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| Name | Class |
|---|---|
| Muhimbili University of Health and Allied Sciences | OTHER |
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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.
STUDY OBJECTIVES
The objectives of this study are to determine:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Critically ill in-patients | All adult inpatients in hospitals across Africa that are critically ill. |
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| Measure | Description | Time Frame |
|---|---|---|
| Presence of critical illness | The number of participants with critical illness. | 7 days |
| In-hospital mortality (censored at 7-days) | The number of participants with in-hospital mortality (censored at 7-days) | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Provision of essential emergency and critical care | To number of critically ill patients who receive essential emergency and critical care. | 7 days |
| Length of hospital stay | The length of hospital stay for critically ill patients |
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Inclusion Criteria:
Exclusion Criteria:
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All adult patients aged 18 years or over who have been admitted for inpatient care in any department or ward in participating hospitals.
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| Name | Affiliation | Role |
|---|---|---|
| Tim Baker, MBChB; PhD | Muhimbili University of Health and Allied Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merowe Daman Hospital | Khartoum | Sudan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36606666 | Result | 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. | |
| 28263204 | Result | 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. |
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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.
Data will be available from the time of publication and for 10 years following publication.
Contributing researchers and collaborators
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 17, 2023 | Feb 26, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Main study statistical analysis plan | Feb 13, 2024 | Feb 26, 2024 | SAP_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Pain substudy statistical analysis plan | Apr 8, 2024 | Apr 8, 2024 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 7 days |
| Number of essential emergency and critical care resources available for care | The number of essential emergency and critical care resources available | 7 days |
| 26986466 | Result | 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. |
| 31923030 | Result | 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. |
| 26070457 | Result | 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. |
| 32733655 | Result | 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. |
| 23590288 | Result | 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. |
| 34506504 | Result | 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. |
| 30373648 | Result | 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. |
| 36670506 | Result | 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. |
| 36716353 | Result | 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. |
| 36162903 | Result | 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. |
| 31954465 | Result | 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. |
| 26635210 | Result | 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. |
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| 22546146 | Result | 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. |
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| 34022988 | Result | 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. |
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| 26154933 | Result | 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. |
| 28935477 | Result | 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. |
| 27799174 | Result | 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. |
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| 26693728 | Result | 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. |
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| 34418380 | Result | 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. |