NT-proBNP in ICU Postoperative/Posttraumatic Patients With Shock

Sepsis Clinical Trial

— NICUPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736723
• Other study ID #: Anae_ICU_Ulm_NT-proBNP
• Status: Completed
• Phase: N/A
• First received: August 14, 2008
• Last updated: February 5, 2013
• Start date: August 2008
• Est. completion date: December 2012

Study information

• Verified date: February 2013
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Multiple Organ Dysfunction Syndrome
• Multiple Organ Failure
• Sepsis
• Shock
• SIRS

Locations

Country	Name	City	State
Germany	Clinic of Anesthesiology	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Weiss M, Huber M, Nass M, Huber-Lang M, Koenig W, Schneider M. NT-proBNP and HMGB1 in surgical critically ill patients with hypovolemic or septic shock.Infection Suppl. II September 2011; 39: S116-117 5th International Congress of the German Sepsis Societ

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between NT-proBNP and myocardial dysfunction		First days with SIRS/shock with relation to distinct norepinephrine and epinephrine drug concentrations	No
Secondary	Pattern of NT-proBNP, biomarkers and surface markers on leukocytes		First days with and without severe SIRS/sepsis or shock dependent on distinct norepinephrine and epinephrine drug concentrations, before demission from ICU or death	No