Critical Care Outcomes of Patients With Hematologic Malignancy and Hematopoietic Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 415
- 试验地点
- 13
- 主要终点
- 1 year survival
研究概览
简要总结
Hematologic malignancy patients are admitted to ICU in increasing numbers. Successful ICU intervention has led to an increasing number of ICU survivors; however, there is a lack of information available about these patients' long term survival and quality of life. There is little Canadian data regarding ICU survival and regarding 1-year survival and functional outcomes in this group of patients. Over 500 patients are admitted annually to Canadian ICUs with an underlying hematologic malignancy or stem cell transplant, yet there is a paucity of up to date long-term outcome data. This information will facilitate a better understanding who would best benefit from critical care interventions and the impact of critical illness on their level of function at 1 year as well as survival.
详细描述
At the time of ICU admission, the investigators will collect clinical data from the medical chart on a daily basis including demographics, pre-existing disease(s), treatment and reason for ICU admission.
At the time of ICU discharge, the investigators will measure exercise tolerance and quality of life at 3 time intervals (Phase 2).
For Phase 2, patients will be seen at day 7 following ICU discharge, 6 months following ICU discharge and 12 months after ICU discharge during their routine oncology follow up visits. During these visits, they will undergo a functional assessment (6 minute walk test) and questionnaires to determine their quality of life following ICU (validated outcome measures).
All patients will complete outcome measures 1 to 5 below; Outcome measures 1 to 3 will be administered at 7 days and 1 to 5 at 6 months and 12 months after ICU discharge.
Validated Outcomes Measures:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects >16 years with Hematologic Malignancy (HM) or post Stem Cell Transplant (HCT) who require ICU admission.
- •HM includes: acute myeloid leukemia, acute lymphocytic leukemia, chronic myeloid leukemia, chronic lymphocytic leukemia, myeloma, lymphoma, myelofibrosis, and other myeloproliferative disorders or myelodysplastic syndromes.
- •HCT is defined as the transplantation of multipotent hematopoietic stem cells from bone marrow, peripheral blood, or umbilical cord blood.
排除标准
- •Subjects with significant preexisting neurological or psychiatric disease will be excluded from Phase 2 (1-year follow-up) but will be included in Phase 1.
结局指标
主要结局
1 year survival
时间窗: 1 year
1 year survival in enrolled patients
次要结局
- 6 month Clinical Frailty Scale (CFS)(6 months)
- 6 month Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT BMT)(6 months)
- 1 year functional outcome measured by the 6 minute walk test (6MWT)(1 year)
- 1 year Clinical Frailty Scale (CFS)(1 year)
- 1 year Short Form 36 Health Questionnaire (SF 36)(1 year)
- 6 month Functional Independent Measure questionnaire (FIM)(6 months)
- 1 year Functional Independent Measure questionnaire (FIM)(1 year)
- Intensive Care Unit survival(1 year)
- 6 month functional outcome measured by the 6 minute walk test (6MWT)(6 months)
- 6 month Short Form 36 Health Questionnaire (SF 36)(6 months)
- 1 year Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT BMT)(1 year)