Heart And Lung Failure - Pediatric INsulin Titration Trial



Status:Completed
Conditions:Cardiology, Pulmonary
Therapuetic Areas:Cardiology / Vascular Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any - 17
Updated:11/29/2018
Start Date:April 2012
End Date:February 2018

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Heart And Lung Failure - Pediatric INsulin Titration Trial (HALF-PINT)

Stress hyperglycemia, a state of abnormal metabolism with supra-normal blood glucose levels,
is often seen in critically ill patients. Tight glycemic control (TGC) was originally shown
to reduce morbidity and mortality in a landmark randomized clinical trial (RCT) of adult
critically ill surgical patients but has since come under intense scrutiny due to conflicting
results in recent adult trials. One pediatric RCT has been published to date that
demonstrated survival benefit but was complicated by an unacceptably high rate of severe
hypoglycemia. The Heart And Lung Failure - Pediatric INsulin Titration (HALF-PINT) trial is a
multi-center, randomized clinical treatment trial comparing two ranges of glucose control in
hyperglycemic critically ill children with heart and/or lung failure. Both target ranges of
glucose control fall within the range of "usual care" for critically ill children managed in
pediatric intensive care units.

The purpose of the study is to determine the comparative effectiveness of tight glycemic
control to a target range of 80-110 mg/dL (TGC-1, 4.4-6.1 mmol/L) vs. a target range of
150-180 mg/dL (TGC-2, 8.3-10.0 mmol/L) on hospital mortality and intensive care unit (ICU)
length of stay (LOS) in hyperglycemic critically ill children with cardiovascular and/or
respiratory failure. This will be accomplished using an explicit insulin titration algorithm
and continuous glucose monitoring to safely achieve these glucose targets. Both groups will
receive identical standardized intravenous glucose at an age-appropriate rate in order to
provide basal calories and mitigate hypoglycemia. Insulin infusions will be titrated with an
explicit algorithm combined with continuous glucose monitoring using a protocol that has been
safely implemented in 490 critically ill infants and children.


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)

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
We found this trial at
34
sites
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Michael Agus, MD
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Ann Arbor, MI 48109Bus: -
Ann Arbor, Michigan 48109
Principal Investigator: Heidi Flori, MD
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5721 S. Maryland Avenue
Chicago, Illinois 60637
Principal Investigator: Neethi Pinto, MD
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Chicago, IL
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747 52nd St
Oakland, California 94609
(510) 428-3000
Principal Investigator: Natalie Cvijanovich, MD
Children's Hospital and Research Center Oakland For nearly 100 years, Children's Hospital & Research Center...
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Principal Investigator: Adam Schwarz, MD
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Vijay Srinivasan, MD
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Principal Investigator: Nga Pham, MD
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
Principal Investigator: Dayanand Bagdure, MD
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Bronx, New York 10467
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Buffalo, New York 14222
Principal Investigator: Amanda Hassinger, MD
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Chicago, Illinois 60611
Principal Investigator: Lauren Marsillio, MD
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Cincinnati, Ohio 45229
Principal Investigator: Ranjit Chima, MD
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7777 Forest Lane
Dallas, Texas 75230
Principal Investigator: Gokul K. Bysani, MD
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1935 Medical District Dr
Dallas, Texas 75235
(214) 456-7000
Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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Durham, North Carolina 27705
Principal Investigator: Kyle Rehder, MD
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Hershey, Pennsylvania 17033
Principal Investigator: Neal Thomas, MD
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Hershey, PA
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Sholeen Nett, MD
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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Long Beach, California 90806
Principal Investigator: Christopher Babbitt, MD
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Long Beach, CA
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Los Angeles, California 90027
Principal Investigator: Christopher Newth, MD
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Los Angeles, California 90095
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
Principal Investigator: Janice E. Sullivan, MD
University of Louisville The University of Louisville is a state supported research university located in...
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Melbourne, Victoria 3051
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New Haven, Connecticut 06511
Principal Investigator: Sarah Kandil, MD
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New Hyde Park, New York 11040
Principal Investigator: James B. Schneider, MD
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New York, New York 10032
Principal Investigator: Katherine Biagas, MD
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Oklahoma City, Oklahoma 73104
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Saint Louis, Missouri 63110
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Salt Lake City, Utah 84143
Principal Investigator: Ellie Hirshberg, MD
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San Francisco, California 94143
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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Valhalla, New York 10595
Principal Investigator: Simon Li, MD
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Wilmington, Delaware 19803
Principal Investigator: Shirley Viteri, MD
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