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Examine the Effects of Maintaining Body Core Temperature During CABGs

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ClinicalTrials.gov Identifier: NCT00791050
Recruitment Status : Unknown
Verified October 2008 by Centro Cardiologico Monzino.
Recruitment status was:  Not yet recruiting
First Posted : November 14, 2008
Last Update Posted : November 14, 2008
Sponsor:
Information provided by:
Centro Cardiologico Monzino

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anesthesia Hypothermia Coronary Artery Bypass Grafting Device: Allon Thermowrap. MTRE Advanced Technologies Ltd. Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: To Examine the Effects on Patients Outcomes of Maintaining Body Core Temperature During CABGs With Thermowrap
Study Start Date : January 2009
Estimated Primary Completion Date : January 2010
Estimated Study Completion Date : March 2010
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Rate of atrial fibrillation [ Time Frame: First 48 postoperative hours ]
  2. Rate of acute renal failure [ Time Frame: First 48 postoperative hours ]

Secondary Outcome Measures :
  1. Rate of Myocardial infarction and low output syndrome [ Time Frame: First postoperative 48 hours ]
  2. Rate of Type I neurological injury [ Time Frame: First 48 postoperative hours ]
  3. Total units of RBCs transfused [ Time Frame: First 48 postoperative hours ]
  4. Length of mechanical ventilation [ Time Frame: First 48 postoperative hours ]
  5. Rate of in-hospital mortality [ Time Frame: 30 postoperative days ]
  6. Intensive Care Unit length of stay [ Time Frame: 30 postoperative days ]
  7. Hospital length of stay [ Time Frame: 30 postoperative days ]
  8. Cardiac Troponin I (cTnI) curve [ Time Frame: First postoperative 24 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791050


Locations
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Italy
Dept. of Anesthesia & ICU, IRCCS Centro Cardiologico Monzino
Milano, Italy
Contact    + 39 02 58002541    anestesisti@ccfm.it   
Principal Investigator: Luca Salvi, MD         
Sponsors and Collaborators
Centro Cardiologico Monzino
Investigators
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Principal Investigator: Luca Salvi, MD Dept. of Anesthesia & ICU, IRCCS Centro Cardiologico Monzino. Milano, Italy
More Information
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Publications:

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Responsible Party: Luca Salvi, MD, IRCCS Centro Cardiologico Monzino
ClinicalTrials.gov Identifier: NCT00791050    
Other Study ID Numbers: CCMAneste002
First Posted: November 14, 2008    Key Record Dates
Last Update Posted: November 14, 2008
Last Verified: October 2008
Keywords provided by Centro Cardiologico Monzino:
Hypothermia/complications/etiology
coronary artery bypass/adverse effects
Additional relevant MeSH terms:
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Hypothermia
Body Temperature Changes