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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
Sponsor:
Information provided by:
Centro Cardiologico Monzino
ClinicalTrials.gov Identifier:
NCT00791050
First received: November 13, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose
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
Anesthesia
Hypothermia
Coronary Artery Bypass Grafting
Device: Allon Thermowrap. MTRE Advanced Technologies Ltd.

Study Type: Interventional
Study Design: Allocation: Randomized
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 ]
  • Rate of acute renal failure [ Time Frame: First 48 postoperative hours ]

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

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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791050

Locations
Italy
Dept. of Anesthesia & ICU, IRCCS Centro Cardiologico Monzino Not yet recruiting
Milano, Italy
Contact    + 39 02 58002541    anestesisti@ccfm.it   
Principal Investigator: Luca Salvi, MD         
Sponsors and Collaborators
Centro Cardiologico Monzino
Investigators
Principal Investigator: Luca Salvi, MD Dept. of Anesthesia & ICU, IRCCS Centro Cardiologico Monzino. Milano, Italy
  More Information

Publications:
Responsible Party: Luca Salvi, MD, IRCCS Centro Cardiologico Monzino
ClinicalTrials.gov Identifier: NCT00791050     History of Changes
Other Study ID Numbers: CCMAneste002
Study First Received: November 13, 2008
Last Updated: November 13, 2008

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

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on April 27, 2017