Coagulation and Fibrinolysis in Pediatric Insulin Titration Trial (CAF-PINT)
CAF-PINT
2 other identifiers
observational
304
1 country
25
Brief Summary
Project Summary We propose an ancillary study to The Heart and Lung Failure Pediatric Insulin Titration trial (HALF PINT), which is investigating the impact of normalizing blood glucose using insulin infusions on clinical outcomes among children with hyperglycemia and heart and lung failure. In this ancillary study, we will measure plasma levels of inflammatory, coagulation, and fibrinolysis proteins and genotype DNA for polymorphisms among patients enrolled in the HALF PINT trial. The results from this ancillary study will help us to understand potential mechanisms through which normalizing blood glucose provides benefit, which may lead to development of new therapeutic strategies in critically ill children
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2012
Longer than P75 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 26, 2013
CompletedFirst Posted
Study publicly available on registry
July 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedJuly 31, 2020
July 1, 2020
3.9 years
June 26, 2013
July 29, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Biomarkers of Thrombosis and Inflammation (Interleukin 6 (IL6) and Interleukin 8 (IL8) , Plasminogen Activator Inhibitor -1 (PAI-1))
The researchers will measure IL-6, IL-8 and PAI-1 on patient plasma using a Luminex based multiplex array. All measurements are in pg/mL. The Slope of change in biomarkers from the time of start of insulin infusion to 2 and 4 days after start of insulin infusion will be used as the outcome measure.
4 days
Secondary Outcomes (1)
Number of participants with Development of Acute Lung Injury (ALI)
28 days
Study Arms (1)
HEART AND LUNG FAILURE
Patients with Heart failure or Respiratory Failure with Hyperglycemia
Eligibility Criteria
Patients Enrolled in the Half Pint Trial to study the efficacy of Tight Glycemic control using Insulin on reducing organ failure and mortality among children with Heart and Lung Failure with Hyperglycemia
You may qualify if:
- All Patients enrolled in the HALF PINT trial
You may not qualify if:
- Bleeding Diathesis as manifest by a Most Recent recorded International Normalized ratio (INR) \>3
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
Mattel Children's Hospital (UCLA)
Los Angeles, California, 90095, United States
Children's Hospital and Research Center of Oakland
Oakland, California, 94609, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Children's Hospital Colorado - Denver
Aurora, Colorado, 84005, United States
Yale - New Haven Children's Hospital
New Haven, Connecticut, 06520, United States
Nemours/Alfred I. DuPont Hospital for Children
Wilmington, Delaware, 19803, United States
Children's Healthcare of Atlanta (Emory)
Atlanta, Georgia, 30322, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
University of Chicago Medicine Comer Children's Hospital
Chicago, Illinois, 60637, United States
Indiana University Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
University of Louisville Children's Hospital
Louisville, Kentucky, 40202, United States
Children's Hospital of Boston
Boston, Massachusetts, 02115, United States
C.S. Mott Children's Hospital - Michigan
Ann Arbor, Michigan, 48109, United States
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Dartmouth Hitchcock Medical Center
Manchester, New Hampshire, 03104, United States
Women and Children's Hospital of Buffalo
Buffalo, New York, 14222, United States
Cohen Children's Medical Center of NY/ North Shore LIJ
New Hyde Park, New York, 11743, United States
Maria Fareri Children's Hospital at Westchester Medical Center
Valhalla, New York, 10595, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
PennState Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Medical City Children's Dallas
Dallas, Texas, 75230, United States
Children's Medical Center Dallas
Dallas, Texas, 75390, United States
Primary Children's Medical Center
Salt Lake City, Utah, 84102, United States
Related Publications (1)
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.
PMID: 36656551DERIVED
Biospecimen
Blood Samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anil Sapru, MD,MAS
University of California, Los Angeles
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2013
First Posted
July 8, 2013
Study Start
October 1, 2012
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
July 31, 2020
Record last verified: 2020-07