Simple, straightforward system should inform future studies
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Patients with sepsis-associated coagulopathy appear to be at heightened risk of death, according to results of a large retrospective cohort study.

The risk of death in the study increased with the severity of the sepsis-associated coagulopathy, which was defined using international normalized ratio (INR) and platelet counts.

Those findings suggest that the severity of coagulation abnormalities might be used to quantify mortality risk, according to investigator Patrick G. Lyons, MD, of the division of pulmonary and critical care medicine, Washington University, St. Louis, and his coinvestigators.

“Future trials of sepsis therapies targeting the coagulation cascade should take into account the presence or absence of sepsis-associated coagulopathy, as well as the severity of sepsis-associated coagulopathy, when formulating potential trial designs,” the investigators wrote in the journal Critical Care Medicine.

Their retrospective cohort study included 6,148 consecutive patients with sepsis or septic shock hospitalized at a 1,300-bed urban academic medical center between 2010 and 2015. Of that group, 26% had sepsis-associated coagulopathy, defined as having both an INR of 1.2 or higher and a platelet count less than 150,000/mcL. Sepsis-associated coagulopathy was classified as mild for 4%, moderate for 16%, and severe for 6% of the cohort.

Hospital mortality was 25.4% for patients with no sepsis-associated coagulopathy, the research team found, increasing progressively from 27.0% for mild, 40.7% for moderate, and 56.1% for patients in the most severe category of sepsis-associated coagulopathy (P less than .001).

Hospital and ICU days also increased progressively according to the severity of coagulopathy, they reported.

 

 


Both presence and severity of sepsis-associated coagulopathy remained independently associated with hospital mortality even after adjustments were made for patient characteristics, hospitalization variables, and interactions between sepsis-associated coagulopathy and cancer, investigators said. Odds ratios ranged from 1.33 to 2.14 for presence of sepsis-associated coagulopathy, and from 1.18 to 1.51 for severity, they reported in the journal.

These data have potential implications for managing patients with sepsis, according to Dr. Lyons and coinvestigators. In particular, severity of sepsis-associated coagulopathy might be used as “another relatively simple way” to compare sepsis patient populations, similar to other markers of severity such as the Sequential Organ Failure Assessment score.

“This could have important implications for comparing the outcomes of patients with sepsis from different hospitals, especially with increasing requirements for public reporting of such data through systems such as the Severe Sepsis/Septic Shock Early Management Bundle-1 and New York State’s Rory’s Regulations,” the investigators wrote.

Reported disclosures for the study included institutional funding from Asahi Kasei Pharma America by one coauthor, and support from Barnes-Jewish Hospital Foundation by another. No other potential conflicts of interest were reported.

SOURCE: Lyons PG et al. Crit Care Med. 2018 May;46(5):736-42.

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This study outlines a simplified classification scheme for coagulopathy with implications that are potentially “profound,” according to authors of an editorial accompanying the journal article.

“Despite the frequency with which hemostatic derangements occur in sepsis, there has not been a widely accepted system for stratification of coagulopathies,” said editorialists Garrett W. Britton, DO, Cody Babcock, PharmD, and Christopher J. Colombo, MD. “Of the most cited criteria, all have varying concordance, and one does not seem to have an advantage over another.”

In the present study, patients with sepsis-associated coagulopathy were stratified into mild, moderate, and severe categories based on international normalized ratio (INR) levels and platelet counts.

While the study has limitations including a sicker patient cohort and arbitrarily chosen severity thresholds, the investigators did find progressively increasing mortality rates that correlated with severity and were independent of confounding variables.

“Overall, this stratification system will prove useful in identifying target populations in future interventional studies,” the editorial authors wrote.

Since sepsis-related mortality remains high, the ultimate goal of research should be identifying varying phenotypes of the disease and targeting them with specific therapies, they added.

“Lyons et al. have aided the first steps in that process with their straightforward classification scheme for sepsis-associated coagulopathy,” they wrote. “Intelligently designed therapeutic trials ‘evaluating’ the response of these phenotypes to new (or old) pharmacotherapy should be the ultimate goal.”

Garrett W. Britton, DO, is with the department of medicine, critical care section, Walter Reed National Military Medical Center, Bethesda, Md. Cody Babcock, PharmD, and Christopher J. Colombo, MD, are with the department of medicine, critical care section, Dwight David Eisenhower Army Medical Center, Fort Gordon, Ga. These comments are derived from their editorial in Critical Care Medicine . The authors had no disclosures beyond reporting government work.

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This study outlines a simplified classification scheme for coagulopathy with implications that are potentially “profound,” according to authors of an editorial accompanying the journal article.

