Examine the Effects of Maintaining Body Core Temperature During CABGs

Not Applicable

• Conditions: Anesthesia; Hypothermia; Coronary Artery Bypass Grafting
• Interventions: Device: Allon Thermowrap. MTRE Advanced Technologies Ltd.

• Registration Number: NCT00791050
• Lead Sponsor: Centro Cardiologico Monzino

Brief Summary

Although data on cardioprotective effects (as profile of troponin I)of perioperative maintenance of normothermia during CABGs are already known, little is known about the effects of maintaining normothermia on clinical outcomes of patients submitted to coronary surgery. Being acute renal failure (ARF) and atrial fibrillation (AF) the two most frequent complications of this surgery, this study compare as primary end point the rate of postoperative ARF and AF in two group of patients, one actively warmed with Thermowrap and the control group receiving standard institutional care.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-10
• Study First Submitted: 2008-11-13
• Study First Submitted QC: 2008-11-13
• Last Update Submitted: 2008-11-13
• Study First Posted: 2008-11-14
• Last Update Posted: 2008-11-14
• Study Start: 2009-01
• Primary Completion: 2010-01
• Study Completion: 2010-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Isolated on pump CABGs
• Age 18 - 85
• Preoperative core temperature 36- 37.5 °C

Exclusion Criteria

• History of fever in the last week
• Severe renal, hepatic,hematologic or pulmonary disease
• Chronic Atrial fibrillation
• History of acute MI in the last week
• Previous neurologic abnormalities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 Thermo	Allon Thermowrap. MTRE Advanced Technologies Ltd.	-

Primary Outcome Measures

Name	Time	Method
Rate of atrial fibrillation	First 48 postoperative hours
Rate of acute renal failure	First 48 postoperative hours

Secondary Outcome Measures

Name	Time	Method
Rate of Myocardial infarction and low output syndrome	First postoperative 48 hours
Rate of Type I neurological injury	First 48 postoperative hours
Total units of RBCs transfused	First 48 postoperative hours
Length of mechanical ventilation	First 48 postoperative hours
Rate of in-hospital mortality	30 postoperative days
Intensive Care Unit length of stay	30 postoperative days
Hospital length of stay	30 postoperative days
Cardiac Troponin I (cTnI) curve	First postoperative 24 hours

Trial Locations

Locations (1)

Dept. of Anesthesia & ICU, IRCCS Centro Cardiologico Monzino; 🇮🇹 Milano, Italy