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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Xijing Hospital.
Recruitment status was:  Not yet recruiting
Information provided by:
Xijing Hospital Identifier:
First received: July 11, 2011
Last updated: July 19, 2011
Last verified: July 2011
The investigators sought to determine whether intensive insulin therapy can improve prognosis of infants undergoing cardiac surgery.

Condition Intervention Phase
Cardiac Surgery
Other: Intensive insulin therapy
Other: Conventional insulin therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Study of the Relationship Between Intensive Insulin Therapy and Clinical Prognosis in Infants Undergoing Cardiac Surgery

Resource links provided by NLM:

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: one year ]

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

Estimated Enrollment: 800
Study Start Date: August 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01398722

Contact: Chunhu Gu, MD

China, Shaanxi
Xijing Hospital Not yet recruiting
Xi'an, Shaanxi, China, 710032
Contact: Chunhu Gu, MD   
Principal Investigator: Chunhu Gu, MD         
Principal Investigator: Yukun Cao, MD         
Sponsors and Collaborators
Xijing Hospital
Study Chair: Dinhhua Yi, MD Xijing Hospital
  More Information

Responsible Party: Chunhu Gu, Xijing Hospital Identifier: NCT01398722     History of Changes
Other Study ID Numbers: Guch-012
Study First Received: July 11, 2011
Last Updated: July 19, 2011

Keywords provided by Xijing Hospital:
cardiac surgery
intensive insulin therapy

Additional relevant MeSH terms:
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 23, 2017