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临床试验/NCT03482154
NCT03482154已完成不适用

Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 344 人开始时间: 2016年9月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
344
试验地点
1
主要终点
Number of patients with versus without malglycemia who experience infection

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
— 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Number of patients with versus without malglycemia who experience infection

时间窗: 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

时间窗: Transplant Day -14 to +100

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

次要结局

  • Determine whether specific exposures are associated with increased occurrence of malglycemia(Transplant Day -14 to +100)
  • Survival rate of patients with versus without malglycemia(Transplant Day 0 through date of relapse or death)
  • Occurrence of graft-versus-host disease (GVHD) in patients with versus without malglycemia(Transplant Day 0 through date of relapse or death)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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