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CompletedNCT06051526ACIOSUpdated Apr 10, 2024

The African Critical Illness Outcomes Study

An observational study in Critical Illness and Mortality, sponsored by University of Cape Town. Completed at 1 site in Sudan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-10.

Sponsored by University of Cape Town · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20,159
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Critical Illness
  • Mortality

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03

In context

Critical Illness

1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.

This study's enrollment of 20,159 is above the median of 140 across 814 observational studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

University of Cape Town is the lead sponsor of 116 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • None
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20,159 participants (actual)
Patient registry
No

Groups and cohorts

  • Critically ill in-patients

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

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What researchers measure

Primary outcomes

  1. Presence of critical illness

    The number of participants with critical illness.

    Time frame: 7 days

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

    The number of participants with in-hospital mortality (censored at 7-days)

    Time frame: 7 days

Secondary outcomes

  1. Provision of essential emergency and critical care

    To number of critically ill patients who receive essential emergency and critical care.

    Time frame: 7 days

  2. Length of hospital stay

    The length of hospital stay for critically ill patients

    Time frame: 7 days

  3. Number of essential emergency and critical care resources available for care

    The number of essential emergency and critical care resources available

    Time frame: 7 days

07

Study locations

1 site
  • Merowe Daman Hospital
    Khartoum, Sudan
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References and documents

