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

Sponsor
University of Luebeck (Other)
Overall Status
Completed
CT.gov ID
NCT01409941
Collaborator
(none)
765
Enrollment
35
Duration (Months)

Study Details

Study Description

Brief Summary

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)

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    765 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Prognostic Relevance of N-terminal Pro B-type Natriuretic Peptide(NTproBNP), Cerebral Oxygen Saturation (ScO2), and Preoperative Creatinine Clearance in Cardiac Surgery Patients - Amendment 2: the Role of NTproBNP and ScO2 in Predicting Mortality and Postoperative Organ Dysfunction.
    Study Start Date :
    Jan 1, 2009
    Actual Primary Completion Date :
    Dec 1, 2010
    Actual Study Completion Date :
    Dec 1, 2011

    Outcome Measures

    Primary Outcome Measures

    1. Mortality [1 year]

    Secondary Outcome Measures

    1. Morbidity [Within hospital]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • all patients scheduled for cardiac surgery
    Exclusion Criteria:
    • age less than 18 years

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Luebeck

    Investigators

    • Principal Investigator: Matthias Heringlake, MD, Department of Anesthesiology, University of Luebeck

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Matthias Heringlake, Prof. Dr. med. Matthias Heringlake, University of Luebeck
    ClinicalTrials.gov Identifier:
    NCT01409941
    Other Study ID Numbers:
    • CS_RS_2008-2009 - ScO2
    First Posted:
    Aug 4, 2011
    Last Update Posted:
    Dec 23, 2014
    Last Verified:
    Dec 1, 2014
    Keywords provided by Matthias Heringlake, Prof. Dr. med. Matthias Heringlake, University of Luebeck
    cerebral oxygen saturation,
    NTproBNP
    hsTNT
    GDF-15

    Study Results

    No Results Posted as of Dec 23, 2014