Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Information provided by (Responsible Party):
Manfred Weiss, University of Ulm Identifier:
First received: August 14, 2008
Last updated: February 5, 2013
Last verified: February 2013
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.

Critically Ill
Multiple Organ Dysfunction Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: NT-proBNP in Postoperative/Posttraumatic Critically Ill Patients With Severe SIRS/Sepsis and Shock

Resource links provided by NLM:

Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • Association between NT-proBNP and myocardial dysfunction [ Time Frame: First days with SIRS/shock with relation to distinct norepinephrine and epinephrine drug concentrations ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pattern of NT-proBNP, biomarkers and surface markers on leukocytes [ Time Frame: First days with and without severe SIRS/sepsis or shock dependent on distinct norepinephrine and epinephrine drug concentrations, before demission from ICU or death ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Whole blood, serum, white blood cells

Enrollment: 51
Study Start Date: August 2008
Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Postoperative/posttraumatic critically ill patients with severe SIRS/sepsis and shock

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Postoperative/posttraumatic critically ill patients admitted to the intensive care unit

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00736723

Clinic of Anesthesiology
Ulm, Germany, 89070
Sponsors and Collaborators
University of Ulm
Principal Investigator: Manfred Weiss, MD, MBA Clinic of Anesthesiology, University Hospital Medical School, Steinhoevelstrasse 9, 89070 Ulm, Germany
  More Information

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.

Responsible Party: Manfred Weiss, Professor, MD, MBA, University of Ulm Identifier: NCT00736723     History of Changes
Other Study ID Numbers: Anae_ICU_Ulm_NT-proBNP 
Study First Received: August 14, 2008
Last Updated: February 5, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by University of Ulm:
myocardial dysfunction
inflammatory response
cell surface markers
functional polymorphisms
systemic inflammatory response syndrome
severe sepsis
organ dysfunctions
severity of disease
length of stay

Additional relevant MeSH terms:
Critical Illness
Multiple Organ Failure
Systemic Inflammatory Response Syndrome
Pathologic Processes
Disease Attributes processed this record on October 28, 2016