A Multicenter Study to Improve Management and Outcomes In Immunocompromised Patients with Acute Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Mortality risk factors in the short and medium term
研究概览
简要总结
We designed this multicenter retrospective study to appraise outcomes in immunocompromised patients with ARF. Our research group includes about seventy intensive care units in sixteen countries. Five more countries have decided to join our group starting with this study (see appendix 1). Participating centers are clinical experts in the field of critical care and are dedicated to the care of critically ill immunocompromised patients.
Inclusion criteria are:
a) adult patients
b) admitted to the ICU between January 1, 2017 and December 31, 2022
c) with acute respiratory failure (oxygen dependence >6l/min to achieve a SpO2>92 and/or respiratory rate >30/min and/or laboured breathing and/or the need for non-invasive or invasive mechanical ventilation or high-flow nasal canula;
d) with a known immunodepression (hematological malignancy (including autologous and allogeneic stem cell transplant), solid tumor requiring treatements over the last five years, solid organ transplant, immunosuppressive drugs for auto-immune or auto-inflammatory diseases, and primary immunodeficiency). Patients with isolated HIV infection are not eligible for this study.
The primary objective is mortality 90 days after ICU admission, with a specific attention to outcomes in patients with undetermined ARF etiology. Secondary objectives are the determinants of escalation from standard oxygen therapy to the ceiling of therapy, including intubation, rescue strategies to optimize oxygenation in ARDS, and ECMO. Variables will also be collected to better assess the center effect. This will be the largest cohort of immunocompromised patients with ARF. We ambition to provide updated benchmarks on the management and outcomes of these patients and identify areas for improvement in care and generate hypotheses to improve practices.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1 adult patients 2 admitted to the ICU between 1 Jan 2017 to 31 Dec 2022
- •with acute respiratory failure oxygen dependance more than 6 liter per min to achieve SPO2 more than 92 percentage and or respiratory rate more than 30 per minute and or labored breathing and or the need for non invasive or invasive mechanical ventilation or high flow nasal cannula 4 with a known immunodepression hematological malignancy including autologous and allogeneic stem cell transplant, solid tumor requiring treatments over the last five years, solid organ transplant, immunosuppressive drugs for auto-immune or auto inflammatory disease and primary immunodeficeincy.
排除标准
- •Patients with isolated HIV infection are not eligible for this study
- •Patients already included in the cohort
- •Patient refuse for consent and data collection
- •Patients deprived of liberty under guardianship or curatorship.
结局指标
主要结局
Mortality risk factors in the short and medium term
时间窗: survival at 3 months of immunocompromised patients after ICU admission
次要结局
- to identify the prognostic factors for day-90 mortality.(90 days from the date of ICU admission)
- A comparison between different intensive care units in terms of mortality and management strategies.(comparison of factor affecting the 90 days mortality)
研究者
Sheila N Myatra
Tata Memorial Hospital