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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01409941
Recruitment Status : Completed
First Posted : August 4, 2011
Last Update Posted : December 23, 2014
Information provided by (Responsible Party):
Matthias Heringlake, University of Luebeck

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
Patients Undergoing Cardiac Surgery

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 : January 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Primary Outcome Measures :
  1. Mortality [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Morbidity [ Time Frame: Within hospital ]

Biospecimen Retention:   Samples Without DNA
Plasma and urinary samples.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients scheduled for cardiac surgery

Inclusion Criteria:

  • all patients scheduled for cardiac surgery

Exclusion Criteria:

  • age less than 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01409941

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

Responsible Party: Matthias Heringlake, Prof. Dr. med. Matthias Heringlake, University of Luebeck Identifier: NCT01409941     History of Changes
Other Study ID Numbers: CS_RS_2008-2009 - ScO2
First Posted: August 4, 2011    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014

Keywords provided by Matthias Heringlake, University of Luebeck:
cerebral oxygen saturation,