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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
University of Luebeck
ClinicalTrials.gov Identifier:
NCT01409941
First received: August 3, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  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 syndrom, 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 (NTproBNP, hsTNT, GDF-15, s-FLT1, and PIGF)


Condition
Cardiac Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Prognostic Relevance of NTproBNP, Cerebral Oxygen Saturation, and Preoperative Creatinine Clearance in Carduac Surgery Patients - Amendment 2: the Role of NTproBNP and ScO2 in Predicting Mortality and Postoperative Organ Dysfunction.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Luebeck:

Biospecimen Retention:   Samples Without DNA

Plasma and urinary samples.


Estimated Enrollment: 800
Study Start Date: January 2009
Estimated Study Completion Date: September 2011
Primary Completion Date: January 2011 (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
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, Department of Anesthesiology, 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: August 3, 2011
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 June 17, 2013