NT-proBNP in ICU Postoperative/Posttraumatic Patients With Shock (NICUPS)

• ClinicalTrials.gov Identifier: NCT00736723
• Recruitment Status: Completed
• First Posted: August 18, 2008
• Results First Posted: January 20, 2017
• Last Update Posted: January 20, 2017
• Sponsor: University of Ulm
• Information provided by (Responsible Party): Manfred Weiss, University of Ulm

Study Description

Brief 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.

Condition or disease
SIRS; Sepsis; Shock; Critically Ill; Multiple Organ Dysfunction Syndrome

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 51 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: NT-proBNP in Postoperative/Posttraumatic Critically Ill Patients With Severe SIRS/Sepsis and Shock
• Study Start Date: August 2008
• Actual Primary Completion Date: August 2012
• Actual Study Completion Date: December 2012

Groups and Cohorts

Group/Cohort
Patients non-septic shock; Postoperative/posttraumatic critically ill patients with non-septic shock
Patients septic shock; Postoperative/posttraumatic critically ill patients with septic shock

Outcome Measures

Primary Outcome Measures :

1. Pattern of NT-proBNP, Biomarkers and Surface Markers on Leukocytes [ Time Frame: 01 July 2008 to 31 Dec 2008 ]
   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

Biospecimen Retention:   Samples With DNA

Whole blood, serum, white blood cells

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Postoperative/posttraumatic critically ill patients admitted to the intensive care unit

Criteria

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)

Contacts and Locations

Locations

Germany

Clinic of Anesthesiology

Ulm, Germany, 89070

Sponsors and Collaborators

University of Ulm

Investigators

• Principal Investigator: Manfred Weiss, MD, MBA; Clinic of Anesthesiology, University Hospital Medical School, Steinhoevelstrasse 9, 89070 Ulm, Germany

More Information

Publications of Results:

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 Society, Weimar Sepsis Update Bridging The Gap, Weimar, 07. - 10.09.2011.

Weiss M, Huber M, Nass M, Huber-Lang M, Koenig W, Schneider M. NT-proBNP serum concentrations in surgical critically ill patients with non-septic and septic shock. INNOVATIVE JOURNAL OF MEDICAL AND HEALTH SCIENCE 3 (4): 177-184, 2013.

• Responsible Party: Manfred Weiss, Professor, MD, MBA, University of Ulm
• ClinicalTrials.gov Identifier: NCT00736723
• Other Study ID Numbers: Anae_ICU_Ulm_NT-proBNP
• First Posted: August 18, 2008
• Results First Posted: January 20, 2017
• Last Update Posted: January 20, 2017
• Last Verified: November 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Keywords provided by Manfred Weiss, University of Ulm:

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

Additional relevant MeSH terms:

Sepsis; Toxemia; Shock; Critical Illness; Multiple Organ Failure; Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes