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

Phase 2

• Conditions: Cardiac Surgery; Cardiopulmonary Bypass; Rewarming Rate
• Interventions: Other: Slow rewarming strategy; Other: Fast rewarming strategy

• Registration Number: NCT01398709
• Lead Sponsor: Xijing Hospital

Brief Summary

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

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 Timeline

• Status Verified: 2011-07
• Study First Submitted: 2011-07-11
• Study First Submitted QC: 2011-07-19
• Last Update Submitted: 2011-07-19
• Study First Posted: 2011-07-20
• Last Update Posted: 2011-07-20
• Study Start: 2011-08
• Primary Completion: 2012-09
• Study Completion: 2012-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Slow rewarming strategy	Slow rewarming strategy	Slow rewarming strategy (0.24 degrees C/min)
Fast rewarming strategy	Fast rewarming strategy	Fast rewarming strategy (0.5 degrees C/min)

Primary Outcome Measures

Name	Time	Method
all cause mortality	one year

Secondary Outcome Measures

Name	Time	Method
Acute renal failure	one month
Respiratory failure	one month
ICU and hospital length of stay, and ICU readmissions	one month
Stroke and reversible ischemic neurologic deficit	one month
Measures of inflammation	one month	Measures of inflammation (C-reactive protein, TNF-alpha; IL-6) and oxidative stress markers
Biochemical markers of myocardial necrosis	one month	Biochemical markers of myocardial necrosis（troponin and creatine kinase MB）
Perioperative complications	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.

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shannxi, China