The African Critical Illness Outcomes Study

Critical Illness Clinical Trial

— ACIOS  

Official title:

The African Critical Illness Outcomes Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06051526
• Other study ID #: ACIOS
• Status: Completed
• Start date: September 1, 2023
• Est. completion date: January 3, 2024

Study information

• Verified date: April 2024
• Source: University of Cape Town
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20159
• Est. completion date: January 3, 2024
• Est. primary completion date: January 3, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Mortality

Locations

Country	Name	City	State
Sudan	Merowe Daman Hospital	Khartoum

Sponsors (2)

Lead Sponsor	Collaborator
University of Cape Town	Muhimbili University of Health and Allied Sciences

Country where clinical trial is conducted

Sudan, 

References & Publications (33)

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African COVID-19 Critical Care Outcomes Study (ACCCOS) Investigators. Patient care and clinical outcomes for patients with COVID-19 infection admitted to African high-care or intensive care units (ACCCOS): a multicentre, prospective, observational cohort — View Citation

ASOS-2 Investigators. Enhanced postoperative surveillance versus standard of care to reduce mortality among adult surgical patients in Africa (ASOS-2): a cluster-randomised controlled trial. Lancet Glob Health. 2021 Oct;9(10):e1391-e1401. doi: 10.1016/S22 — View Citation

Baker T, Blixt J, Lugazia E, Schell CO, Mulungu M, Milton A, Castegren M, Eriksen J, Konrad D. Single Deranged Physiologic Parameters Are Associated With Mortality in a Low-Income Country. Crit Care Med. 2015 Oct;43(10):2171-9. doi: 10.1097/CCM.0000000000 — View Citation

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Baker T, Lugazia E, Eriksen J, Mwafongo V, Irestedt L, Konrad D. Emergency and critical care services in Tanzania: a survey of ten hospitals. BMC Health Serv Res. 2013 Apr 16;13:140. doi: 10.1186/1472-6963-13-140. — View Citation

Baker T, Schell CO, Lugazia E, Blixt J, Mulungu M, Castegren M, Eriksen J, Konrad D. Vital Signs Directed Therapy: Improving Care in an Intensive Care Unit in a Low-Income Country. PLoS One. 2015 Dec 22;10(12):e0144801. doi: 10.1371/journal.pone.0144801. — View Citation

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Buowari DY, Owoo C, Gupta L, Schell CO, Baker T; EECC Network Group. Essential Emergency and Critical Care: A Priority for Health Systems Globally. Crit Care Clin. 2022 Oct;38(4):639-656. doi: 10.1016/j.ccc.2022.06.008. — View Citation

Crawford AM, Shiferaw AA, Ntambwe P, Milan AO, Khalid K, Rubio R, Nizeyimana F, Ariza F, Mohammed AD, Baker T, Banguti PR, Madzimbamuto F. Global critical care: a call to action. Crit Care. 2023 Jan 20;27(1):28. doi: 10.1186/s13054-022-04296-3. — View Citation

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International Surgical Outcomes Study group. Global patient outcomes after elective surgery: prospective cohort study in 27 low-, middle- and high-income countries. Br J Anaesth. 2016 Oct 31;117(5):601-609. doi: 10.1093/bja/aew316. Erratum In: Br J Anaest — View Citation

Jenson A, Hansoti B, Rothman R, de Ramirez SS, Lobner K, Wallis L. Reliability and validity of emergency department triage tools in low- and middle-income countries: a systematic review. Eur J Emerg Med. 2018 Jun;25(3):154-160. doi: 10.1097/MEJ.0000000000 — View Citation

Kause J, Smith G, Prytherch D, Parr M, Flabouris A, Hillman K; Intensive Care Society (UK); Australian and New Zealand Intensive Care Society Clinical Trials Group. A comparison of antecedents to cardiac arrests, deaths and emergency intensive care admiss — View Citation

