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

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

The investigators sought to determine whether intensive insulin therapy can improve prognosis of infants undergoing cardiac surgery.

Study Overview

• Status: Unknown
• Conditions: Cardiac Surgery
• Intervention / Treatment: Other: Intensive insulin therapy; Other: Conventional insulin therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 800
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intensive insulin therapy; Intensive insulin therapy(Blood glucose target: 110-150 mg/dL)	Other: Intensive insulin therapy; Titration of the IV insulin rate for glucose goal 110-150 mg/dL
Active Comparator: Conventional insulin therapy; Conventional insulin therapy(Blood glucose target: 150-180 mg/dl)	Other: Conventional insulin therapy; Titration of the IV insulin rate for glucose goal 150-180 mg/dl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All cause mortality	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical markers of myocardial injury(troponin and creatine kinase MB)		average 1 month during the hospitalization
Acute renal failure		average 1 month during the hospitalization
Respiratory failure		average 1 month during the hospitalization
ICU and hospital length of stay, and ICU readmissions		average 1 month during the hospitalization
Stroke and reversible ischemic neurologic deficit		average 1 month during the hospitalization
Cardiac Index		average 1 month during the hospitalization
Inotropic Scores		average 1 month during the hospitalization
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

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Study Chair: Dinhhua Yi, MD, Xijing Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): July 1, 2012
• Study Completion (Anticipated): July 1, 2012

Study Registration Dates

• First Submitted: July 11, 2011
• First Submitted That Met QC Criteria: July 19, 2011
• First Posted (Estimate): July 20, 2011

Study Record Updates

• Last Update Posted (Estimate): July 20, 2011
• Last Update Submitted That Met QC Criteria: July 19, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: cardiac surgery; prognosis; intensive insulin therapy
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: Guch-012