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

Patients Undergoing Cardiac Surgery Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01409941
• Other study ID #: CS_RS_2008-2009 - ScO2
• Status: Completed
• Phase: N/A
• First received: August 3, 2011
• Last updated: December 22, 2014
• Start date: January 2009
• Est. completion date: December 2011

Study information

• Verified date: December 2014
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 765
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all patients scheduled for cardiac surgery

Exclusion Criteria:

• age less than 18 years

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Patients Undergoing Cardiac Surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Luebeck

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		1 year	Yes
Secondary	Morbidity		Within hospital	Yes