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Examine the Effects of Maintaining Body Core Temperature During CABGs

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by Centro Cardiologico Monzino.
Recruitment status was:  Not yet recruiting
Information provided by:
Centro Cardiologico Monzino Identifier:
First received: November 13, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
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.

Condition Intervention
Coronary Artery Bypass Grafting
Device: Allon Thermowrap. MTRE Advanced Technologies Ltd.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: To Examine the Effects on Patients Outcomes of Maintaining Body Core Temperature During CABGs With Thermowrap

Further study details as provided by Centro Cardiologico Monzino:

Primary Outcome Measures:
  • Rate of atrial fibrillation [ Time Frame: First 48 postoperative hours ] [ Designated as safety issue: No ]
  • Rate of acute renal failure [ Time Frame: First 48 postoperative hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of Myocardial infarction and low output syndrome [ Time Frame: First postoperative 48 hours ] [ Designated as safety issue: No ]
  • Rate of Type I neurological injury [ Time Frame: First 48 postoperative hours ] [ Designated as safety issue: No ]
  • Total units of RBCs transfused [ Time Frame: First 48 postoperative hours ] [ Designated as safety issue: No ]
  • Length of mechanical ventilation [ Time Frame: First 48 postoperative hours ] [ Designated as safety issue: No ]
  • Rate of in-hospital mortality [ Time Frame: 30 postoperative days ] [ Designated as safety issue: No ]
  • Intensive Care Unit length of stay [ Time Frame: 30 postoperative days ] [ Designated as safety issue: No ]
  • Hospital length of stay [ Time Frame: 30 postoperative days ] [ Designated as safety issue: No ]
  • Cardiac Troponin I (cTnI) curve [ Time Frame: First postoperative 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Thermo 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.
No Intervention: 2 Control


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00791050

Dept. of Anesthesia & ICU, IRCCS Centro Cardiologico Monzino
Milano, Italy
Sponsors and Collaborators
Centro Cardiologico Monzino
Principal Investigator: Luca Salvi, MD Dept. of Anesthesia & ICU, IRCCS Centro Cardiologico Monzino. Milano, Italy
  More Information

Responsible Party: Luca Salvi, MD, IRCCS Centro Cardiologico Monzino Identifier: NCT00791050     History of Changes
Other Study ID Numbers: CCMAneste002 
Study First Received: November 13, 2008
Last Updated: November 13, 2008
Health Authority: Italy: Ministry of Health

Keywords provided by Centro Cardiologico Monzino:
coronary artery bypass/adverse effects

Additional relevant MeSH terms:
Body Temperature Changes
Signs and Symptoms processed this record on January 17, 2017