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ACIOS: The African Critical Illness Outcomes Study

Sponsor
University of Cape Town (Other)
Overall Status
Recruiting
CT.gov ID
NCT06051526
Collaborator
Muhimbili University of Health and Allied Sciences (Other)
10,000
Enrollment
1
Location
3.2
Anticipated Duration (Months)
3137.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    10000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The African Critical Illness Outcomes Study
    Actual Study Start Date :
    Sep 1, 2023
    Anticipated Primary Completion Date :
    Nov 30, 2023
    Anticipated Study Completion Date :
    Dec 7, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Critically ill in-patients

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

    Outcome Measures

    Primary Outcome Measures

    1. Presence of critical illness [7 days]

      The number of participants with critical illness.

    2. In-hospital mortality (censored at 7-days) [7 days]

      To investigate the association between the provision of essential emergency and critical care to critically ill patients and mortality.

    Secondary Outcome Measures

    1. Provision of essential emergency and critical care [7 days]

      To estimate the proportion of critically ill patients who receive essential emergency and critical care.

    2. Length of hospital stay [7 days]

      Length of hospital stay for critically ill patients

    3. Number of essential emergency and critical care resources available for care [7 days]

      The number of resources available for the provision of essential emergency and critical care

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Merowe Daman Hospital Khartoum Sudan

    Sponsors and Collaborators

    • University of Cape Town
    • Muhimbili University of Health and Allied Sciences

    Investigators

    • Principal Investigator: Tim Baker, MBChB; PhD, Muhimbili University of Health and Allied Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bruce Biccard, Co-chief Investigator, University of Cape Town
    ClinicalTrials.gov Identifier:
    NCT06051526
    Other Study ID Numbers:
    • ACIOS
    First Posted:
    Sep 25, 2023
    Last Update Posted:
    Sep 25, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Critical Illness

    Study Results

    No Results Posted as of Sep 25, 2023