Tissue Oxygenation During Heart Surgery

Completed

• Conditions: Coronary Artery Bypass Grafting
• Interventions: Device: measurements of brain tissue oxygenation

• Registration Number: NCT01347827
• Lead Sponsor: University Medical Center Groningen

Brief Summary

The goal of this study is to determine if off-pump CABG surgery is associated with better cerebral tissue oxygenation when compared with on-pump CABG. In addition, the investigators would like to compare the results of two different monitors of brain tissue oxygenation with each other, and assess the correlation between brain tissue oxygenation and oxygenation measurements in renal and muscular tissue, as well as with conventional hemodynamic and metabolic variables, such as central venous oxygen saturation (ScvO2). Finally, the investigators aim to determine if duration and extent of cerebral oxygen desaturation predict outcome variables such as postoperative cognitive performance.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-27
• Study First Submitted QC: 2011-05-03
• Study First Posted: 2011-05-04
• Study Start: 2011-06
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age ≥18 years
• Informed patient consent
• Coronary artery disease suitable for both on-pump and off-pump CABG surgery.

Exclusion Criteria

• History of head trauma or stroke causing significant active neurologic disease
• History of neurosurgery
• Severe or symptomatic carotid artery disease
• Requirement for valve surgery in addition to CABG
• Pre-existing acute or chronic renal dysfunction
• Urgent or emergency surgery
• Difficulty with cognitive testing: impaired hearing or eyesight, poor Dutch language comprehension, disability impairing the usage of the hand or arm.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
on pump	measurements of brain tissue oxygenation	Coronary artery bypass grafting (CABG)with with cardiopulmonary bypass
off pump	measurements of brain tissue oxygenation	off-pump CABG surgery

Primary Outcome Measures

Name	Time	Method
incidence of significant brain tissue oxygen desaturation, defined as AUC40 > 600 %.sec (a function of both duration (in seconds) and severity (saturation < 40%) of desaturation).	3 months

Secondary Outcome Measures

Name	Time	Method
Oxygenation measurements: Peripheral muscle StO2, cerebral and renal StO2, ScvO2, SaO2, arteriovenous oxygen difference, pO2 Acid-base status: pH, pCO2, HCO3-, ABE, lactate	3 months	* To determine if oxygenation measurements obtained in peripheral (thenar) muscle, renal tissue and in cerebral tissue correlate with each other; * To determine if oxygenation measurements obtained in peripheral (thenar) muscle, renal tissue and in cerebral tissue correlate with conventional hemodynamic and metabolic variables such as central venous oxygen saturation (ScvO2).

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands