ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01398722
Recruitment Status : Unknown
Verified July 2011 by Xijing Hospital.
Recruitment status was:  Not yet recruiting
First Posted : July 20, 2011
Last Update Posted : July 20, 2011
Sponsor:
Information provided by:
Xijing Hospital

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

Condition or disease Intervention/treatment Phase
Cardiac Surgery Other: Intensive insulin therapy Other: Conventional insulin therapy Phase 2

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  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Study of the Relationship Between Intensive Insulin Therapy and Clinical Prognosis in Infants Undergoing Cardiac Surgery
Study Start Date : August 2011
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

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




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

Secondary Outcome Measures :
  1. Biochemical markers of myocardial injury(troponin and creatine kinase MB) [ Time Frame: average 1 month during the hospitalization ]
  2. Acute renal failure [ Time Frame: average 1 month during the hospitalization ]
  3. Respiratory failure [ Time Frame: average 1 month during the hospitalization ]
  4. ICU and hospital length of stay, and ICU readmissions [ Time Frame: average 1 month during the hospitalization ]
  5. Stroke and reversible ischemic neurologic deficit [ Time Frame: average 1 month during the hospitalization ]
  6. Cardiac Index [ Time Frame: average 1 month during the hospitalization ]
  7. Inotropic Scores [ Time Frame: average 1 month during the hospitalization ]
  8. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01398722


Contacts
Contact: Chunhu Gu, MD guchunhu@fmmu.edu.cn

Locations
China, Shaanxi
Xijing Hospital Not yet recruiting
Xi'an, Shaanxi, China, 710032
Contact: Chunhu Gu, MD       guchunhu@fmmu.edu.cn   
Principal Investigator: Chunhu Gu, MD         
Principal Investigator: Yukun Cao, MD         
Sponsors and Collaborators
Xijing Hospital
Investigators
Study Chair: Dinhhua Yi, MD Xijing Hospital

Responsible Party: Chunhu Gu, Xijing Hospital
ClinicalTrials.gov Identifier: NCT01398722     History of Changes
Other Study ID Numbers: Guch-012
First Posted: July 20, 2011    Key Record Dates
Last Update Posted: July 20, 2011
Last Verified: July 2011

Keywords provided by Xijing Hospital:
cardiac surgery
prognosis
intensive insulin therapy

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs