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

July 19, 2011 updated by: Xijing Hospital

Study of the Relationship Between Rewarming Rate During Cardiopulmonary Bypass and Clinical Prognosis in Infants Undergoing Cardiac Surgery

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shannxi
      • Xi'an, Shannxi, China, 710032
        • Xijing Hospital
        • Contact:
        • Principal Investigator:
          • Chunhu Gu, MD
        • Principal Investigator:
          • Yukun Cao, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
all cause mortality
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute renal failure
Time Frame: one month
one month
Respiratory failure
Time Frame: one month
one month
ICU and hospital length of stay, and ICU readmissions
Time Frame: one month
one month
Stroke and reversible ischemic neurologic deficit
Time Frame: one month
one month
Measures of inflammation
Time Frame: one month
Measures of inflammation (C-reactive protein, TNF-alpha; IL-6) and oxidative stress markers
one month
Biochemical markers of myocardial necrosis
Time Frame: one month
Biochemical markers of myocardial necrosis（troponin and creatine kinase MB）
one month
Perioperative complications
Time Frame: one month
Perioperative complications include sternal wound infection (deep and superficial), bacteremia, pneumonia, and major cardiovascular events (acute myocardial infarction, congestive heart failure, and cardiac arrhythmias.
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Anticipated)

September 1, 2012

Study Completion (Anticipated)

September 1, 2012

Study Registration Dates

First Submitted

July 11, 2011

First Submitted That Met QC Criteria

July 19, 2011

First Posted (Estimate)

July 20, 2011

Study Record Updates

Last Update Posted (Estimate)

July 20, 2011

Last Update Submitted That Met QC Criteria

July 19, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Guch-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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