The African Critical Illness Outcomes Study

Completed

• Conditions: Mortality; Critical Illness

• Registration Number: NCT06051526
• Lead Sponsor: University of Cape Town

Brief Summary

In Africa, the prevalence of critical illness is likely to be higher due to a greater burden of disease, and the associated mortality higher due to limited resources. This is a prospective, observational study to rapidly establish the prevalence of critical illness in in-hospital adult patients in Africa, and the resources available to provide essential critical care (care that should be available to every patient in the world) and factors associated with mortality. Rapid dissemination of these findings may help mitigate mortality from critical illness in Africa. These points provide the rationale for the African Critical Illness Outcomes Study.

Detailed Description

STUDY OBJECTIVES

The objectives of this study are to determine:

1. The proportion of hospital patients who are critically ill,

2. The mortality associated with critical illness,

3. The proportion of critically ill patients who receive essential emergency and critical care,

4. The relationship between essential emergency and critical care provision, and mortality, and

5. The availability of resources necessary to provide essential emergency and critical care.

STUDY DESIGN

An African multi-centre prospective observational cohort study of adult (≥18 years) in-hospital patients. Patient follow up will be for a maximum of 7 days in-hospital.

The primary outcome is in-hospital mortality in adult hospital patients with and without critical illness in Africa.

The intention is to provide a representative sample of the mortality, the risk factors associated with mortality in adult patients with critical illness, and the resources available and interventions provided to treat critical illness in Africa. This study will run between September and November 2023.

PREPARATORY WORK

This study will be run by the African Perioperative Research Group (APORG), with a network of over 600 hospitals in more than 40 African countries which has successfully conducted the African Surgical Outcomes Study (ASOS), the ASOS-2 Trial, the African COVID-19 Critical Care Outcomes Study (ACCCOS) and the African Pediatric Surgical Outcomes Study (ASOS-PEDS).

IMPORTANCE OF THIS STUDY

To decrease the mortality associated with critical illness in Africa, it is important to rapidly establish the potential risk factors for mortality, and resources available to manage these patients. The APORG network has the capacity to provide these data timeously.

Study Timeline

• Study Start: 2023-09-01
• Study First Submitted: 2023-09-01
• Study First Submitted QC: 2023-09-20
• Study First Posted: 2023-09-25
• Primary Completion: 2024-01-03
• Study Completion: 2024-01-03
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20159

Inclusion Criteria

• All adult patients aged 18 years or over who have been admitted for inpatient care in any department or ward in participating hospitals.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of critical illness	7 days	The number of participants with critical illness.
In-hospital mortality (censored at 7-days)	7 days	The number of participants with in-hospital mortality (censored at 7-days)

Secondary Outcome Measures

Name	Time	Method
Provision of essential emergency and critical care	7 days	To number of critically ill patients who receive essential emergency and critical care.
Length of hospital stay	7 days	The length of hospital stay for critically ill patients
Number of essential emergency and critical care resources available for care	7 days	The number of essential emergency and critical care resources available

Trial Locations

Locations (1)

Merowe Daman Hospital; 🇸🇩 Khartoum, Sudan