Publications

  • 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-2022-060972. PubMed 36606666 ↗
  • 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.0000000000000445. PubMed 28263204 ↗
  • 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 Setting in Kampala, Uganda: A Prospective Observational Study. PLoS One. 2016 Mar 17;11(3):e0151408. doi: 10.1371/journal.pone.0151408. eCollection 2016. PubMed 26986466 ↗
  • 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, Fang WF; Asian Analysis of Bed Capacity in Critical Care (ABC) Study Investigators, and the Asian Critical Care Clinical Trials Group. Critical Care Bed Capacity in Asian Countries and Regions. Crit Care Med. 2020 May;48(5):654-662. doi: 10.1097/CCM.0000000000004222. PubMed 31923030 ↗
  • Maharaj R, Raffaele I, Wendon J. Rapid response systems: a systematic review and meta-analysis. Crit Care. 2015 Jun 12;19(1):254. doi: 10.1186/s13054-015-0973-y. PubMed 26070457 ↗
  • 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. PubMed 32733655 ↗
  • 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. PubMed 23590288 ↗
  • 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. PubMed 34506504 ↗
  • 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. PubMed 30373648 ↗
  • 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. PubMed 36670506 ↗
  • 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. PubMed 36716353 ↗
  • 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. PubMed 36162903 ↗
  • Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C, Machado FR, Reinhart KK, Rowan K, Seymour CW, Watson RS, West TE, Marinho F, Hay SI, Lozano R, Lopez AD, Angus DC, Murray CJL, Naghavi M. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020 Jan 18;395(10219):200-211. doi: 10.1016/S0140-6736(19)32989-7. PubMed 31954465 ↗
  • Haagsma JA, Graetz N, Bolliger I, Naghavi M, Higashi H, Mullany EC, Abera SF, Abraham JP, Adofo K, Alsharif U, Ameh EA, Ammar W, Antonio CA, Barrero LH, Bekele T, Bose D, Brazinova A, Catala-Lopez F, Dandona L, Dandona R, Dargan PI, De Leo D, Degenhardt L, Derrett S, Dharmaratne SD, Driscoll TR, Duan L, Petrovich Ermakov S, Farzadfar F, Feigin VL, Franklin RC, Gabbe B, Gosselin RA, Hafezi-Nejad N, Hamadeh RR, Hijar M, Hu G, Jayaraman SP, Jiang G, Khader YS, Khan EA, Krishnaswami S, Kulkarni C, Lecky FE, Leung R, Lunevicius R, Lyons RA, Majdan M, Mason-Jones AJ, Matzopoulos R, Meaney PA, Mekonnen W, Miller TR, Mock CN, Norman RE, Orozco R, Polinder S, Pourmalek F, Rahimi-Movaghar V, Refaat A, Rojas-Rueda D, Roy N, Schwebel DC, Shaheen A, Shahraz S, Skirbekk V, Soreide K, Soshnikov S, Stein DJ, Sykes BL, Tabb KM, Temesgen AM, Tenkorang EY, Theadom AM, Tran BX, Vasankari TJ, Vavilala MS, Vlassov VV, Woldeyohannes SM, Yip P, Yonemoto N, Younis MZ, Yu C, Murray CJ, Vos T. The global burden of injury: incidence, mortality, disability-adjusted life years and time trends from the Global Burden of Disease study 2013. Inj Prev. 2016 Feb;22(1):3-18. doi: 10.1136/injuryprev-2015-041616. Epub 2015 Dec 3. PubMed 26635210 ↗
  • 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, Raykar NP, Riesel JN, Rodas E, Rose J, Roy N, Shrime MG, Sullivan R, Verguet S, Watters D, Weiser TG, Wilson IH, Yamey G, Yip W. Global Surgery 2030: evidence and solutions for achieving health, welfare, and economic development. Lancet. 2015 Aug 8;386(9993):569-624. doi: 10.1016/S0140-6736(15)60160-X. Epub 2015 Apr 26. No abstract available. PubMed 25924834 ↗
  • Murthy S, Wunsch H. Clinical review: International comparisons in critical care - lessons learned. Crit Care. 2012 Dec 12;16(2):218. doi: 10.1186/cc11140. PubMed 22546146 ↗
  • Adhikari NK, Fowler RA, Bhagwanjee S, Rubenfeld GD. Critical care and the global burden of critical illness in adults. Lancet. 2010 Oct 16;376(9749):1339-46. doi: 10.1016/S0140-6736(10)60446-1. Epub 2010 Oct 11. PubMed 20934212 ↗
  • 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 study. Lancet. 2021 May 22;397(10288):1885-1894. doi: 10.1016/S0140-6736(21)00441-4. Erratum In: Lancet. 2021 Jun 26;397(10293):2466. doi: 10.1016/S0140-6736(21)01292-7. PubMed 34022988 ↗
  • Ilori IU, Kalu QN. Intensive care admissions and outcome at the University of Calabar Teaching Hospital, Nigeria. J Crit Care. 2012 Feb;27(1):105.e1-4. doi: 10.1016/j.jcrc.2011.11.011. PubMed 22304993 ↗
  • 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. PubMed 19357737 ↗
  • Gombar S, Ahuja V, Jafra A. A retrospective analysis of obstetric patient's outcome in intensive care unit of a tertiary care center. J Anaesthesiol Clin Pharmacol. 2014 Oct;30(4):502-7. doi: 10.4103/0970-9185.142843. PubMed 25425775 ↗
  • Subbe CP, Kruger M, Rutherford P, Gemmel L. Validation of a modified Early Warning Score in medical admissions. QJM. 2001 Oct;94(10):521-6. doi: 10.1093/qjmed/94.10.521. PubMed 11588210 ↗
  • 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 admissions in Australia and New Zealand, and the United Kingdom--the ACADEMIA study. Resuscitation. 2004 Sep;62(3):275-82. doi: 10.1016/j.resuscitation.2004.05.016. PubMed 15325446 ↗
  • 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. PubMed 9715771 ↗
  • 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. PubMed 17046859 ↗
  • 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.0000000000001194. PubMed 26154933 ↗
  • Baker T, Gerdin M. The clinical usefulness of prognostic prediction models in critical illness. Eur J Intern Med. 2017 Nov;45:37-40. doi: 10.1016/j.ejim.2017.09.012. Epub 2017 Sep 19. PubMed 28935477 ↗
  • 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 Anaesth. 2017 Sep 1;119(3):553. doi: 10.1093/bja/aew472. PubMed 27799174 ↗
  • 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 Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9. PubMed 22998715 ↗
  • 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. eCollection 2015. PubMed 26693728 ↗
  • Bell MB, Konrad D, Granath F, Ekbom A, Martling CR. Prevalence and sensitivity of MET-criteria in a Scandinavian University Hospital. Resuscitation. 2006 Jul;70(1):66-73. doi: 10.1016/j.resuscitation.2005.11.011. Epub 2006 Jun 6. PubMed 16757089 ↗
  • Biccard BM, Madiba TE, Kluyts HL, Munlemvo DM, Madzimbamuto FD, Basenero A, Gordon CS, Youssouf C, Rakotoarison SR, Gobin V, Samateh AL, Sani CM, Omigbodun AO, Amanor-Boadu SD, Tumukunde JT, Esterhuizen TM, Manach YL, Forget P, Elkhogia AM, Mehyaoui RM, Zoumeno E, Ndayisaba G, Ndasi H, Ndonga AKN, Ngumi ZWW, Patel UP, Ashebir DZ, Antwi-Kusi AAK, Mbwele B, Sama HD, Elfiky M, Fawzy MA, Pearse RM; African Surgical Outcomes Study (ASOS) investigators. Perioperative patient outcomes in the African Surgical Outcomes Study: a 7-day prospective observational cohort study. Lancet. 2018 Apr 21;391(10130):1589-1598. doi: 10.1016/S0140-6736(18)30001-1. Epub 2018 Jan 3. PubMed 29306587 ↗
  • 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/S2214-109X(21)00291-6. Epub 2021 Aug 19. PubMed 34418380 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — A pragmatic and realistic dataset is fundamental to the success of the study. Data will be collected on paper on one-day in each hospital plus follow-up censored at 7 day.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: Data will be available from the time of publication and for 10 years following publication.

Access criteria: Contributing researchers and collaborators

Data sharing details ↗ · www.asos.org.za

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06051526
Collaborators
Muhimbili University of Health and Allied Sciences
Responsible party
Bruce Biccard (Co-chief Investigator, University of Cape Town) — Principal investigator
First posted
Sep 25, 2023
Start date
Sep 1, 2023
Primary completion
Jan 3, 2024
Completion
Jan 3, 2024
Last update
Apr 10, 2024

Study contacts

Tim Baker, MBChB; PhD
principal investigator · Muhimbili University of Health and Allied Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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