that people are losing limbs to or dying from. Where did they come from?
There has always been sepsis and other flesh-eating bacteria. The only thing that has changed is how we have access to all of the reports of this, thru the news, internet, etc.
THIS IS A VERY BIG DEAL!!!
As an ICU physician, one of the things we fear most is the hospitalized patient (particularly in the ICU) with multiple intravenous lines, "deep" intravenous "central" lines, repirators and breathing (endotracheal-tracheostomy), urinary catheters, etc.
Each is an "invasion" with a "foreign object" just waiting to get infected, often by multiply resistant bacteria (and where did they come from - overuse of broad spectrum antibiotics in humans and animals (feed lots, hen houses, etc.)
When one suspects an infection (and in this case "sepsis", a blood-borne infection) you are racing the clock. Traditionally, one takes "cultures" (swabs, blood samples, sputum samples, urine specimens) and 1. examines them under a microscope (a Gram stain) to get a gross idea of what is there, and puts them in culture medium (liquid, an agar culture plate) and incubates them. This can take hours (for a heavily infected sample, to days or even weeks (TB). Having done that, one can find out what antibiotics the bacteria is sensitive to.
In the mean time, one starts "empiric" antibiotic therapy with one of more antibiotics , hoping you have covered the right bacteria. It is an intelligent "guess", aided by the results in previous cultures and sensitivities (this is done by the lab and the Infectious Disease surveillance nurse).
If you guess right - great. If you guess wrong, the patient gets sicker until the sensitivities come back.
The addition of such immediate screening can save hours, if not days, of time and expense of being in the hospital and getting people home alive.
Like any device, there are errors - in this case, the machine is 95% right, leaving 5% wrong (grossly oversimplified).
In any case, the potential cost-benefit ratio (cost of the machine vs the reduction in the cost of hospitalization could be huge. Is it REALLY true? THAT is why all devices and treatments undergo (hopefully) randomized clinical trials to see if the claims are true or not.
Poorly researched articles lead to poor understanding. Sepsis is a syndrome caused by an infection. The infective agent can be bacteria or fungus. Septicemia or bactremia are terms for bacteremia in the blood. If one doesn't consider fungus as a causative agent a person cannot have sepsis without bacteremia but one can have bacteremia without sepsis.
Sepsis is a clinical diagnosis. That means that diagnosing sepsis takes a short time and all you need to diagnose it is a thermometer, a watch and a blood pressure cuff. Put shortly, sepsis is the Systemic Inflammatory Response Syndrome (SIRS) that is caused by an infection. High pulse, high rate of breathing, high or low temperature. If the blood pressure starts to drop the person is progressing to shock. The syndrome can be caused by any number of things but doctors are trained to treat it as Sepsis from the very first second they see it. The person gets a lot of iv fluid to maintain blood pressure and sink the heart rate. They get oxygen to make sure the breathing is as effective as possible. Blood is drawn immediately before administering antibiotics and sent to the lab where they try to grow the bacteria that is causing it. (The growing takes at least a day sometimes more.) The antibiotics that are used are what's called empiric treatment and is based upon the most likely bacteria at the most likely source. That is to say if the sepsis started as a cut maybe Staphylococcus is most likely. However, broad-spectrum antibiotics cover several different scenarios. When the bacteria grows in the blood then the doctor can change the treatment if necessary.
Some bacteria create toxins. These toxins are on the inside of the bacteria. If a bacteria looks like a little balloon, then one can imagine that when it dies it pops. Then the toxins can leak out. The only way of getting rid of a bacterial infection is making the bacteria dead. Our own immune systems as well as the antibiotics we use can, in some cases, make the problem worse by releasing toxins that make Sepsis worse.
As for the unclear $20,000 Sepsis workup, someone is getting ripped off. Thermometer, watch, blood pressure cuff.
A Friend of ours passed away last wednesday from this infection.
I blame society, based on the fact that our health care system is pumping tons of antibiotics into our bodies . when you do that the immune system relies on these miracle pills to do the job our bodies should be doing naturally. this also allows these bad bugs to create an immunity themselves from the Anti biotics.
Thanks docs, but you still haven't explained, in CLEAR English, why all of a sudden this is happening. As kids, we grew up with scrapes and cuts from outside playing every day! Why now?
Troy -
There are actually many answers to that (and my colleagues will no doubt correct me).
There is nothing more instructive than walking through an old New England graveyard and looking at the number of small child-sized gravestones, or the mothers that died in childbirth.
In "modern" times
1. This is NOT all of sudden happening. This has been an increasing trend over the past 20-30 years.
2. People live much longer now. As we age, our bodies are less able to repair themselves (one of those systems being the immune system which fights infection).
3. To keep people alive, we are much more "invasive" than we used to be. Some of this is truly justified, some is "we do because we can" and it makes no difference in "quality of life". (Personal note - as I am now "older" some of my good and old friends are starting to die - there is such a thing as "self-determination" and "death with dignity".
4. In AHRQ's study (Agency for Healthcare Research & Quality) by far the highest group for this are Medicare patients. Why? Because they are over 65 and by that measure alone (age and multiple diagnoses) are more at risk.
