Heart And Lung Failure - Pediatric INsulin Titration Trial

Description

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 >900 critically ill infants and children.

Study Start Date

March 2012

Estimated Completion Date

October 2018

Interventions

  • Drug: Insulin

Specialties

  • Cardiology: Heart Failure
  • Pediatrics: Clinical Pharmacology,Pediatric Cardiology,Pediatric Endocrinology,Pediatric Pulmonology
  • Pulmonology: Critical Care,Peds Pulmonology
  • Pharmacy: Drug Trials

MeSH Terms

  • Heart Failure
  • Insulin
  • Respiratory Insufficiency

Study ID

Children's Hospital Boston -- IRB-P00002310

Status

Unknown

Trial ID

NCT01565941

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

1414

Sponsor

Children's Hospital Boston

Inclusion Criteria

  • Cardiovascular failure and/or respiratory failure: 1. Cardiovascular Failure: Dopamine or dobutamine > 5 mcg/kg/min, or any dose of epinephrine, norepinephrine, milrinone or vasopressin if used to treat hypotension. 2. Respiratory Failure: Acute mechanical ventilation via endotracheal tube or tracheostomy.
  • Age >= 2 wks 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
  • Diffuse skin disease that does not allow securement of a subcutaneous sensor
  • Therapeutic plan to remain intubated for >28 days
  • Ward of the state
  • Pregnancy

Gender

Both

Ages

17 Years and younger

Accepts Healthy Volunteers

No

Study Locations and Contact Information (49)

Study Location Distance Name Phone Email
YaleNew Haven Childrens Hospital - New Haven, Connecticut 18.1 miles None None None
Westchester Medical Center - Valhalla, New York 28.9 miles None None None
Westchester Medical Center - Valhalla, New York 28.9 miles Simon Li MD None None
North Shore LIJ Cohen Childrens Medical Center - New Hyde Park, New York 39.6 miles None None None
The Childrens Hospital at Montefiore - Bronx, New York 40.3 miles None None None
Morgan Stanley Childrens Hospital of New York - New York, New York 44.8 miles None None None
Childrens Hospital of Philadelphia - Philadelphia, Pennsylvania 134.5 miles Vijay Srinivasan MD None None
Childrens Hospital of Philadelphia - Philadelphia, Pennsylvania 134.5 miles None None None
Boston Childrens Hospital - Boston, Massachusetts 135.8 miles None None None
NemoursAI DuPont Hospital for Children - Wilmington, Delaware 155.5 miles None None None
NemoursAI DuPont Hospital for Children - Wilmington, Delaware 155.5 miles Shirley Viteri MD None None
Dartmouth Hitchcock Medical Center - Lebanon, New Hampshire 179.7 miles None None None
Dartmouth Hitchcock Medical Center - Lebanon, New Hampshire 179.7 miles Sholeen Nett MD None None
Penn State Hershey Medical Center - Hershey, Pennsylvania 188.9 miles None None None
Penn State Hershey Medical Center - Hershey, Pennsylvania 188.9 miles Neal J Thomas MD None None
Johns Hopkins Hospital - Baltimore, Maryland 219.6 miles None None None
Johns Hopkins Hospital - Baltimore, Maryland 219.6 miles None None None
University of Maryland Medical Center - Baltimore, Maryland 222.5 miles None None None
Women and Childrens Hospital of Buffalo - Buffalo, New York 312.2 miles None None None
Duke Childrens Hospital and Medical Center - Durham, North Carolina 474.1 miles None None None
Duke Childrens Hospital and Medical Center - Durham, North Carolina 474.1 miles Kyle Rehder MD None None
CS Mott Childrens Hospital - Ann Arbor, Michigan 545.4 miles Heidi Flori MD None None
CS Mott Childrens Hospital - Ann Arbor, Michigan 545.4 miles None None None
Cincinnati Childrens Hospital - Cincinnati, Ohio 611.0 miles None None None
Cincinnati Childrens Hospital - Cincinnati, Ohio 611.0 miles Ranjit S Chima MD None None
Medical University of South Carolina - Charleston, South Carolina 691.2 miles None None None
University of Louisville - Louisville, Kentucky 696.1 miles None None None
University of Chicago Comer Childrens Hospital - Chicago, Illinois 744.7 miles None None None
Ann Robert H Lurie Childrens Hospital pf Chicago - Chicago, Illinois 745.5 miles None None None
Ann Robert H Lurie Childrens Hospital pf Chicago - Chicago, Illinois 745.5 miles Lauren Marsillio MD None None
Childrens Healthcare of Atlanta - Atlanta, Georgia 795.6 miles None None None
St Louis Childrens Hospital - St. Louis, Missouri 919.8 miles None None None
St Louis Childrens Hospital - St. Louis, Missouri 919.8 miles None None None
Medical City Childrens Dallas - Dallas, Texas 1,417.3 miles None None None
Medical City Childrens Dallas - Dallas, Texas 1,417.3 miles G Kris Bysani MD None None
Childrens Medical Center Dallas - Dallas, Texas 1,422.5 miles None None None
Childrens Hospital Colorado - Aurora, Colorado 1,658.2 miles None None None
Childrens Hospital Colorado - Aurora, Colorado 1,658.2 miles None None None
Primary Childrens Hospital - Salt Lake City, Utah 2,000.4 miles None None None
Childrens Hospital of Orange County - Orange, California 2,477.9 miles Adam Schwarz MD None None
Childrens Hospital of Orange County - Orange, California 2,477.9 miles None None None
Childrens Hospital of Los Angelos - Los Angeles, California 2,489.4 miles Christopher Newth MD None None
Childrens Hospital of Los Angelos - Los Angeles, California 2,489.4 miles None None None
Miller Childrens Hospital Long Beach - Long Beach, California 2,493.3 miles None None None
Miller Childrens Hospital Long Beach - Long Beach, California 2,493.3 miles Christopher Babbitt MD None None
Mattel Childrens Hospital - Los Angelos, California 2,499.3 miles None None None
Mattel Childrens Hospital - Los Angelos, California 2,499.3 miles Myke Federman MD None None
Childrens Hospital Research Center of Oakland - Oakland, California 2,594.6 miles None None None
UCSF Benioff Childrens Hospital - San Francisco, California 2,606.4 miles None None None

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