Kayambankadzanja RK, Likaka A, Mndolo SK, Chatsika GM, Umar E, Baker T. Emergency and critical care services in Malawi: Findings from a nationwide survey of health facilities. Malawi Med J. 2020 Mar;32(1):19-23. doi: 10.4314/mmj.v32i1.5. — View Citation

Kayambankadzanja RK, Schell CO, Gerdin Warnberg M, Tamras T, Mollazadegan H, Holmberg M, Alvesson HM, Baker T. Towards definitions of critical illness and critical care using concept analysis. BMJ Open. 2022 Sep 5;12(9):e060972. doi: 10.1136/bmjopen-2022- — View Citation

Kayambankadzanja RK, Schell CO, Mbingwani I, Mndolo SK, Castegren M, Baker T. Unmet need of essential treatments for critical illness in Malawi. PLoS One. 2021 Sep 10;16(9):e0256361. doi: 10.1371/journal.pone.0256361. eCollection 2021. — View Citation

Kellett J, Deane B. The Simple Clinical Score predicts mortality for 30 days after admission to an acute medical unit. QJM. 2006 Nov;99(11):771-81. doi: 10.1093/qjmed/hcl112. Epub 2006 Oct 17. — View Citation

Kruisselbrink R, Kwizera A, Crowther M, Fox-Robichaud A, O'Shea T, Nakibuuka J, Ssinabulya I, Nalyazi J, Bonner A, Devji T, Wong J, Cook D. Modified Early Warning Score (MEWS) Identifies Critical Illness among Ward Patients in a Resource Restricted Settin — View Citation

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Meara JG, Leather AJ, Hagander L, Alkire BC, Alonso N, Ameh EA, Bickler SW, Conteh L, Dare AJ, Davies J, Merisier ED, El-Halabi S, Farmer PE, Gawande A, Gillies R, Greenberg SL, Grimes CE, Gruen RL, Ismail EA, Kamara TB, Lavy C, Lundeg G, Mkandawire NC, R — View Citation

Mekontso Dessap A, Richard JM, Baker T, Godard A, Carteaux G. Technical Innovation in Critical Care in a World of Constraints: Lessons from the COVID-19 Pandemic. Am J Respir Crit Care Med. 2023 May 1;207(9):1126-1133. doi: 10.1164/rccm.202211-2174CP. — View Citation

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Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaes — View Citation

Phua J, Faruq MO, Kulkarni AP, Redjeki IS, Detleuxay K, Mendsaikhan N, Sann KK, Shrestha BR, Hashmi M, Palo JEM, Haniffa R, Wang C, Hashemian SMR, Konkayev A, Mat Nor MB, Patjanasoontorn B, Nafees KMK, Ling L, Nishimura M, Al Bahrani MJ, Arabi YM, Lim CM, — View Citation

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Schell CO, Gerdin Warnberg M, Hvarfner A, Hoog A, Baker U, Castegren M, Baker T. The global need for essential emergency and critical care. Crit Care. 2018 Oct 29;22(1):284. doi: 10.1186/s13054-018-2219-2. — View Citation

Smith AF, Wood J. Can some in-hospital cardio-respiratory arrests be prevented? A prospective survey. Resuscitation. 1998 Jun;37(3):133-7. doi: 10.1016/s0300-9572(98)00056-2. — View Citation

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Towey RM, Ojara S. Practice of intensive care in rural Africa: an assessment of data from Northern Uganda. Afr Health Sci. 2008 Mar;8(1):61-4. No abstract available. — View Citation

* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of critical illness	The number of participants with critical illness.	7 days
Primary	In-hospital mortality (censored at 7-days)	The number of participants with in-hospital mortality (censored at 7-days)	7 days
Secondary	Provision of essential emergency and critical care	To number of critically ill patients who receive essential emergency and critical care.	7 days
Secondary	Length of hospital stay	The length of hospital stay for critically ill patients	7 days
Secondary	Number of essential emergency and critical care resources available for care	The number of essential emergency and critical care resources available	7 days