Heart And Lung Failure - Pediatric INsulin Titration Trial
NCT ID: NCT01565941
Last Updated: 2022-07-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
713 participants
INTERVENTIONAL
2012-04-30
2018-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Insulin
IV insulin titration to target a blood glucose of 80-110 mg/dL
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.
Insulin
IV insulin titration to target a blood glucose of 150-180 mg/dL
Interventions
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Insulin
IV insulin titration to target a blood glucose of 80-110 mg/dL
Insulin
IV insulin titration to target a blood glucose of 150-180 mg/dL
Eligibility Criteria
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Inclusion Criteria
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
* 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
2 Weeks
17 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Boston Children's Hospital
OTHER
Responsible Party
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Michael Agus
Associate Professor of Pediatrics, Harvard Medical School
Principal Investigators
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Michael SD Agus, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Vinay M Nadkarni, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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Miller Children's Hospital Long Beach
Long Beach, California, United States
Children's Hospital of Los Angelos
Los Angeles, California, United States
Mattel Children's Hospital
Los Angeles, California, United States
Children's Hospital & Research Center of Oakland
Oakland, California, United States
Children's Hospital of Orange County
Orange, California, United States
UCSF Benioff Children's Hospital
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Yale-New Haven Children's Hospital
New Haven, Connecticut, United States
Nemours/A.I DuPont Hospital for Children
Wilmington, Delaware, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital pf Chicago
Chicago, Illinois, United States
University of Chicago Comer Children's Hospital
Chicago, Illinois, United States
University of Louisville
Louisville, Kentucky, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Women and Children's Hospital of Buffalo
Buffalo, New York, United States
North Shore LIJ Cohen Children's Medical Center
New Hyde Park, New York, United States
Morgan Stanley Children's Hospital of New York
New York, New York, United States
The Children's Hospital at Montefiore
The Bronx, New York, United States
Westchester Medical Center
Valhalla, New York, United States
Duke Children's Hospital and Medical Center
Durham, North Carolina, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
The Children's Hospital at OU Medical Center
Oklahoma City, Oklahoma, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Medical City Children's Dallas
Dallas, Texas, United States
Children's Medical Center Dallas
Dallas, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
The Royal Children's Hospital
Melbourne, Victoria, Australia
CHU Sainte-Justine
Montreal, Quebec, Canada
Countries
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References
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Agus MS, Hirshberg E, Srinivasan V, Faustino EV, Luckett PM, Curley MA, Alexander J, Asaro LA, Coughlin-Wells K, Duva D, French J, Hasbani N, Sisko MT, Soto-Rivera CL, Steil G, Wypij D, Nadkarni VM. Design and rationale of Heart and Lung Failure - Pediatric INsulin Titration Trial (HALF-PINT): A randomized clinical trial of tight glycemic control in hyperglycemic critically ill children. Contemp Clin Trials. 2017 Feb;53:178-187. doi: 10.1016/j.cct.2016.12.023. Epub 2016 Dec 30.
LaRovere KL, Asaro LA, Coughlin-Wells K, Nadkarni VM, Agus MSD; Heart and Lung Failure-Pediatric Insulin Titration (HALF-PINT) Study Investigators. Blood Glucose Range for Hyperglycemic PICU Children With Primary Neurologic Diagnoses: Analysis of the Heart and Lung Failure-Pediatric Insulin Titration (HALF-PINT) Trial. Pediatr Crit Care Med. 2025 Apr 1;26(4):e432-e446. doi: 10.1097/PCC.0000000000003689. Epub 2025 Feb 5.
Yang JO, Zinter MS, Pellegrini M, Wong MY, Gala K, Markovic D, Nadel B, Peng K, Do N, Mangul S, Nadkarni VM, Karlsberg A, Deshpande D, Butte MJ, Asaro L, Agus M, Sapru A; Study Site Investigators for CAF-PINT. Whole blood transcriptomics identifies subclasses of pediatric septic shock. Crit Care. 2023 Dec 8;27(1):486. doi: 10.1186/s13054-023-04689-y.
