MedTrace Logo

Examine the Effects of Maintaining Body Core Temperature During CABGs

NCT00791050 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2008-11-14

No results posted yet for this study

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.

Conditions

  • Anesthesia
  • Hypothermia
  • Coronary Artery Bypass Grafting

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Centro Cardiologico Monzino

    lead OTHER

Principal Investigators

  • Luca Salvi, MD · Dept. of Anesthesia & ICU, IRCCS Centro Cardiologico Monzino. Milano, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-01-31
Completion
2010-03-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00791050 on ClinicalTrials.gov