NCT01398722

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
12 days until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

July 20, 2011

Status Verified

July 1, 2011

Enrollment Period

11 months

First QC Date

July 11, 2011

Last Update Submit

July 19, 2011

Conditions

Cardiac Surgery

Keywords

cardiac surgeryprognosisintensive insulin therapy

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    one year

Secondary Outcomes (8)

  • 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

  • Respiratory failure

    average 1 month during the hospitalization

  • ICU and hospital length of stay, and ICU readmissions

    average 1 month during the hospitalization

  • Stroke and reversible ischemic neurologic deficit

    average 1 month during the hospitalization

  • +3 more secondary outcomes

Study Arms (2)

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

Intensive insulin therapyOTHER

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

Intensive insulin therapy
Conventional insulin therapyOTHER

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

Conventional insulin therapy

Eligibility Criteria

AgeUp to 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants underwent cardiac surgery with cardiopulmonary bypass

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Study Officials

  • Dinhhua Yi, MD

    Xijing Hospital

    STUDY CHAIR

Central Study Contacts

Chunhu Gu, MD

CONTACT

guchunhu@fmmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 11, 2011

First Posted

July 20, 2011

Study Start

August 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

July 20, 2011

Record last verified: 2011-07

Locations

CN(1)