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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 02; 53:178-187.CC

Abstract

OBJECTIVES

Test 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.

DESIGN

Multi-center randomized clinical trial.

SETTING

Pediatric ICUs at 35 academic hospitals.

PATIENTS

Children aged 2weeks to 17years receiving inotropic support and/or acute mechanical ventilation, excluding cardiac surgical patients.

INTERVENTIONS

Patients 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 RESULTS

The 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.

CONCLUSIONS

This 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.

Authors+Show Affiliations

Boston 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.Intermountain 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.The Children's Hospital of Philadelphia, University of Pennsylvania, 3401 Civic Center Blvd., Philadelphia, PA 19104, United States. Electronic address: srinivasan@email.chop.edu.Yale-New Haven Children's Hospital, Yale University, 1 Park St., New Haven, CT 06510, United States. Electronic address: vince.faustino@yale.edu.Children's Medical Center Dallas, University of Texas Southwestern, 1935 Medical District Dr., Dallas, TX 75235, United States. Electronic address: peter.luckett@childrens.com.University of Pennsylvania School of Nursing, University of Pennsylvania, 418 Curie Blvd., Philadelphia, PA 19104, United States. Electronic address: curley@nursing.upenn.edu.Boston 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.Boston Children's Hospital Department of Cardiology, Harvard Medical School, 300 Longwood Ave., Boston, MA 02115, United States. Electronic address: lisa.asaro@cardio.chboston.org.Boston 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.Boston Children's Hospital Department of Cardiology, Harvard Medical School, 300 Longwood Ave., Boston, MA 02115, United States. Electronic address: donna.duva@cardio.chboston.org.Boston 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.Boston Children's Hospital Department of Cardiology, Harvard Medical School, 300 Longwood Ave., Boston, MA 02115, United States. Electronic address: natalie.hasbani@childrens.harvard.edu.The Children's Hospital of Philadelphia, University of Pennsylvania, 3401 Civic Center Blvd., Philadelphia, PA 19104, United States. Electronic address: siskom@email.chop.edu.Boston 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.Boston 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.Boston Children's Hospital Department of Cardiology, Harvard Medical School, 300 Longwood Ave., Boston, MA 02115, United States. Electronic address: david.wypij@cardio.chboston.org.The Children's Hospital of Philadelphia, University of Pennsylvania, 3401 Civic Center Blvd., Philadelphia, PA 19104, United States. Electronic address: nadkarni@email.chop.edu.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

28042054

Citation

Agus, Michael Sd, et al. "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." Contemporary Clinical Trials, vol. 53, 2017, pp. 178-187.
Agus MS, Hirshberg E, Srinivasan V, et al. 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;53:178-187.
Agus, M. S., Hirshberg, E., Srinivasan, V., Faustino, E. V., Luckett, P. M., Curley, M. A., Alexander, J., Asaro, L. A., Coughlin-Wells, K., Duva, D., French, J., Hasbani, N., Sisko, M. T., Soto-Rivera, C. L., Steil, G., Wypij, D., & Nadkarni, V. M. (2017). 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. Contemporary Clinical Trials, 53, 178-187. https://doi.org/10.1016/j.cct.2016.12.023
Agus MS, et al. 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;53:178-187. PubMed PMID: 28042054.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Agus,Michael Sd, AU - Hirshberg,Ellie, AU - Srinivasan,Vijay, AU - Faustino,Edward Vincent, AU - Luckett,Peter M, AU - Curley,Martha Aq, AU - Alexander,Jamin, AU - Asaro,Lisa A, AU - Coughlin-Wells,Kerry, AU - Duva,Donna, AU - French,Jaclyn, AU - Hasbani,Natalie, AU - Sisko,Martha T, AU - Soto-Rivera,Carmen L, AU - Steil,Garry, AU - Wypij,David, AU - Nadkarni,Vinay M, Y1 - 2016/12/30/ PY - 2016/11/02/received PY - 2016/12/21/revised PY - 2016/12/24/accepted PY - 2017/1/4/pubmed PY - 2017/12/7/medline PY - 2017/1/3/entrez KW - Insulin therapy KW - Pediatric critical care KW - Randomized clinical trial KW - Stress hyperglycemia SP - 178 EP - 187 JF - Contemporary clinical trials JO - Contemp Clin Trials VL - 53 N2 - OBJECTIVES: Test 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. DESIGN: Multi-center randomized clinical trial. SETTING: Pediatric ICUs at 35 academic hospitals. PATIENTS: Children aged 2weeks to 17years receiving inotropic support and/or acute mechanical ventilation, excluding cardiac surgical patients. INTERVENTIONS: Patients 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 RESULTS: The 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. CONCLUSIONS: This 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. SN - 1559-2030 UR - https://www.unboundmedicine.com/medline/citation/28042054/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1551-7144(16)30398-6 DB - PRIME DP - Unbound Medicine ER -