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

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01398709
• Other study ID #: Guch-011
• Status: Not yet recruiting
• Phase: Phase 2
• First received: July 11, 2011
• Last updated: July 19, 2011
• Start date: August 2011
• Est. completion date: September 2012

Study information

• Verified date: July 2011
• Source: Xijing Hospital
• Contact: Chunhu Gu, MD
• Email: guchunhu[@]fmmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Cardiac Surgery
• Cardiopulmonary Bypass
• Rewarming Rate

Intervention

Other:
• Slow rewarming strategy
Rewarming rate:0.24 degrees C/min.
• Fast rewarming strategy
Rewarming rate:0.5 degrees C/min.

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shannxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		one year	No
Secondary	Acute renal failure		one month	Yes
Secondary	Respiratory failure		one month	Yes
Secondary	ICU and hospital length of stay, and ICU readmissions		one month	Yes
Secondary	Stroke and reversible ischemic neurologic deficit		one month	Yes
Secondary	Measures of inflammation	Measures of inflammation (C-reactive protein, TNF-alpha; IL-6) and oxidative stress markers	one month	Yes
Secondary	Biochemical markers of myocardial necrosis	Biochemical markers of myocardial necrosis(troponin and creatine kinase MB)	one month	Yes
Secondary	Perioperative complications	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	Yes