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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Manfred Weiss, University of Ulm
ClinicalTrials.gov Identifier:
NCT00736723
First received: August 14, 2008
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
  Purpose

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
SIRS
Sepsis
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:

MedlinePlus related topics: Sepsis Shock
U.S. FDA Resources

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)
Groups/Cohorts
A
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736723

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

No publications provided

Responsible Party: Manfred Weiss, Professor, MD, MBA, University of Ulm
ClinicalTrials.gov 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:
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:
Critical Illness
Multiple Organ Failure
Sepsis
Toxemia
Shock
 Disease Attributes
Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on June 17, 2013