Effect of Intensive Insulin Therapy on Clinical Prognosis of Infants Undergoing Cardiac Surgery
This study is not yet open for participant recruitment.
Verified July 2011 by Xijing Hospital
Sponsor:
Xijing Hospital
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01398722
First received: July 11, 2011
Last updated: July 19, 2011
Last verified: July 2011
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Purpose
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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Biochemical markers of myocardial injury(troponin and creatine kinase MB) [ Time Frame: average 1 month during the hospitalization ] [ Designated as safety issue: Yes ]
- Acute renal failure [ Time Frame: average 1 month during the hospitalization ] [ Designated as safety issue: Yes ]
- Respiratory failure [ Time Frame: average 1 month during the hospitalization ] [ Designated as safety issue: Yes ]
- ICU and hospital length of stay, and ICU readmissions [ Time Frame: average 1 month during the hospitalization ] [ Designated as safety issue: Yes ]
- Stroke and reversible ischemic neurologic deficit [ Time Frame: average 1 month during the hospitalization ] [ Designated as safety issue: Yes ]
- Cardiac Index [ Time Frame: average 1 month during the hospitalization ] [ Designated as safety issue: Yes ]
- Inotropic Scores [ Time Frame: average 1 month during the hospitalization ] [ Designated as safety issue: Yes ]
- Perioperative complications [ Time Frame: average 1 month during the hospitalization ] [ Designated as safety issue: Yes ]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.
Eligibility| Ages Eligible for Study: | up to 3 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
No publications provided
| Responsible Party: | Chunhu Gu, Xijing Hospital |
| ClinicalTrials.gov Identifier: | NCT01398722 History of Changes |
| Other Study ID Numbers: | Guch-012 |
| Study First Received: | July 11, 2011 |
| Last Updated: | July 19, 2011 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Xijing Hospital:
|
cardiac surgery prognosis intensive insulin therapy |
Additional relevant MeSH terms:
|
Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013