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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00736723
Recruitment Status : Completed
First Posted : August 18, 2008
Results First Posted : January 20, 2017
Last Update Posted : January 20, 2017
Information provided by (Responsible Party):
Manfred Weiss, University of Ulm

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

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

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

Information from the National Library of Medicine

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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

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00736723

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

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Responsible Party: Manfred Weiss, Professor, MD, MBA, University of Ulm Identifier: NCT00736723    
Other Study ID Numbers: Anae_ICU_Ulm_NT-proBNP
First Posted: August 18, 2008    Key Record Dates
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:
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:
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Critical Illness
Multiple Organ Failure
Pathologic Processes
Systemic Inflammatory Response Syndrome
Disease Attributes