Examine the Effects of Maintaining Body Core Temperature During CABGs

Centro Cardiologico Monzino

Status: Unknown

Conditions: Hypothermia; Coronary Artery Bypass Grafting; Anesthesia

Treatments: Device: Allon Thermowrap. MTRE Advanced Technologies Ltd.

Study type: Interventional

Funder types: Other

Identifiers

NCT00791050

CCMAneste002

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

1 Thermo

Experimental group

Treatment:

Device: Allon Thermowrap. MTRE Advanced Technologies Ltd.

2 Control

No Intervention group