NCT05456217

Brief Summary

The Kenyan Critical Care Registry was started in December 2020 and currently involves 10 critical care units in 6 Hospitals. As an initial registry output, we aim to describe patient epidemiological characteristics, initial management and outcomes of critically ill patients in Kenya. This project will provide a much-needed source of clinico-demographic and outcomes data for participating Kenyan critical care units. It will also help to identify processes and outcomes which can be targeted by quality improvement projects, the impact of which can then be evaluated later using the registry.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

July 13, 2022

Status Verified

July 1, 2022

Enrollment Period

1.6 years

First QC Date

July 11, 2022

Last Update Submit

July 11, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • ICU mortality

    death during ICU or HDU stay

    1 month

  • Length of ICU stay

    duration of stay in the ICU or HDU in days

    1 month

  • Demographic characteristics

    The following demographic characteristics are collected: age, sex

    ICU admission

  • APACHE 2 score

    Acute Physiology and Chronic Evaluation 2 score

    ICU admission

Secondary Outcomes (6)

  • Patients receiving mechanical ventilation

    1 month

  • Tracheostomy rate

    1 month

  • Reason for admission

    ICU admission - first 24h

  • Use of vasopressors

    ICU admission - first 24h

  • Use of sedatives

    ICU admission - first 24h

  • +1 more secondary outcomes

Interventions

admission to an intensive care unit or high dependency unit in Kenya

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients admitted to ICUs or HDUs participating in the Kenya Critical Care registry

You may qualify if:

  • Admitted to an intensive care unit or high dependency unit
  • Included in the Kenya Critical Care registry platform

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Kisii County Hospital

Kisii, Kenya

RECRUITING

Mombasa Aga Khan Hospital

Mombasa, Kenya

RECRUITING

Aga Khan University Hospital

Nairobi, Kenya

RECRUITING

MP Shah Hospital

Nairobi, Kenya

RECRUITING

Nakuru level V Hospital

Nakuru, Kenya

RECRUITING

Nyeri County Hospital

Nyeri, Kenya

RECRUITING

Related Publications (2)

  • Pisani L, Waweru-Siika W, Sendagire C, Beane A, Haniffa R. Critically ill COVID-19 patients in Africa: it is time for quality registry data. Lancet. 2021 Aug 7;398(10299):485-486. doi: 10.1016/S0140-6736(21)01549-X. No abstract available.

    PMID: 34364515BACKGROUND
  • Njoki C, Simiyu N, Kaddu R, Mwangi W, Sulemanji D, Oduor P, Dona DG, Otieno D, Abonyo TT, Wangeci P, Kabanya T, Mutuku S, Kioko A, Muthoni J, Kamau PM, Beane A, Haniffa R, Dondorp A, Misango D, Pisani L, Waweru-Siika W. EPidemiology, clinical characteristics and Outcomes of 4546 adult admissions to high-dependency and intensive care units in Kenya (EPOK): a multicentre registry-based observational study. Crit Care Explor. 2024 Feb 1;6(2):e1036. doi: 10.1097/CCE.0000000000001036. eCollection 2024 Feb 1.

Central Study Contacts

Wangari Siika, Prof.

CONTACT

Carolyne Njoki, Dr

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2022

First Posted

July 13, 2022

Study Start

January 1, 2021

Primary Completion

August 1, 2022

Study Completion

September 1, 2022

Last Updated

July 13, 2022

Record last verified: 2022-07

Locations