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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Intensive insulin therapy

Intensive insulin therapy(Blood glucose target: 110-150 mg/dL)

Group Type ACTIVE_COMPARATOR

Intensive insulin therapy

Intervention Type OTHER

Titration of the IV insulin rate for glucose goal 110-150 mg/dL

Conventional insulin therapy

Conventional insulin therapy(Blood glucose target: 150-180 mg/dl)

Group Type ACTIVE_COMPARATOR

Conventional insulin therapy

Intervention Type OTHER

Titration of the IV insulin rate for glucose goal 150-180 mg/dl

Interventions

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Intensive insulin therapy

Titration of the IV insulin rate for glucose goal 110-150 mg/dL

Intervention Type OTHER

Conventional insulin therapy

Titration of the IV insulin rate for glucose goal 150-180 mg/dl

Intervention Type OTHER

Eligibility Criteria

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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

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No