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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Matthias Heringlake, University of Luebeck
ClinicalTrials.gov Identifier:
NCT01409941
First received: August 3, 2011
Last updated: December 22, 2014
Last verified: December 2014

August 3, 2011
December 22, 2014
January 2009
December 2010   (final data collection date for primary outcome measure)
Mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT01409941 on ClinicalTrials.gov Archive Site
Morbidity [ Time Frame: Within hospital ] [ Designated as safety issue: Yes ]
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The Relation Between Preoperative ScO2 and the Postoperative Course of Humoral Organ Dysfunction Markers.
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.

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)

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

Plasma and urinary samples.

Probability Sample

Patients scheduled for cardiac surgery

Patients Undergoing Cardiac Surgery
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
765
December 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • all patients scheduled for cardiac surgery

Exclusion Criteria:

  • age less than 18 years
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01409941
CS_RS_2008-2009 - ScO2
No
Matthias Heringlake, University of Luebeck
University of Luebeck
Not Provided
Principal Investigator: Matthias Heringlake, MD Department of Anesthesiology, University of Luebeck
University of Luebeck
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP