Examine the Effects of Maintaining Body Core Temperature During CABGs

Study Overview
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Brief Summary
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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.

Official Title
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To Examine the Effects on Patients Outcomes of Maintaining Body Core Temperature During CABGs With Thermowrap

Conditions
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Anesthesia, Hypothermia, Coronary Artery Bypass Grafting

Intervention / Treatment
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* Device: Allon Thermowrap. MTRE Advanced Technologies Ltd.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Thermo<br> | Device: Allon Thermowrap. MTRE Advanced Technologies Ltd.<br>* Thermowrap set at 37 °C before induction of anesthesia and maintained until initiation of CPB; during CPB set to monitoring and set again to 37 °C from rewarming during CPB to end of surgery.<br>|
| No Intervention: 2 Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of atrial fibrillation |  | First 48 postoperative hours | 
| Rate of acute renal failure |  | First 48 postoperative hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypothermia/complications/etiology, coronary artery bypass/adverse effects