5. We have more antibiotics. Please remember, the first two truly effective antibiotics weresulfa compounds (circa 1930) and penicillin (circa 1940). Before that, there were compounds like arsenic and mercury for syphilis (however - toxicity grossly outweighed the benefits...)
6. The "bugs" (bacteria) are smarter than us. Over time, more classes of antibiotics have been discovered to treat infections that became resistant to older treatments (yes, in WW2, gonorrhea was treatable with simple penicillin). These bugs - the ones you would have picked up in a scrape have replaced the previously less-aggressive bacteria.
7. Indiscriminate overuse of broad-spectrum antibiotics leads to more resistant bacteria (such a Multiply Resistant Staphylococcus Aureus - MRSA). This has happened in humans and the massive amounts of antibiotics fed to animals to make them gain weight faster, especially in feed lots, chicken houses, etc. All this does is increase the mutation rate of bacteria to survive the antibiotic.
8. Given enough time, bacteria "forget". Many bacteria which had become resistant to older antibiotics are sensitive again. Why? Because there was no longer an "pressure" against them. As the "resistance" to older antibiotics was no long a survival factor, there was no reason to select for this gene anymore.
I hope this was plain English enough... This is how I try to explain this to patients, but it requies a bit of concentration.
At last, some intellegent discussions about a real issue. I for one am so happy to see this. Some times I get to the first or second of these "discussions" and just quit when it is all politics and blame. This is great and real. I always knew Americans were smarter than the discussions lead some to believe. And bacteria, fungus, and spores have been found in the oldest excavations. Just didn't have the ability to track or talk about them.
Of course they couldn't tell them exactly what it was, most of the time the medical field is treating patients on experience and not on test results. Sure for the large medical conditions they have test results. But you show up with some sorta flu like symptoms.. you don't get any test. You get the doctors experience and maybe a typical shot of anitbiotics or more likely a prescription. You can only hope you never are the exception to the experience, because if you are you have a snowballs chance in hell of getting the proper treatment.
I can relate. We lost our middle daughter to GAS - Group A Strep being in the blood stream. Within 48 hours it had attacked every major organ in her body. She was only 6 1/2. Miss her every minute of every day but we made a little lemonade by opening a cupcake shop in her honor. It was a dream of hers to own and operate a bakery.
Probably sepsis is becoming so much more prevalent because of the overuse of hand sanitisers and wipes. They kill natural bacteria on the skin and provide opportunity for the invasion of bad bacteria and viruses. All that is needed is a good hand wash.
I am sorry for those kids since they died and were disfigured needlessly. For the rest of you some advice, if you get a good cut or scrape clean it out with water and treat it with hydogen peroxide, very cheap very effective and always works. Bugs may become resistant to synthetic antibiotics but most bugs cannot withstand the oxidizing effects of h202 (hydrogen peroxide). That said I would also suggest looking at natural anitbiotics, one that has worked extremely well for septic ulcers is Manuka honey, it has very complex natural antibiotic constituents which cannot be replicated in a lab and which bugs have no immunity too, worth a try yeh, just saying. Just pour it on, that easy.
And it goes well with biscuits, too! Actually, most marketed antibiotics are natural based.
The meek shall inherit the earth.
Of course you all thought that meant the human underprivileged, the downtrodden, the poor.
No indeed. It means bacterium and cockroaches (bed bugs more likely).
Soon we will not be able to fight off these infections.
Could the Tea Partiers be right... we should just let the sick and elderly die like we did when we lived in caves?
(You know... just make grandma sleep outside the cave at night where she just dissappears by morning and won't be a burden to the tribe any more. It could save the species. Not sure we'd deserve to live then. Won't be my call, I'll be gone before it gets that bad. But if we keep going the way we are, I can see someone making that call. Rubio? Ryan? NO... Cristie is too, well, he'll be gone too.)
Of course the Tea Party is right! This country should be a for-profit corporation. It should be run by businessmen. That's right! Only millionaires should have access to any benefits. If you're some loser making only 60 grand a year, get the hell out of here, you're just a parasite on the profit-makers' system.
Unfortunately, most self-proclaimed Tea Partiers are fat white old and stupid, so they have no idea this is the scenario they support.
Actually the Tea Party largely supports smaller government and more free market principles. You are confusing crony capitalism with capitalism, they are far from the same thing. The Tea Party supports equal opportunity, not equal results which you progressives want to do. It's kind of like the kid crying and not letting anyone else play his video games just because his friends beat him at them. Kind of childish if you ask me. Good thing Obamacare will further tax medical device companies like the one in the article that create innovative new solutions to problems. Now less people will want to bring about solutions to our medical problems.