“Despite the frequency with which hemostatic derangements occur in sepsis, there has not been a widely accepted system for stratification of coagulopathies,” said editorialists Garrett W. Britton, DO, Cody Babcock, PharmD, and Christopher J. Colombo, MD. “Of the most cited criteria, all have varying concordance, and one does not seem to have an advantage over another.”

In the present study, patients with sepsis-associated coagulopathy were stratified into mild, moderate, and severe categories based on international normalized ratio (INR) levels and platelet counts.

While the study has limitations including a sicker patient cohort and arbitrarily chosen severity thresholds, the investigators did find progressively increasing mortality rates that correlated with severity and were independent of confounding variables.

“Overall, this stratification system will prove useful in identifying target populations in future interventional studies,” the editorial authors wrote.

Since sepsis-related mortality remains high, the ultimate goal of research should be identifying varying phenotypes of the disease and targeting them with specific therapies, they added.

“Lyons et al. have aided the first steps in that process with their straightforward classification scheme for sepsis-associated coagulopathy,” they wrote. “Intelligently designed therapeutic trials ‘evaluating’ the response of these phenotypes to new (or old) pharmacotherapy should be the ultimate goal.”

Garrett W. Britton, DO, is with the department of medicine, critical care section, Walter Reed National Military Medical Center, Bethesda, Md. Cody Babcock, PharmD, and Christopher J. Colombo, MD, are with the department of medicine, critical care section, Dwight David Eisenhower Army Medical Center, Fort Gordon, Ga. These comments are derived from their editorial in Critical Care Medicine . The authors had no disclosures beyond reporting government work.

Body

 

This study outlines a simplified classification scheme for coagulopathy with implications that are potentially “profound,” according to authors of an editorial accompanying the journal article.

“Despite the frequency with which hemostatic derangements occur in sepsis, there has not been a widely accepted system for stratification of coagulopathies,” said editorialists Garrett W. Britton, DO, Cody Babcock, PharmD, and Christopher J. Colombo, MD. “Of the most cited criteria, all have varying concordance, and one does not seem to have an advantage over another.”

In the present study, patients with sepsis-associated coagulopathy were stratified into mild, moderate, and severe categories based on international normalized ratio (INR) levels and platelet counts.

While the study has limitations including a sicker patient cohort and arbitrarily chosen severity thresholds, the investigators did find progressively increasing mortality rates that correlated with severity and were independent of confounding variables.

“Overall, this stratification system will prove useful in identifying target populations in future interventional studies,” the editorial authors wrote.

Since sepsis-related mortality remains high, the ultimate goal of research should be identifying varying phenotypes of the disease and targeting them with specific therapies, they added.

“Lyons et al. have aided the first steps in that process with their straightforward classification scheme for sepsis-associated coagulopathy,” they wrote. “Intelligently designed therapeutic trials ‘evaluating’ the response of these phenotypes to new (or old) pharmacotherapy should be the ultimate goal.”

Garrett W. Britton, DO, is with the department of medicine, critical care section, Walter Reed National Military Medical Center, Bethesda, Md. Cody Babcock, PharmD, and Christopher J. Colombo, MD, are with the department of medicine, critical care section, Dwight David Eisenhower Army Medical Center, Fort Gordon, Ga. These comments are derived from their editorial in Critical Care Medicine . The authors had no disclosures beyond reporting government work.

Title
Simple, straightforward system should inform future studies
Simple, straightforward system should inform future studies

 

Patients with sepsis-associated coagulopathy appear to be at heightened risk of death, according to results of a large retrospective cohort study.

The risk of death in the study increased with the severity of the sepsis-associated coagulopathy, which was defined using international normalized ratio (INR) and platelet counts.

Those findings suggest that the severity of coagulation abnormalities might be used to quantify mortality risk, according to investigator Patrick G. Lyons, MD, of the division of pulmonary and critical care medicine, Washington University, St. Louis, and his coinvestigators.

“Future trials of sepsis therapies targeting the coagulation cascade should take into account the presence or absence of sepsis-associated coagulopathy, as well as the severity of sepsis-associated coagulopathy, when formulating potential trial designs,” the investigators wrote in the journal Critical Care Medicine.

Their retrospective cohort study included 6,148 consecutive patients with sepsis or septic shock hospitalized at a 1,300-bed urban academic medical center between 2010 and 2015. Of that group, 26% had sepsis-associated coagulopathy, defined as having both an INR of 1.2 or higher and a platelet count less than 150,000/mcL. Sepsis-associated coagulopathy was classified as mild for 4%, moderate for 16%, and severe for 6% of the cohort.

Hospital mortality was 25.4% for patients with no sepsis-associated coagulopathy, the research team found, increasing progressively from 27.0% for mild, 40.7% for moderate, and 56.1% for patients in the most severe category of sepsis-associated coagulopathy (P less than .001).

