NT-proBNP in ICU Postoperative/Posttraumatic Patients With Shock

NCT ID: NCT00736723

Last Updated: 2025-01-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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SIRS Sepsis Shock Critically Ill Multiple Organ Dysfunction Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients non-septic shock

Postoperative/posttraumatic critically ill patients with non-septic shock

No interventions assigned to this group

Patients septic shock

Postoperative/posttraumatic critically ill patients with septic shock

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ulm

OTHER

Sponsor Role lead

Responsible Party

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Manfred Weiss

Professor, MD, MBA

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manfred Weiss, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Clinic of Anesthesiology, University Hospital Medical School, Steinhoevelstrasse 9, 89070 Ulm, Germany

Locations

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Clinic of Anesthesiology

Ulm, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT

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.

Reference Type RESULT

Other Identifiers

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Anae_ICU_Ulm_NT-proBNP

Identifier Type: -

Identifier Source: org_study_id

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