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
  Purpose

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
Patients Undergoing Cardiac Surgery

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University of Luebeck:

Primary Outcome Measures:
  • Mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Morbidity [ Time Frame: Within hospital ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

Plasma and urinary samples.


Enrollment: 765
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients scheduled for cardiac surgery

Criteria

Inclusion Criteria:

  • all patients scheduled for cardiac surgery

Exclusion Criteria:

  • age less than 18 years
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01409941

Sponsors and Collaborators
University of Luebeck
Investigators
Principal Investigator: Matthias Heringlake, MD Department of Anesthesiology, University of Luebeck
  More Information

No publications provided

Responsible Party: Matthias Heringlake, Prof. Dr. med. Matthias Heringlake, University of Luebeck
ClinicalTrials.gov Identifier: NCT01409941     History of Changes
Other Study ID Numbers: CS_RS_2008-2009 - ScO2
Study First Received: August 3, 2011
Last Updated: December 22, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Luebeck:
cerebral oxygen saturation,
NTproBNP
hsTNT
GDF-15

ClinicalTrials.gov processed this record on August 27, 2015