Hospital and ICU days also increased progressively according to the severity of coagulopathy, they reported.

 

 


Both presence and severity of sepsis-associated coagulopathy remained independently associated with hospital mortality even after adjustments were made for patient characteristics, hospitalization variables, and interactions between sepsis-associated coagulopathy and cancer, investigators said. Odds ratios ranged from 1.33 to 2.14 for presence of sepsis-associated coagulopathy, and from 1.18 to 1.51 for severity, they reported in the journal.

These data have potential implications for managing patients with sepsis, according to Dr. Lyons and coinvestigators. In particular, severity of sepsis-associated coagulopathy might be used as “another relatively simple way” to compare sepsis patient populations, similar to other markers of severity such as the Sequential Organ Failure Assessment score.

“This could have important implications for comparing the outcomes of patients with sepsis from different hospitals, especially with increasing requirements for public reporting of such data through systems such as the Severe Sepsis/Septic Shock Early Management Bundle-1 and New York State’s Rory’s Regulations,” the investigators wrote.

Reported disclosures for the study included institutional funding from Asahi Kasei Pharma America by one coauthor, and support from Barnes-Jewish Hospital Foundation by another. No other potential conflicts of interest were reported.

SOURCE: Lyons PG et al. Crit Care Med. 2018 May;46(5):736-42.

 

Patients with sepsis-associated coagulopathy appear to be at heightened risk of death, according to results of a large retrospective cohort study.

The risk of death in the study increased with the severity of the sepsis-associated coagulopathy, which was defined using international normalized ratio (INR) and platelet counts.

Those findings suggest that the severity of coagulation abnormalities might be used to quantify mortality risk, according to investigator Patrick G. Lyons, MD, of the division of pulmonary and critical care medicine, Washington University, St. Louis, and his coinvestigators.

“Future trials of sepsis therapies targeting the coagulation cascade should take into account the presence or absence of sepsis-associated coagulopathy, as well as the severity of sepsis-associated coagulopathy, when formulating potential trial designs,” the investigators wrote in the journal Critical Care Medicine.

Their retrospective cohort study included 6,148 consecutive patients with sepsis or septic shock hospitalized at a 1,300-bed urban academic medical center between 2010 and 2015. Of that group, 26% had sepsis-associated coagulopathy, defined as having both an INR of 1.2 or higher and a platelet count less than 150,000/mcL. Sepsis-associated coagulopathy was classified as mild for 4%, moderate for 16%, and severe for 6% of the cohort.

Hospital mortality was 25.4% for patients with no sepsis-associated coagulopathy, the research team found, increasing progressively from 27.0% for mild, 40.7% for moderate, and 56.1% for patients in the most severe category of sepsis-associated coagulopathy (P less than .001).

Hospital and ICU days also increased progressively according to the severity of coagulopathy, they reported.

 

 


Both presence and severity of sepsis-associated coagulopathy remained independently associated with hospital mortality even after adjustments were made for patient characteristics, hospitalization variables, and interactions between sepsis-associated coagulopathy and cancer, investigators said. Odds ratios ranged from 1.33 to 2.14 for presence of sepsis-associated coagulopathy, and from 1.18 to 1.51 for severity, they reported in the journal.

These data have potential implications for managing patients with sepsis, according to Dr. Lyons and coinvestigators. In particular, severity of sepsis-associated coagulopathy might be used as “another relatively simple way” to compare sepsis patient populations, similar to other markers of severity such as the Sequential Organ Failure Assessment score.

“This could have important implications for comparing the outcomes of patients with sepsis from different hospitals, especially with increasing requirements for public reporting of such data through systems such as the Severe Sepsis/Septic Shock Early Management Bundle-1 and New York State’s Rory’s Regulations,” the investigators wrote.

Reported disclosures for the study included institutional funding from Asahi Kasei Pharma America by one coauthor, and support from Barnes-Jewish Hospital Foundation by another. No other potential conflicts of interest were reported.

SOURCE: Lyons PG et al. Crit Care Med. 2018 May;46(5):736-42.

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Key clinical point: Risk of hospital mortality increased incrementally with the severity of sepsis-related coagulopathy.

Major finding: Hospital mortality was 25.4% for patients with no sepsis-associated coagulopathy, increasing progressively up to 56.1% for patients in the most severe category.

Study details: A retrospective cohort study including 6,148 consecutive patients hospitalized at a 1,300-bed urban academic medical center between 2010 and 2015.

Disclosures: One author reported institutional funding from Asahi Kasei Pharma America and another noted support from Barnes-Jewish Hospital Foundation. No other potential conflicts of interest were reported.

Source: Lyons PG et al. Crit Care Med. 2018 May;46(5):73642.

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