Effect of Intensive Insulin Therapy on Clinical Prognosis of Infants Undergoing Cardiac Surgery

Cardiac Surgery Clinical Trial

Official title:

Study of the Relationship Between Intensive Insulin Therapy and Clinical Prognosis in Infants Undergoing Cardiac Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01398722
• Other study ID #: Guch-012
• 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

• Cardiac Surgery

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