One year ago my wife had sepsis. The first signs were confusion and generalized pain. She was not willing to go to the hospital with me. My first 911 call brought a sheriff and the fire department paramedics. The sheriff sided with my wife that she didn't have to go to the hospital. Four hours later my second call brought out aggressive fire department paramedics and the accompanying sheriff did not interfere. At the Thousand Oaks CA hospital emergency ward she was diagnosed with a bladder infection and given a room. An hour later her temperature started to rise. The next day she was diagnosed with a kidney infection. The following day she was diagnosed with sepsis and a kidney infection. She spent two weeks in the hospital constantly getting antibiotics with a drip. The kidney specialist stopped her lithium pills and said after twenty-five years she could no longer take them as her kidneys could no longer tolerate that medicine. A week after discharge she was in a full blown psychosis due to a low dose of some alternate to lithium. Again I had her sent to the hospital via the fire department and again against her will. After several hours while she was in the emergence room I went home confident she would be admitted. What happened was she was transferred by ambulance to a psychiatric hospital in Pasadena fifty miles away. The real kicker in all this was the Thousand Oaks hospital did not update the records of her being transferred and for four hours I only knew she was missing!!! The psychiatric hospital did not receive any information from the Thousand Oaks hospital as to what was wrong and simply keep her in a locked facility until I showed up and give detailed information. She was then scheduled to receive zyprexa but refused to take the medicine. The next day the psychiatrist called me at home saying she continued to refuse to take the medicine and he would need a court order to force her compliance. This would take a couple of weeks. I told him I was driving to Pasadena and would make her take the pill and then hung up. By the time I got there she had taken the first pill and was sleeping. From that point on she has continued to improve.
Going to the general hospital in Thousand Oaks California is akin to getting a loan from the mafia. Hospitals are not benevolent institutions. Law enforcement was a hindrance in all this. The laws on these matters do not aid the sick. However I give the Fire Department a very big at-a-boy.
RNMike said-- "These are stories of people who weren't treated and waited more than a day for a re-evaluation (they got bad medical advice, sure, but this is not common nor acceptable practice)"
RNMike---I agreed with a lot of what you did post, but with the numerous number of ER visits my Husband endured, he got a LOT........LOT........LOT of BAD medical advice (not at the same hospitals, either!). So, it WAS common for him (sadly enough), but I agree, is NOT an acceptable practice!
Thanks for sharing.
This is welcome technology. We lost our 16 year old daughter to sepsis 8 years ago. Although this would not have helped her, because her condition deteriorated very quickly (within hours of exhibiting flu symptoms,) I am happy for those who have a wider window.
There is one other thing that struck me, however. Although the physicians in the ER were treating Sarah for the wrong condition- meningococcemia, NEVER did it even occur to us to sue the hospital or the physicians involved. In our opinion, they did the best that they could do. Did they miss the mark? Yes. Are they human? Absolutely. We should never expect our physicians to be gods.
I am happy that doctors will have a new diagnostic tool that could save families from our kind of loss and victims from the ravaging that defines what sepsis is.
Lewisville hospital almost killed my husband with their inability to identify necrotizing fasciitis, which is in this family of illnesses. A night nurse claimed it was NF, but a lazy surgeon didn't want to operate. He didn't seem to be in the mood. We had to basically kidnap my husband out of the Lewisville hospital because they didn't want to let him go! They threatened to interfere with his insurance and said we were making him sicker. My advice, any time the hospital staff is acting weird, or like their hiding something, or they seem concerned about your doctor's lack of interest ... run, fast. Thank GOD we got my husband to doctor Ippollito at Dallas Medical Center. Dr. Ippolito started cutting on my husband within the hour and that's why my husband has legs. Dr. Ippolito is our family hero.
Another Shiny example of why Health Care costs are out of control...
$50 too $100 grand for a small unit..
Give me a break...Is it made out of GOLD?????????
The GREEDY are ruining this World?
As JoNel’s article points out, early detection and quick administration of antibiotics and IV fluids are important to improving sepsis survival and reducing complications. Because the symptoms of sepsis are very general, it can be difficult to diagnose sepsis in its early stages. Patient screening criteria, rapid diagnostic testing with assays such as procalcitonin and lactate, and automated alert programs can all be used to help quickly identify sepsis patients. A great example is a recent nine-hospital collaborative in San Francisco that reduced sepsis mortality by more than 50% ().
I think this is a wonderful advancement to science in medicine. My dad had cancer and died of sepsis. His condition went from being normal to dead in less than 8 hours. To watch a normally healthy man (even though he had cancer) to see the effects on his body within such a short time is the scariest thing you can encounter in person. Four years later I had a simple tonsillectomy only to find out four months later that a small sore on my arm that I had since my surgery was a staph infection, and within 3 days of going to the doctor because it just wouldn't heal, had turned to sepsis. I got it from my surgery along with others who were operated on that day. It also was treated with Keflex at first by my PCP and it took my gynecologist to notice that something was not right. He had me admitted to the ER and found out that I had bacteria in my blood. Sepsis. I almost died from it. So to know that is can take 3 hours to diagnose it now....what a blessing. For all of you who change this from a health issue to a political issue....it doesnt matter who you are when you get sepsis. Republican or Democrat, Medicaid, medicare or nothing. You can die within hours from sepsis unless your doctors identify it and treat it. I pray to God that more people are saved from this terrible, fast acting bacteria now.