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

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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Shock; Critically Ill; SIRS; 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 Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• Germany
  • Ulm, Germany, 89070
    • Clinic of Anesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: August 14, 2008
• First Submitted That Met QC Criteria: August 15, 2008
• First Posted (Estimated): August 18, 2008

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: patients; biomarkers; complement; outcome; infections; shock; inflammation; sepsis; mortality; systemic inflammatory response syndrome; cytokines; SIRS; severe sepsis; humans; inflammatory response; cell surface markers; functional polymorphisms; length of stay; polytrauma; NT-proBNP; organ dysfunctions; SOFA; severity of disease; APACHEII; SAPSII; SPAPS3; myocardial dysfunction
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Critical Illness; Sepsis; Shock; Toxemia; Multiple Organ Failure
• Other Study ID Numbers: Anae_ICU_Ulm_NT-proBNP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO