Evidence map›Paper›PMID 28042054›Full record

Trial reportContemporary clinical trials2017

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.

Michael Sd Agus, Ellie Hirshberg, Vijay Srinivasan, Edward Vincent Faustino, Peter M Luckett, Martha Aq Curley, Jamin Alexander, Lisa A Asaro, Kerry Coughlin-Wells, Donna Duva and 7 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Contemporary clinical trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01565941 (Heart And Lung Failure - Pediatric INsulin Titration Trial), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01565941 phase3completednot on this map

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

TypeinterventionalSponsorBoston Children's HospitalRan2012 to 2018Enrolled713ConditionsHeart Failure, Respiratory FailureArmsInsulin
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Trial
  2. Trial
  3. 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.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2020
    Trial
  4. Tight Glycemic Control in Critically Ill Children.The New England journal of medicine · 2017
    Trial
  5. Article
  6. Observational
  7. Outcomes Associated With Multiple Organ Dysfunction Syndrome in Critically Ill Children With Hyperglycemia.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2019
    Article
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Michael Sd AgusBoston Children's Hospital Division of Medicine Critical Care, Harvard Medical School, 300 Longwood Ave., Boston, MA 02115, United States. Electronic address: michael.agus@childrens.harvard.edu.
Ellie HirshbergIntermountain Medical Center Division of Pulmonary and Critical Care, University of Utah, 100 Mario Capecchi Dr., Salt Lake City, UT 84132, United States. Electronic address: ellie.hirshberg@hsc.utah.edu.
Vijay SrinivasanThe Children's Hospital of Philadelphia, University of Pennsylvania, 3401 Civic Center Blvd., Philadelphia, PA 19104, United States. Electronic address: srinivasan@email.chop.edu.
Edward Vincent FaustinoYale-New Haven Children's Hospital, Yale University, 1 Park St., New Haven, CT 06510, United States. Electronic address: vince.faustino@yale.edu.
Peter M LuckettChildren's Medical Center Dallas, University of Texas Southwestern, 1935 Medical District Dr., Dallas, TX 75235, United States. Electronic address: peter.luckett@childrens.com.
Martha Aq CurleyUniversity of Pennsylvania School of Nursing, University of Pennsylvania, 418 Curie Blvd., Philadelphia, PA 19104, United States. Electronic address: curley@nursing.upenn.edu.
Jamin AlexanderBoston Children's Hospital Division of Medicine Critical Care, Harvard Medical School, 300 Longwood Ave., Boston, MA 02115, United States. Electronic address: jamin.alexander@childrens.harvard.edu.
Lisa A AsaroBoston Children's Hospital Department of Cardiology, Harvard Medical School, 300 Longwood Ave., Boston, MA 02115, United States. Electronic address: lisa.asaro@cardio.chboston.org.
Kerry Coughlin-WellsBoston Children's Hospital Division of Medicine Critical Care, Harvard Medical School, 300 Longwood Ave., Boston, MA 02115, United States. Electronic address: kerry.coughlin-wells@childrens.harvard.edu.
Donna DuvaBoston Children's Hospital Department of Cardiology, Harvard Medical School, 300 Longwood Ave., Boston, MA 02115, United States. Electronic address: donna.duva@cardio.chboston.org.
Jaclyn FrenchBoston Children's Hospital Division of Medicine Critical Care, Harvard Medical School, 300 Longwood Ave., Boston, MA 02115, United States. Electronic address: jaclyn.french@childrens.harvard.edu.
Natalie HasbaniBoston Children's Hospital Department of Cardiology, Harvard Medical School, 300 Longwood Ave., Boston, MA 02115, United States. Electronic address: natalie.hasbani@childrens.harvard.edu.
Martha T SiskoThe Children's Hospital of Philadelphia, University of Pennsylvania, 3401 Civic Center Blvd., Philadelphia, PA 19104, United States. Electronic address: siskom@email.chop.edu.
Carmen L Soto-RiveraBoston Children's Hospital Division of Medicine Critical Care, Harvard Medical School, 300 Longwood Ave., Boston, MA 02115, United States. Electronic address: carmen.soto@childrens.harvard.edu.
Garry SteilBoston Children's Hospital Division of Medicine Critical Care, Harvard Medical School, 300 Longwood Ave., Boston, MA 02115, United States. Electronic address: garry.steil@childrens.harvard.edu.
David WypijBoston Children's Hospital Department of Cardiology, Harvard Medical School, 300 Longwood Ave., Boston, MA 02115, United States. Electronic address: david.wypij@cardio.chboston.org.
Vinay M NadkarniThe Children's Hospital of Philadelphia, University of Pennsylvania, 3401 Civic Center Blvd., Philadelphia, PA 19104, United States. Electronic address: nadkarni@email.chop.edu.

Funding

HALF-PINT: Heart and Lung Failure - Pediatric INsulin Titration trial - CCCU01HL107681 · NHLBI · BOSTON CHILDREN'S HOSPITAL · PI AGUS, MICHAEL SD, NADKARNI, VINAY M · 2011 to 2016
$9.6M
HALF-PINT: Heart And Lung Failure - Pediatric INsulin Titration trial - DCCU01HL108028 · NHLBI · BOSTON CHILDREN'S HOSPITAL · PI WYPIJ, DAVID · 2011 to 2016
$2.9M
NHLBI NIH HHS U01 HL107681NHLBI NIH HHS U01 HL108028
6 · The paper itself

Abstract

objectivesTest whether hyperglycemic critically ill children with cardiovascular and/or respiratory failure experience more ICU-free days when assigned to tight glycemic control with a normoglycemic versus hyperglycemic blood glucose target range.

designMulti-center randomized clinical trial.

settingPediatric ICUs at 35 academic hospitals. PATIENTS: Children aged 2weeks to 17years receiving inotropic support and/or acute mechanical ventilation, excluding cardiac surgical patients.

interventionsPatients receive intravenous insulin titrated to either 80-110mg/dL (4.4-6.1mmol/L) or 150-180mg/dL (8.3-10.0mmol/L). The intervention begins upon confirmed hyperglycemia and ends when the patient meets study-defined ICU discharge criteria or after 28days. Continuous glucose monitoring, a minimum glucose infusion, and an explicit insulin infusion algorithm are deployed to achieve the BG targets while minimizing hypoglycemia risk. MEASUREMENTS AND MAIN

resultsThe primary outcome is ICU-free days (equivalent to 28-day hospital mortality-adjusted ICU length of stay). Secondary outcomes include 90-day hospital mortality, organ dysfunction scores, ventilator-free days, nosocomial infection rate, neurodevelopmental outcomes, and nursing workload. To detect an increase of 1.25 ICU-free days (corresponding to a 20% relative reduction in 28-day hospital mortality and a one-day reduction in ICU length of stay), 1414 patients are needed for 80% power using a two-sided 0.05 level test.

conclusionsThis trial tests whether hyperglycemic critically ill children randomized to 80-110mg/dL benefit more than those randomized to 150-180mg/dL. This study implements validated bedside support tools including continuous glucose monitoring and a computerized algorithm to enhance patient safety and ensure reproducible bedside decision-making in achieving glycemic control.

Indexed as

Academic Medical CentersAdolescentAlgorithmsBlood GlucoseCardiotonic AgentsChildChild, PreschoolCritical IllnessCross InfectionDisease ManagementFemaleHeart FailureHospital MortalityHumansHyperglycemiaHypoglycemic AgentsBlood GlucoseCardiotonic AgentsHypoglycemic AgentsInsulinInsulin therapyPediatric critical careRandomized clinical trialStress hyperglycemia

Identifiers

PMID28042054
PMCPMC5285511

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.