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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01398722
Other study ID # Guch-012
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received July 11, 2011
Last updated July 19, 2011
Start date August 2011
Est. completion date July 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 investigators sought to determine whether intensive insulin therapy can improve prognosis of infants undergoing cardiac surgery.


Description:

Previous studies showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality of surgical and medical intensive care patients. Blood sugar control with intravenous insulin may improve prognosis of patients undergoing cardiac surgery. It is not clear what the best insulin regimen is or what is the best blood sugar target in these patients. So far, most of researches have focused on adult patients but little on infants. The current prospective, randomized, controlled study will assess the impact of intensive insulin therapy on the outcome of infants undergoing cardiac surgery. On admission, patients will be randomly assigned to either strict normalization of blood glucose ( 110-150 mg/dl) with intensive insulin therapy or the conventional approach, in which blood glucose levels are maintained between 150 and 180 mg/dl.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 800
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group N/A to 3 Years
Eligibility Inclusion Criteria:

- Infants underwent cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

- Therapy restricted upon admission

- Preoperative liver or kidney disease or dysfunction

- Preoperative coagulation disorder

- Palliative operation or a second operation

- Type 1 diabetes

- Type 2 diabetes

Study Design

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


Related Conditions & MeSH terms


Intervention

Other:
Intensive insulin therapy
Titration of the IV insulin rate for glucose goal 110-150 mg/dL
Conventional insulin therapy
Titration of the IV insulin rate for glucose goal 150-180 mg/dl

Locations

Country Name City State
China Xijing Hospital Xi'an Shaanxi

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 Yes
Secondary Biochemical markers of myocardial injury(troponin and creatine kinase MB) average 1 month during the hospitalization Yes
Secondary Acute renal failure average 1 month during the hospitalization Yes
Secondary Respiratory failure average 1 month during the hospitalization Yes
Secondary ICU and hospital length of stay, and ICU readmissions average 1 month during the hospitalization Yes
Secondary Stroke and reversible ischemic neurologic deficit average 1 month during the hospitalization Yes
Secondary Cardiac Index average 1 month during the hospitalization Yes
Secondary Inotropic Scores average 1 month during the hospitalization Yes
Secondary Perioperative complications Perioperative complications including sternal wound infection (deep and superficial), bacteremia, pneumonia, and major cardiovascular events (acute myocardial infarction, congestive heart failure, and cardiac arrhythmias average 1 month during the hospitalization Yes
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