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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01398709

Enrollment

100

Registered

2011-07-20

Start date

2011-08-31

Completion date

2012-09-30

Last updated

2011-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Cardiopulmonary Bypass, Rewarming Rate

Keywords

Cardiopulmonary Bypass, Prognosis, Cardiac Surgery, Rewarming Rate

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).

Interventions

OTHERFast rewarming strategy

Rewarming rate:0.5 degrees C/min.

OTHERSlow rewarming strategy

Rewarming rate:0.24 degrees C/min.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

No minimum to 3 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
all cause mortality	one year

Secondary

Measure	Time frame	Description
Respiratory failure	one month	—
ICU and hospital length of stay, and ICU readmissions	one month	—
Stroke and reversible ischemic neurologic deficit	one month	—
Acute renal failure	one month	—
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.
Measures of inflammation	one month	Measures of inflammation (C-reactive protein, TNF-alpha; IL-6) and oxidative stress markers

Countries

China

Contacts

Primary ContactChunhu Gu, MD

guchunhu@fmmu.edu.cn

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026