The African Critical Illness Outcomes Study

NCT ID: NCT06051526

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20159 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-01-03

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.

Conditions

Critical Illness; Mortality

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Critically ill in-patients

All adult inpatients in hospitals across Africa that are critically ill.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Muhimbili University of Health and Allied Sciences

OTHER

Sponsor Role: collaborator

University of Cape Town

OTHER

Sponsor Role: lead

Responsible Party

Bruce Biccard

Co-chief Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tim Baker, MBChB; PhD

Role: PRINCIPAL_INVESTIGATOR

Muhimbili University of Health and Allied Sciences

Locations

Merowe Daman Hospital

Khartoum, , Sudan

Countries

Sudan

References

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Provided Documents

Document Type: Study Protocol

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Document Type: Statistical Analysis Plan: Main study statistical analysis plan

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Document Type: Statistical Analysis Plan: Pain substudy statistical analysis plan

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Other Identifiers

ACIOS

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Identifier Source: org_study_id