Yang JO, Zinter MS, Pellegrini M, Wong MY, Gala K, Markovic D, Nadel B, Peng K, Do N, Mangul S, Nadkarni VM, Karlsberg A, Deshpande D, Butte MJ, Asaro L, Agus M, Sapru A. Whole Blood Transcriptomics Identifies Subclasses of Pediatric Septic Shock. Res Sq [Preprint]. 2023 Aug 28:rs.3.rs-3267057. doi: 10.21203/rs.3.rs-3267057/v1.
Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.
Zinter MS, Markovic D, Asaro LA, Nadkarni VM, McQuillen PS, Sinha P, Matthay MA, Jeschke MG, Agus MSD, Sapru A; CAF-PINT Investigators of the PALISI Network. Tight Glycemic Control, Inflammation, and the ICU: Evidence for Heterogeneous Treatment Effects in Two Randomized Controlled Trials. Am J Respir Crit Care Med. 2023 Apr 1;207(7):945-949. doi: 10.1164/rccm.202210-1988LE. No abstract available.
Hirshberg EL, Alexander JL, Asaro LA, Coughlin-Wells K, Steil GM, Spear D, Stone C, Nadkarni VM, Agus MSD; HALF-PINT Study Investigators. Performance of an Electronic Decision Support System as a Therapeutic Intervention During a Multicenter PICU Clinical Trial: Heart and Lung Failure-Pediatric Insulin Titration Trial (HALF-PINT). Chest. 2021 Sep;160(3):919-928. doi: 10.1016/j.chest.2021.04.049. Epub 2021 Apr 29.
LaMarra D, French J, Bailey C, Sisko MT, Coughlin-Wells K, Agus MSD, Srinivasan V, Nadkarni VM; Heart And Lung Failure-Pediatric INsulin Titration (HALF-PINT) Study Investigators. A Novel Framework Using Remote Telesimulation With Standardized Parents to Improve Research Staff Preparedness for Informed Consent in Pediatric Critical Care Research. Pediatr Crit Care Med. 2020 Dec;21(12):e1042-e1051. doi: 10.1097/PCC.0000000000002484.
Biagas KV, Hinton VJ, Hasbani NR, Luckett PM, Wypij D, Nadkarni VM, Agus MSD; HALF-PINT trial study investigators; PALISI Network. Long-Term Neurobehavioral and Quality of Life Outcomes of Critically Ill Children after Glycemic Control. J Pediatr. 2020 Mar;218:57-63.e5. doi: 10.1016/j.jpeds.2019.10.055. Epub 2020 Jan 3.
Srinivasan V, Hasbani NR, Mehta NM, Irving SY, Kandil SB, Allen HC, Typpo KV, Cvijanovich NZ, Faustino EVS, Wypij D, Agus MSD, Nadkarni VM; Heart and Lung Failure-Pediatric Insulin Titration (HALF-PINT) Study Investigators. Early Enteral Nutrition Is Associated With Improved Clinical Outcomes in Critically Ill Children: A Secondary Analysis of Nutrition Support in the Heart and Lung Failure-Pediatric Insulin Titration Trial. Pediatr Crit Care Med. 2020 Mar;21(3):213-221. doi: 10.1097/PCC.0000000000002135.
Agus MS, Wypij D, Hirshberg EL, Srinivasan V, Faustino EV, Luckett PM, Alexander JL, Asaro LA, Curley MA, Steil GM, Nadkarni VM; HALF-PINT Study Investigators and the PALISI Network. Tight Glycemic Control in Critically Ill Children. N Engl J Med. 2017 Feb 23;376(8):729-741. doi: 10.1056/NEJMoa1612348. Epub 2017 Jan 24.
Other Identifiers
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IRB-P00002310
Identifier Type: -
Identifier Source: org_study_id
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