Tight Glycemic Control With Intensive Insulin Therapy in PICU

March 8, 2022 updated by: Greet Van den Berghe

KULeuven Intensive Insulin Study in Pediatric Intensive Care Patients

In a previous study, the investigators showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality in adult intensive care patients. Whether this intervention also improves prognosis of pediatric intensive care patients remains unknown. The current prospective, randomized, controlled study will asses the impact of intensive insulin therapy on outcome of patients in a pediatric intensive care unit. On admission patients will be randomly assigned to either strict normalization of blood glucose according age adjusted values or the conventional approach, in which insulin infusion is initiated only when blood glucose exceeds 215 mg/dl to maintain blood glucose levels between 180-200 mg/dl.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Study type: Interventional study

Study design: single centre, prospective, randomized, active control, parallel assignment, efficacy study

Study Type

Interventional

Enrollment (Actual)

700

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Dep Intensive Care Medicine University Hospital Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children admitted to the pediatric intensive care unit and anticipated to require intensive care for at least 24 hours

Exclusion Criteria:

  • Expected stay < 24 hours
  • Therapy restriction upon admission
  • No informed consent
  • Other study enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
conventional insulin therapy (using Actrapid IV)
Drug: conventional insulin therapy (Actrapid IV only for excessive hyperglycemia)
conventional insulin therapy (Actrapid IV in continuous infusion only to treat blood glucose levels exceeding 220 mg/dl)
Other Names:
  • Actrapid IV only for excessive hyperglycemia
Experimental: B
intensive insulin therapy (using actrapid IV)
Drug: intensive insulin therapy (Actrapid IV to normoglycemia)
intensive insulin therapy (Actrapid IV in continuous infusion to age-dependent normoglycemia)
Other Names:
  • Actrapid IV to normoglycemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of inflammation
Time Frame: during ICU stay to day 5
during ICU stay to day 5
duration of dependency on intensive care (days in ICU)
Time Frame: time in ICU
time in ICU

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration mechanical ventilation
Time Frame: during time in ICU
during time in ICU
Organ failure/need for organ support
Time Frame: during time in ICU
during time in ICU
mortality (safety endpoint)
Time Frame: during time in ICU
during time in ICU
long-term follow-up study : focus on neurocognitive development (ethical approval granted)
Time Frame: 3 years (+/- 6 months) after randomization
3 years (+/- 6 months) after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Greet Van den Berghe

Investigators

  • Study Director: Greet Van den Berghe, MD,PhD, Catholic University Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

February 1, 2008

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

September 19, 2005

First Submitted That Met QC Criteria

September 21, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Actual)

March 10, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PICU-insulin study
  • NCT00214916

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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