The Relation Between Preoperative ScO2 and the Postoperative Course of Humoral Organ Dysfunction Markers.

NCT ID: NCT01409941

Last Updated: 2014-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

765 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-12-31

Brief Summary

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Cerebral oxygen saturation (ScO2) is a measure of cerebral and systemic oxygen delivery to demand ratio. An observational trial in a heterogeneous cohort of 1078 patients patients revealed that a ScO2 below 50% absolute during oxygen insufflation is an independent predictor of short and long term mortality in patients undergoing on-pump cardiac surgery. Comparably, a low ScO2 was a predictor of postoperative morbidity determined as a combined endpoint of a high dependency unit stay of more than 9 days and/or at least 2 of the major postoperative complications. low cardiac output syndrome, stroke, need of renal replacement therapy or reintubation.

The primary objectives of the present prospective observational study is to determine, if there is an association between preoperative ScO2 and postoperative organ dysfunction determined by sensitive markers of organ dysfunction (N-Terminal pro B-type natriuretic peptide, high sensitive troponin T, growth-differentiation factor 15, soluble -FLT1, and placental growth factor)

Detailed Description

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Conditions

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Patients Undergoing Cardiac Surgery

Keywords

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cerebral oxygen saturation, NTproBNP hsTNT GDF-15

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* all patients scheduled for cardiac surgery

Exclusion Criteria

* age less than 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Luebeck

OTHER

Sponsor Role lead

Responsible Party

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Matthias Heringlake

Prof. Dr. med. Matthias Heringlake

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthias Heringlake, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, University of Luebeck

Other Identifiers

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CS_RS_2008-2009 - ScO2

Identifier Type: -

Identifier Source: org_study_id