Epidemiological Characteristics and Outcomes of Patients Admitted to Kenyan Critical Care Units (EPOK). (EPOK)

July 11, 2022 updated by: Nat Intensive Care Surveillance - MORU

Clinical Characteristics and Outcomes of Patients Admitted to Kenyan Critical Care Units During the COVID-19 Pandemic: a Multicenter Registry-based Observational Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background:

The burden of critically ill patients is growing in low and middle income countries (LMICs), but the resources available to assist these patients are limited.1 Critical care is an established and rapidly evolving service in Kenya.2 Yet, patient epidemiological characteristics, patterns of ICU management and patient outcomes in Kenyan ICUs remain scarcely investigated.3,6,7

The ICU registry:

The Kenyan Critical Care Registry was started in December 2020 after receiving ethical approval in November 2020, and currently involves 10 units in 6 Hospitals. The registry was launched in collaboration with the Network for Intensive Care Systems and Training (NICST) and the Mahidol Oxford Research Unit (MORU). As in other countries, the Kenyan Critical Care registry aims to play an increasingly pivotal role in evaluating treatment outcomes, benchmarking services and providing opportunities for service forecasting. Dedicated data collectors in each registry site perform real-time data collection. All registry data is housed and stored securely on a national server located on Kenyan soil. Once entered electronically on password-protected computers at participating facilities, it is automatically encrypted before it leaves the institution for the visualization loop within a ring-fenced server at NICST, where it is unencrypted and aggregated for automated visualization. NICST follows healthcare standard GDP and HIPAA standards. The processed data is then re-encrypted before it is transferred back to the national server, where it is automatically unencrypted and available for review by authorized personnel, through a secure two step log in - a process that is navigated with the help of Kenyan IT teams. An audit trail is created any time the registry is accessed, to see who has logged into it, when, and what data was retrieved or modified.

Study aims:

In this study we aim to describe patient epidemiological characteristics, basic management and outcomes of critically ill patients in Kenya during and after the COVID-19 pandemic, leveraging on the newly-implemented Kenya Critical Care Registry housed under the Critical Care Society of Kenya (CCSK). Study outcomes include clinico-demographic characteristics of patients admitted to critical care units within the Kenya Critical Care Registry network, primary management process measures and short-term critical care outcomes.

Patients:

All patients admitted to participating critical care units from the day of registry onset to the day of database analysis will be included. A secure, non-proprietary, real-time, cloud-based platform designed by NICST, adapted for use at participating facilities when the registry began, is used for data entry and management. A critical care minimum dataset (CCMDS) of variables was employed by the investigators, in consultation with the critical care team at participating facilities.

Ethical Considerations:

Ethical clearance from the Aga Khan University Institutional Ethics Review Committee (IERC) to begin registry creation was obtained in November 2020 (Ref:2019/IERC-89) and a NACOSTI licence secured. Site approvals from NACOSTI-accredited ethical committees and/or administrative clearance were obtained from participating institutions prior to commencement. Ethical/administrative and national regulatory approvals for this present study will be sought in the same manner, prior to study commencement.

Benefits:

There will not be any direct benefit to patients at the outset. The expected improvement in critical care processes and outcomes enabled by the registry data analysis will have the potential to directly benefit future critically ill patients in Kenya. In addition the information gathered on admission, patient flow, occupancy and acuity will be essential to helping Kenyan administrative and management team plan future critical care resource provision, optimising critical care resource utilisation and cost effectiveness. The study may also provide important context specific COVID-19 case-mix and outcome data that may be of value to clinicians, administrators and policy makers during the ongoing pandemic.

Confidentiality:

Access to the electronic registry will be restricted to personnel authorized by the leadership at participating facilities, each of whom have been provided with a unique login and password for this purpose. Each person with such access to the registry has signed a data protection agreement, indicating that they will not share their login details with anyone else, and that they will not share the contents of the registry with unauthorized personnel.

As in other ICU registries, identifiable patient data is restricted to hospital staff authorized to access the critical care registry by the administration of individual facilities.The data extraction for analysis will concern only de-identified data.

Study Type

Observational

Enrollment (Anticipated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU mortality
Time Frame: 1 month
death during ICU or HDU stay
1 month
Length of ICU stay
Time Frame: 1 month
duration of stay in the ICU or HDU in days
1 month
Demographic characteristics
Time Frame: ICU admission
The following demographic characteristics are collected: age, sex
ICU admission
APACHE 2 score
Time Frame: ICU admission
Acute Physiology and Chronic Evaluation 2 score
ICU admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients receiving mechanical ventilation
Time Frame: 1 month
Proportion of patients receiving invasive mechanical ventilation in the ICU or HDU
1 month
Tracheostomy rate
Time Frame: 1 month
Proportion of patients receiving a tracheostomy in the ICU or HDU
1 month
Reason for admission
Time Frame: ICU admission - first 24h
Reason for admission using APACHE IV classification system and SNOMED CT nomenclature
ICU admission - first 24h
Use of vasopressors
Time Frame: ICU admission - first 24h
Use of vasopressors on ICU admission
ICU admission - first 24h
Use of sedatives
Time Frame: ICU admission - first 24h
Use of sedative drugs on ICU admission
ICU admission - first 24h
Use of antibiotics on ICU admission
Time Frame: ICU admission - first 24h
Proportion of patients with at least one antibiotic prescribed on ICU admission
ICU admission - first 24h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nat Intensive Care Surveillance - MORU

Collaborators

Critical Care Society of Kenya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

July 11, 2022

First Submitted That Met QC Criteria

July 11, 2022

First Posted (Actual)

July 13, 2022

Study Record Updates

Last Update Posted (Actual)

July 13, 2022

Last Update Submitted That Met QC Criteria

July 11, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • CCAA-K-1-22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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