NT-proBNP in ICU Postoperative/Posttraumatic Patients With Shock

Study Overview
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Brief Summary
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The purpose of this study is to determine the course of NT-proBNP plasma concentrations in the context of confounding parameters in postoperative/posttraumatic critically ill patients with severe SIRS/sepsis and shock.

Detailed Description
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In the recent sepsis-definitions, myocardial depression is included in the definition of severe sepsis, indicated as lowered cardiac index or echocardiographically documented cardiac dysfunction. Myocardial dysfunction occurs in greater than 50% of patients with severe sepsis and septic shock. In this context, B-type natriuretic peptid (BNP) from ventricular myocytes may serve as a surrogate biomarker for the evaluation and quantification of myocardial dysfunction. Biologically active BNP is cleaved into inactive NT-proBNP, which is supposed to be a better marker of myocardial dysfunction and prognosis in patients with severe sepsis and septic shock. However, severity of illness dependent association of myocardial dysfunction, especially left ventricular diastolic function, dosage of norepinephrine, NT-proBNP and biomarker plasma concentrations has not been systematically investigated in postoperative/posttraumatic patients in septic shock or volume-deficiency/hemorrhagic shock. Moreover, data regarding NT-proBNP plasma concentrations and renal function in postoperative/posttraumatic patients are sparse. Therefore, this prospective observational study will enroll n= 200 postoperative/posttraumatic patients to monitor longitudinally NT-proBNP, biomarkers, and cell surface markers on leukocytes to find out whether there is a discriminating pattern of myocardial dysfunction, NT-proBNP and biomarkers in patients with non-septic or septic shock, respectively, and with beneficial or harmful outcome.

Official Title
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NT-proBNP in Postoperative/Posttraumatic Critically Ill Patients With Severe SIRS/Sepsis and Shock

Conditions
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SIRS, Sepsis, Shock, Critically Ill, Multiple Organ Dysfunction Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Critically ill, postoperative/posttraumatic patients with severe systemic inflammatory response syndrome (SIRS) or severe sepsis Exclusion Criteria: Life expectancy < 24 hours Participation in other trials Known or suspected pregnancy Contraindications for transesophageal echocardiography (TEE): severe disease of the esophagus (hernia, strictures, esophageal resection, severe bleeding disorders)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients non-septic shock<br>Postoperative/posttraumatic critically ill patients with non-septic shock | |
| Patients septic shock<br>Postoperative/posttraumatic critically ill patients with septic shock | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pattern of NT-proBNP, Biomarkers and Surface Markers on Leukocytes | maximal NT-proBNP concentrations in critically ill surgical patients admitted from 01 July 2008 to 31 Dec 2008 in the ICU revealingnonseptic and septic shock | 01 July 2008 to 31 Dec 2008 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NT-proBNP, myocardial dysfunction, humans, patients, polytrauma, complement, inflammation, inflammatory response, biomarkers, cytokines, cell surface markers, functional polymorphisms, infections, systemic inflammatory response syndrome, SIRS, sepsis, severe sepsis, shock, organ dysfunctions, SOFA, severity of disease, APACHEII, SAPSII, SPAPS3, length of stay, outcome, mortality