Examine the Effects of Maintaining Body Core Temperature During CABGs

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00791050

Enrollment

300

Registered

2008-11-14

Start date

2009-01-31

Completion date

2010-03-31

Last updated

2008-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Coronary Artery Bypass Grafting, Hypothermia

Keywords

Hypothermia/complications/etiology, coronary artery bypass/adverse effects

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.

Interventions

DEVICEAllon Thermowrap. MTRE Advanced Technologies Ltd.

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
Rate of atrial fibrillation	First 48 postoperative hours
Rate of acute renal failure	First 48 postoperative hours

Secondary

Measure	Time frame
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
Rate of Myocardial infarction and low output syndrome	First postoperative 48 hours
Hospital length of stay	30 postoperative days
Cardiac Troponin I (cTnI) curve	First postoperative 24 hours
Intensive Care Unit length of stay	30 postoperative days
Rate of Type I neurological injury	First 48 postoperative hours

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026