Role of Cerebral Oximetry in Reducing Postoperative Morbidity Following Cardiac Surgery

Not Applicable

Completed

• Conditions: Postoperative Complications
• Interventions: Other: Correction rSO2 desaturation.; Other: Standard treatment

• Registration Number: NCT02155868
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief Summary

Cerebral oximetry employing near-infrared spectroscopy (NIRS) is a non-invasive modality used to estimate regional cerebral oxygen content saturation (rSO2). Near-infrared spectroscopy has increasingly been used in perioperative setting of heart surgery and many studies have outlined an increased incidence of postoperative morbidity in patients with significant perioperative reductions in rSO2. Although a relationship between rSO2 reductions and adverse outcomes has been reported, there is not compelling evidence that interventions to correct rSO2 during cardiac surgery lead to improved clinical outcomes.

Hypothesis of the study is that interventions to normalize intraoperatively decreased cerebral rSO2 would reduce the overall incidence of postoperative complications in high-risk cardiac surgery patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-31
• Study Start: 2014-06
• Study First Submitted QC: 2014-06-03
• Study First Posted: 2014-06-04
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-25
• Last Update Posted: 2017-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

High-risk cardiac surgery patients as determined by at least one of the followings:

• the age greater than or equal to 75 years on the day of screening;
• left ventricle ejection fraction less than 35%;
• use of a preoperative intraaortic balloon pump;
• combined valve and coronary artery surgery or multiple valve surgery in patients who have congestive heart failure, or renal insufficiency (creatinine clearance < 60 ml/min)

Exclusion Criteria

• refusal of consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Correction rSO2 desaturation.	Cerebral NIRS monitoring by means of FORE-SIGHT Universal Cerebral Oximeter MC-2030C. Predefined protocol of interventions for correcting rSO2 desaturation (\< 60%) during cardiac surgery and the first six hours after it.
Control	Standard treatment	Only cerebral NIRS monitoring by means of FORE-SIGHT Universal Cerebral Oximeter MC-2030C during cardiac surgery and the first six hours after it.

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative complications	Up to 30 day after randomisation	This composite outcome includes: myocardial infarction, stroke, delirium, postoperative cognitive dysfunction, wound infection, mediastinitis, mechanical ventilation more than 24 h, arrhythmia, reoperation for bleeding, acute kidney injury, and acute kidney injury requiring dialysis.

Secondary Outcome Measures

Name	Time	Method
Duration of postoperative hospital stay	Up to 30 day after randomization
Incidence of major organ morbidity and mortality	Up to 30 day after randomization	This outcome includes: stroke, acute kidney injury requiring dialysis, mechanical ventilation more than 48 h, mediastinitis, reoperation, and death
Death from all causes at 30 days	Up to 30 day after randomisation
Duration of intensive care unit stay	Up to 30 day after randomization

Trial Locations

Locations (1)

Academician EN Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Novosibirsk Territory, Russian Federation