Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202307787887272 Date of Approval: 17/07/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title African Critical Illness Outcomes Study
Official scientific title African Critical Illness Outcomes Study
Brief summary describing the background and objectives of the trial The number of patients with critical illness has not been accurately quantified, although data suggests that it exceeds 10% for hospital inpatients, and the in-hospital mortality of critically ill patients is between 18-82%. 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 (ACIOS). 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.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) ACIOS
Disease(s) or condition(s) being studied Critical illness - ICU/Critical Care patients
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/09/2023
Actual trial start date
Anticipated date of last follow up 02/12/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 10000
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
260 2023 University of Cape Town Human Ethics Committee
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Critically ill 7 days To investigate critical illness, its care and associated outcomes among all adult inpatients in hospitals across Africa. 10000 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All adult patients aged 18 years or over who have been admitted for inpatient care in any department or ward in participating hospitals. None 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/04/2023 University of Cape Town Human Research Ethics Commitee
Ethics Committee Address
Street address City Postal code Country
Old Main Building, Groote Schuur Hospital, Main Road, Observatory, Cape Town, 7925, South Africa Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To investigate critical illness, its care and associated outcomes among all adult in-patients in hospitals across Africa. 7 day period at each hospital
Secondary Outcome 1. To establish the proportion of adult (18 years or older) inpatients in African hospitals that are critically ill. 2. To establish the mortality rate of the critically ill patients and those who are not critically ill. 3. To estimate the proportion of critically ill patients who receive essential emergency and critical care. 4. To investigate the association between the provision of essential emergency and critical care to critically ill patients and mortality. 5. To determine the availability of resources for essential emergency and critical in African hospitals. 7 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Groote Schuur Hospital Main Road, Observatory Cape Town 7925 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
NIHR D23, Groote Schuur Hospital Cape Town 7925 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor NIHR D23, Groote Schuur Hospital Cape Town 7925 South Africa Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Dr Tim Baker Department of Emergency Medicine Muhimbili University of Health and Allied Sciences Dar es Salaam Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dr Tim Baker tim.baker@ki.se +255683236765 Department of Emergency Medicine Muhimbili University of Health and Allied Sciences
City Postal code Country Position/Affiliation
Dar es Salaam Tanzania Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Bruce Biccard bruce.biccard@uct.ac.za 0027214045015 Department of Anaesthesia and Perioperative Medicine, University of Cape Town
City Postal code Country Position/Affiliation
Cape Town South Africa Co chief Principal Investigator and Scientific enquiries
Role Name Email Phone Street address
Public Enquiries Margot Flint margot.flint@uct.ac.za +274045144 Department of Anaesthesia and Perioperative Medicine, University of Cape Town
City Postal code Country Position/Affiliation
Cape Town South Africa Public enquiries
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual patient data (IPD) Sharing Statement specific to this project includes the de-identified data to be made available for research purposes by contacting the first author. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis Qualified researchers
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information