Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population

Completed

• Conditions: Stem Cell Transplant Complications; Hypoglycemia; Hyperglycemia
• Interventions: Procedure: Hematopoietic Stem Cell Transplant

• Registration Number: NCT03482154
• Lead Sponsor: University of Colorado, Denver

Brief Summary

This is a retrospective chart review of patients who underwent a hematopoietic stem cell transplant (HSCT) between 1994 and 2016 to evaluate incidence of malglycemia and the relationship to specific outcomes.

Detailed Description

This is a retrospective chart review of patients who underwent a hematopoietic stem cell transplant between 2007 and 2016 to evaluate incidence and risk factors of malglycemia. The review will also aim to characterize relationships between specific outcomes and malglycemia in pediatric HSCT patients.

Study Timeline

• Study Start: 2016-09-06
• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-03-22
• Study First Posted: 2018-03-29
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-26
• Last Update Posted: 2019-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 344

Inclusion Criteria

• Age 0 to 30 years old at time of transplant
• Bone Marrow Transplant (BMT) recipient at Children's Hospital Colorado (CHCO) between 1/1/2007 and 7/31/2016

Exclusion Criteria

• Preexisting diabetes mellitus or known hyperglycemia
• Inadequate blood glucose data for analysis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Without Malglycemia	Hematopoietic Stem Cell Transplant	-
With Malglycemia	Hematopoietic Stem Cell Transplant	-

Primary Outcome Measures

Name	Time	Method
Number of patients with versus without malglycemia who experience infection	Transplant Day 0 to +100	It is hypothesized that patients who experience malglycemia will have an increased rate of post-transplant infections. This outcome will be assessed for differences in incidence based on malglycemia occurence
Number of patients experiencing malglycemia in primary admission for pediatric HSCT patients	Transplant Day -14 to +100	hypoglycemia (BG \< 70 mg/dL), hyperglycemia (BG ≥ 126 mg/dL), or glycemic variability (σ ≥ 29 mg/dL)

Secondary Outcome Measures

Name	Time	Method
Determine whether specific exposures are associated with increased occurrence of malglycemia	Transplant Day -14 to +100	The occurrence of the outcome, malglycemia, with be assessed for differences in incidence that may occur as a result of age, medication exposures (use of glucocorticoids, asparaginase, total parenteral nutrition (TPN), or calcineurin inhibitors), underlying diagnosis, and transplant type
Survival rate of patients with versus without malglycemia	Transplant Day 0 through date of relapse or death	It is hypothesized that patients who experience malglycemia will have an increased rate of post-transplant mortality. This outcome will be assessed for differences in incidence based on malglycemia occurrence
Occurrence of graft-versus-host disease (GVHD) in patients with versus without malglycemia	Transplant Day 0 through date of relapse or death	It is hypothesized that patients who experience malglycemia will have an increased rate of GVHD. This outcome will be assessed for differences in incidence based on malglycemia occurrence

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States