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Effect of Rewarming Rate During Cardiopulmonary Bypass on Clinical Prognosis of Infants Undergoing Cardiac Surgery

This study is not yet open for participant recruitment.
Verified July 2011 by Xijing Hospital
Sponsor:
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01398709
First received: July 11, 2011
Last updated: July 19, 2011
Last verified: July 2011
History of Changes
  Purpose

The purpose of this study is to investigate the relationship between rewarming rate during cardiopulmonary bypass and clinical prognosis in infants undergoing cardiac surgery.


Condition Intervention Phase
Cardiac Surgery
Cardiopulmonary Bypass
Rewarming Rate
 Other: Slow rewarming strategy
Other: Fast rewarming strategy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Study of the Relationship Between Rewarming Rate During Cardiopulmonary Bypass and Clinical Prognosis in Infants Undergoing Cardiac Surgery

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • all cause mortality [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acute renal failure [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Respiratory failure [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • ICU and hospital length of stay, and ICU readmissions [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Stroke and reversible ischemic neurologic deficit [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Measures of inflammation [ Time Frame: one month ] [ Designated as safety issue: Yes ]
    Measures of inflammation (C-reactive protein, TNF-alpha; IL-6) and oxidative stress markers

  • Biochemical markers of myocardial necrosis [ Time Frame: one month ] [ Designated as safety issue: Yes ]
    Biochemical markers of myocardial necrosis（troponin and creatine kinase MB）

  • Perioperative complications [ Time Frame: one month ] [ Designated as safety issue: Yes ]
    Perioperative complications include sternal wound infection (deep and superficial), bacteremia, pneumonia, and major cardiovascular events (acute myocardial infarction, congestive heart failure, and cardiac arrhythmias.


Estimated Enrollment: 100
Study Start Date: August 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Slow rewarming strategy
Slow rewarming strategy (0.24 degrees C/min)
 Other: Slow rewarming strategy
Rewarming rate:0.24 degrees C/min.
Active Comparator: Fast rewarming strategy
Fast rewarming strategy (0.5 degrees C/min)
 Other: Fast rewarming strategy
Rewarming rate:0.5 degrees C/min.

Detailed Description:

There have been many studies indicating that rewarming management plays an important role in cardiac surgery. The purpose of this study is to investigate the relationship between rewarming rate during cardiopulmonary bypass and clinical prognosis in patients undergoing cardiac surgery. Infants undergoing cardiac surgery with cardiopulmonary bypass are randomly assigned to either a slow rewarming strategy (0.24 degrees C/min) or a fast rewarming strategy (0.5 degrees C/min).

  Eligibility

Ages Eligible for Study:   up to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants who had underwent cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

  • Preoperative liver or kidney disease or dysfunction
  • Preoperative coagulation disorder
  • Palliative operation or a second operation
  • Above 3 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398709

Contacts
Contact: Chunhu Gu, MD guchunhu@fmmu.edu.cn

Locations
China, Shannxi
Xijing Hospital Not yet recruiting
Xi'an, Shannxi, China, 710032
Contact: Chunhu Gu, MD         guchunhu@fmmu.edu.cn    
Principal Investigator: Chunhu Gu, MD            
Principal Investigator: Yukun Cao, MD            
Sponsors and Collaborators
Xijing Hospital
Investigators
Study Chair: Dinghua Yi, MD Xijing Hospital
  More Information

No publications provided

Responsible Party: Chunhu Gu, Xijing Hospital
ClinicalTrials.gov Identifier: NCT01398709     History of Changes
Other Study ID Numbers: Guch-011
Study First Received: July 11, 2011
Last Updated: July 19, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
Cardiopulmonary Bypass
Prognosis
Cardiac Surgery
Rewarming Rate

ClinicalTrials.gov processed this record on May 16, 2013