Effect of Intensive Insulin Therapy on Clinical Prognosis... | NCT01398722

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

NCT01398722

Sponsor

Xijing Hospital

Status

Unknown status

Last Update Posted

Jul 20, 2011Estimated

Enrollment

800Estimated

Phase

Phase 2

Conditions

Cardiac Surgery

Interventions

Intensive insulin therapy
Conventional insulin therapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Jul 2012Estimated

Completion Date

Jul 2012Estimated

First Submitted Date

Jul 11, 2011

First Submission Date that Met QC Criteria

Jul 19, 2011

First Posted Date

Jul 20, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2011

Last Update Posted Date

Jul 20, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

800Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intensive insulin therapy	Active Comparator	Intensive insulin therapy(Blood glucose target: 110-150 mg/dL)	Other: Intensive insulin therapy
Conventional insulin therapy	Active Comparator	Conventional insulin therapy(Blood glucose target: 150-180 mg/dl)	Other: Conventional insulin therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intensive insulin therapy	Other	Titration of the IV insulin rate for glucose goal 110-150 mg/dL	Intensive insulin therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All cause mortality		one year

Secondary Outcomes

Measure	Description	Time Frame
Biochemical markers of myocardial injury(troponin and creatine kinase MB)		average 1 month during the hospitalization
Acute renal failure		average 1 month during the hospitalization

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

3 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chunhu Gu, MD	Contact			guchunhu@fmmu.edu.cn

Overall Officials

Name	Affiliation	Role
Dinhhua Yi, MD	Xijing Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xijing Hospital		Xi'an	Shaanxi	710032	China