Hyperglycemia, Hypoglycemia, Stem Cell Transplant Complications
Conditions
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.
Interventions
PROCEDUREHematopoietic Stem Cell Transplant
Allogeneic and autologous stem cell transplants covering both malignant and non-malignant diagnoses.
Sponsors
University of Colorado, Denver
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 30 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed