Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population

Hyperglycemia Clinical Trial

Official title:

Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03482154
• Other study ID #: 16-1496.cc
• Status: Completed
• Start date: September 6, 2016
• Est. completion date: June 30, 2019

Study information

• Verified date: September 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 344
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperglycemia
• Hypoglycemia
• Stem Cell Transplant Complications

Intervention

Procedure:
• Hematopoietic Stem Cell Transplant
Allogeneic and autologous stem cell transplants covering both malignant and non-malignant diagnoses.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients experiencing malglycemia in primary admission for pediatric HSCT patients	hypoglycemia (BG < 70 mg/dL), hyperglycemia (BG = 126 mg/dL), or glycemic variability (s = 29 mg/dL)	Transplant Day -14 to +100
Primary	Number of patients with versus without malglycemia who experience infection	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	Transplant Day 0 to +100
Secondary	Determine whether specific exposures are associated with increased occurrence of malglycemia	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	Transplant Day -14 to +100
Secondary	Survival rate of patients with versus without malglycemia	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	Transplant Day 0 through date of relapse or death
Secondary	Occurrence of graft-versus-host disease (GVHD) in patients with versus without malglycemia	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	Transplant Day 0 through date of relapse or death