Examine the Effects of Maintaining Body Core Temperature During CABGs

NCT ID: NCT00791050

Last Updated: 2008-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-03-31

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.

Detailed Description

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Conditions

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Anesthesia Hypothermia Coronary Artery Bypass Grafting

Keywords

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Hypothermia/complications/etiology coronary artery bypass/adverse effects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1 Thermo

Group Type EXPERIMENTAL

Allon Thermowrap. MTRE Advanced Technologies Ltd.

Intervention Type DEVICE

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.

2 Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Allon 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.

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Cardiologico Monzino

OTHER

Sponsor Role lead

Responsible Party

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IRCCS Centro Cardiologico Monzino

Principal Investigators

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Luca Salvi, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Dept. of Anesthesia & ICU, IRCCS Centro Cardiologico Monzino

Milan, , Italy

Site Status

Countries

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Italy

Facility Contacts

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Role: primary

References

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Nesher N, Zisman E, Wolf T, Sharony R, Bolotin G, David M, Uretzky G, Pizov R. Strict thermoregulation attenuates myocardial injury during coronary artery bypass graft surgery as reflected by reduced levels of cardiac-specific troponin I. Anesth Analg. 2003 Feb;96(2):328-35, table of contents. doi: 10.1097/00000539-200302000-00007.

Reference Type BACKGROUND
PMID: 12538173 (View on PubMed)

Other Identifiers

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CCMAneste002

Identifier Type: -

Identifier Source: org_study_id