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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01398722

Enrollment

800

Registered

2011-07-20

Start date

2011-08-31

Completion date

2012-07-31

Last updated

2011-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery

Keywords

cardiac surgery, prognosis, intensive insulin therapy

Brief summary

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

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.

Interventions

OTHERIntensive insulin therapy

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

OTHERConventional insulin therapy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

No minimum to 3 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
All cause mortality	one year

Secondary

Measure	Time frame	Description
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	—
Biochemical markers of myocardial injury(troponin and creatine kinase MB)	average 1 month during the hospitalization	—
Cardiac Index	average 1 month during the hospitalization	—
Inotropic Scores	average 1 month during the hospitalization	—
Perioperative complications	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
Stroke and reversible ischemic neurologic deficit	average 1 month during the hospitalization	—

Countries

China

Contacts

Primary ContactChunhu Gu, MD

guchunhu@fmmu.edu.cn

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026