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Completed

NCT Number: NCT03482154

Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population

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.

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Key information

Conditions

Stem Cell Transplant Complications Glucose Metabolism Disorders Hyperglycemia Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

Up to 30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hematopoietic stem cell transplant

Procedure

Allogeneic and autologous stem cell transplants covering both malignant and non-malignant diagnoses.

Primary outcomes

  1. Number of patients experiencing malglycemia in primary admission for pediatric HSCT patients

    Time frame: Transplant Day -14 to +100

    hypoglycemia (BG < 70 mg/dL), hyperglycemia (BG ≥ 126 mg/dL), or glycemic variability (σ ≥ 29 mg/dL)

  2. Number of patients with versus without malglycemia who experience infection

    Time frame: 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

Secondary outcomes

  1. Determine whether specific exposures are associated with increased occurrence of malglycemia

    Time frame: 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

  2. Survival rate of patients with versus without malglycemia

    Time frame: 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

  3. Occurrence of graft-versus-host disease (GVHD) in patients with versus without malglycemia

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 29, 2018
Registry last updated
Sep 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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