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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01565941




Registration number
NCT01565941
Ethics application status
Date submitted
21/03/2012
Date registered
29/03/2012

Titles & IDs
Public title
Heart And Lung Failure - Pediatric INsulin Titration Trial
Scientific title
Heart And Lung Failure - Pediatric INsulin Titration Trial (HALF-PINT)
Secondary ID [1] 0 0
U01HL107681
Secondary ID [2] 0 0
IRB-P00002310
Universal Trial Number (UTN)
Trial acronym
HALF-PINT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Respiratory Failure 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Insulin
Treatment: Drugs - Insulin

Active comparator: Tight Glycemic Control 1 (TGC-1) - Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.

Active comparator: Tight Glycemic Control 2 (TGC-2) - Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.


Treatment: Drugs: Insulin
IV insulin titration to target a blood glucose of 80-110 mg/dL

Treatment: Drugs: Insulin
IV insulin titration to target a blood glucose of 150-180 mg/dL
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
ICU-Free Days
Timepoint [1] 0 0
Study day 28
Secondary outcome [1] 0 0
90-day Hospital Mortality
Timepoint [1] 0 0
90 days after randomization
Secondary outcome [2] 0 0
28-day Hospital Mortality
Timepoint [2] 0 0
28 days after randomization
Secondary outcome [3] 0 0
Accumulation of Multiple Organ Dysfunction Syndrome (MODS)
Timepoint [3] 0 0
28 days after randomization
Secondary outcome [4] 0 0
Ventilator-Free Days
Timepoint [4] 0 0
28 days following randomization
Secondary outcome [5] 0 0
Developmental Neurobehavioral Outcomes: VABS-II Composite
Timepoint [5] 0 0
One year after ICU course
Secondary outcome [6] 0 0
Participants With Device-Related or Non-Device Related Nosocomial Infection
Timepoint [6] 0 0
Up to 48 hours after ICU discharge
Secondary outcome [7] 0 0
Incidence of Catheter-Associated Bloodstream Infection
Timepoint [7] 0 0
Up to 48 hours after ICU discharge
Secondary outcome [8] 0 0
Incidence of Catheter-Associated Urinary Tract Infection
Timepoint [8] 0 0
Up to 48 hours after ICU discharge
Secondary outcome [9] 0 0
Incidence of Ventilator-Associated Pneumonia
Timepoint [9] 0 0
Up to 48 hours after ICU discharge
Secondary outcome [10] 0 0
Incidence of Wound Infection Incidence of Wound Infection
Timepoint [10] 0 0
Up to 48 hours after ICU discharge
Secondary outcome [11] 0 0
Participants With Severe Hypoglycemia (<40 mg/dL), Unrelated to Insulin Infusion (Insulin Algorithm Safety)
Timepoint [11] 0 0
Participants will be followed for the duration of ICU stay, an expected average of 8 days
Secondary outcome [12] 0 0
Participants With Severe Hypoglycemia (<40 mg/dL), Related to Insulin Infusion (Insulin Algorithm Safety)
Timepoint [12] 0 0
Participants will be followed for the duration of ICU stay, an expected average of 8 days
Secondary outcome [13] 0 0
Participants With Any Hypoglycemia (<60 mg/dL), Unrelated to Insulin Infusion (Insulin Algorithm Safety)
Timepoint [13] 0 0
Participants will be followed for the duration of ICU stay, an expected average of 8 days
Secondary outcome [14] 0 0
Participants With Any Hypoglycemia (<60 mg/dL), Related to Insulin Infusion (Insulin Algorithm Safety)
Timepoint [14] 0 0
Participants will be followed for the duration of ICU stay, an expected average of 8 days
Secondary outcome [15] 0 0
Participants With Hypokalemia (<2.5 mmol/L)
Timepoint [15] 0 0
Participants will be followed for the duration of ICU stay, an expected average of 8 days
Secondary outcome [16] 0 0
Nursing Workload: SWAT (Subjective Workload Assessment Technique) Instrument
Timepoint [16] 0 0
One nursing shift caring for patient on TGC, at anytime during the patient's hospital stay through the tenth nursing shift for the patient. Shift determined randomly by the last digit of the study ID number, 0-9 (0=shift 10, 1=shift 1, 2=shift 2, etc.).
Secondary outcome [17] 0 0
Nursing Workload: NASA-TLX (National Aeronautics and Space Administration - Task Load Index) Instrument
Timepoint [17] 0 0
One nursing shift caring for patient on TGC, at anytime during the patient's hospital stay through the tenth nursing shift for the patient. Shift determined randomly by the last digit of the study ID number, 0-9 (0=shift 10, 1=shift 1, 2=shift 2, etc.).
Secondary outcome [18] 0 0
Insulin Algorithm Performance: Time to the Target Range
Timepoint [18] 0 0
Until study discharge, up to 28 days following randomization
Secondary outcome [19] 0 0
Insulin Algorithm Performance: Time in the Target Range
Timepoint [19] 0 0
Until study discharge, up to 28 days following randomization
Secondary outcome [20] 0 0
Insulin Algorithm Performance: Time-Weighted Glucose Average
Timepoint [20] 0 0
Until study discharge, up to 28 days following randomization

Eligibility
Key inclusion criteria
* Cardiovascular failure and/or respiratory failure:

1. Cardiovascular Failure: Dopamine or dobutamine > 5 mcg/kg/min, or any dose of epinephrine, norepinephrine, phenylephrine, milrinone or vasopressin if used to treat hypotension.
2. Respiratory Failure: Acute mechanical ventilation via endotracheal tube or tracheostomy.
* Age >= 2 weeks and corrected gestational age >= 42 weeks
* Age < 18 years (has not yet had 18th birthday)
Minimum age
2 Weeks
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* No longer has cardiovascular or respiratory failure (as defined in inclusion criterion 1), or is expected to be extubated in the next 24 hours
* Expected to remain in ICU < 24 hours
* Previously randomized in HALF-PINT
* Enrolled in a competing clinical trial
* Family/team decision to limit/redirect from aggressive ICU technological support
* Chronic ventilator dependence prior to ICU admission (non-invasive ventilation and ventilation via tracheostomy overnight or during sleep are acceptable)
* Type 1 or 2 diabetes
* Cardiac surgery within prior 2 months or during/planned for this hospitalization (extra-corporeal life support or non-cardiac surgery is acceptable)
* Diffuse skin disease that does not allow securement of a subcutaneous sensor
* Therapeutic plan to remain intubated for >28 days
* Receiving therapeutic cooling with targeted body temperatures <34 degrees Celsius
* Current or planned ketogenic diet
* Ward of the state
* Pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2018
Sample size
Target
Accrual to date
Final
713
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Children's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3052 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Delaware
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Hampshire
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oklahoma
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Other
Name
Boston Children's Hospital
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Heart, Lung, and Blood Institute (NHLBI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael SD Agus, MD
Address 0 0
Boston Children's Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01565941