Clinical Characteristics and Outcomes of Patients Admitted to Kenyan Critical Care Units During the COVID-19 Pandemic: a Multicenter Registry-based Observational Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 4,000
- 试验地点
- 6
- 主要终点
- Length of ICU stay
研究概览
简要总结
The Kenyan Critical Care Registry was started in December 2020 and currently involves 10 critical care units in 6 Hospitals. As an initial registry output, we aim to describe patient epidemiological characteristics, initial management and outcomes of critically ill patients in Kenya. This project will provide a much-needed source of clinico-demographic and outcomes data for participating Kenyan critical care units. It will also help to identify processes and outcomes which can be targeted by quality improvement projects, the impact of which can then be evaluated later using the registry.
详细描述
Background:
The burden of critically ill patients is growing in low and middle income countries (LMICs), but the resources available to assist these patients are limited.1 Critical care is an established and rapidly evolving service in Kenya.2 Yet, patient epidemiological characteristics, patterns of ICU management and patient outcomes in Kenyan ICUs remain scarcely investigated.3,6,7
The ICU registry:
The Kenyan Critical Care Registry was started in December 2020 after receiving ethical approval in November 2020, and currently involves 10 units in 6 Hospitals. The registry was launched in collaboration with the Network for Intensive Care Systems and Training (NICST) and the Mahidol Oxford Research Unit (MORU). As in other countries, the Kenyan Critical Care registry aims to play an increasingly pivotal role in evaluating treatment outcomes, benchmarking services and providing opportunities for service forecasting. Dedicated data collectors in each registry site perform real-time data collection. All registry data is housed and stored securely on a national server located on Kenyan soil. Once entered electronically on password-protected computers at participating facilities, it is automatically encrypted before it leaves the institution for the visualization loop within a ring-fenced server at NICST, where it is unencrypted and aggregated for automated visualization. NICST follows healthcare standard GDP and HIPAA standards. The processed data is then re-encrypted before it is transferred back to the national server, where it is automatically unencrypted and available for review by authorized personnel, through a secure two step log in - a process that is navigated with the help of Kenyan IT teams. An audit trail is created any time the registry is accessed, to see who has logged into it, when, and what data was retrieved or modified.
Study aims:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to an intensive care unit or high dependency unit
- •Included in the Kenya Critical Care registry platform
排除标准
- 未提供
结局指标
主要结局
Length of ICU stay
时间窗: 1 month
duration of stay in the ICU or HDU in days
ICU mortality
时间窗: 1 month
death during ICU or HDU stay
Demographic characteristics
时间窗: ICU admission
The following demographic characteristics are collected: age, sex
APACHE 2 score
时间窗: ICU admission
Acute Physiology and Chronic Evaluation 2 score
次要结局
- Tracheostomy rate(1 month)
- Patients receiving mechanical ventilation(1 month)
- Use of antibiotics on ICU admission(ICU admission - first 24h)
- Reason for admission(ICU admission - first 24h)
- Use of sedatives(ICU admission - first 24h)
- Use of vasopressors(ICU admission - first 24h)