Functional ICUS in Uganda and Their Survival Outcomes

Functional Characteristics of ICUs in Uganda and Their 28-day Patient Mortality

Aim of the study is to describe the functional characteristics of Icus in Uganda and their @8-day patient characteristics it is a prospective cohort study .All Icus in Uganda will be included and their admitted patients followed upto 28 days in the ICU for mortality

Study Overview

• Status: Unknown
• Conditions: Critical Illness

Detailed Description

Intensive Care units are specialized units with expertise to provide organ support for the critically ill patients. There's a growing global burden of critical illness especially in the low-income coun-tries where critical care services are limited. Despite advances in critical care, the mortality in Uganda remains very high, with sepsis and trauma as the major contributors. There's paucity of literature regarding ICUs characteristics, disease burden and patient characteristics which could be contributing to the high mortality.

Objectives To describe the functional characteristics of the ICUs in Uganda. To determine the ICU mortality of critically ill patients in Uganda. To determine the risk factors of mortality of patients admitted in the ICU Methods A prospective cohort study will be carried out in all ICUs in Uganda. All new patients in the ICUs will be recruited into the study. Data will be collected onto two separate questionnaires, one for patient characteristics and the second for ICU functional characteristics. The patient's data will be collected within the first 24 hours and patients will be followed up for death\discharge within 28 days in the ICU. The data will be collected from the patients' charts and entered into Epidata.

• Study Type: Observational
• Enrollment (Anticipated): 367

Contacts and Locations

Study Locations

• Uganda
  • Kampala, Uganda, 256
    • Atumanya Patience

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Target population Critically ill patients in all Intensive care units in Uganda Accessible population. All ICUs in Uganda. All patients admitted to the intensive care units in Uganda during the study period.

Description

Inclusion Criteria:

All new patients admitted to Uganda's Intensive Care Units ICUs in Uganda whose unit heads verbally consent to participate in the study.

Exclusion Criteria:

Patients transferred in from another unit will not be re recruited. ICUs that don't consent to the study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28 day mortality	Total number of patients who died during the study period within 28 days over the total number recruited, and a survival analysis will be plowed on a Kaplan Meier	3 months
functional characteristics of ICUs in Uganda	outcome measure will be descriptive, that is interms of ICU location(urban or rural), staffing (nurse to patient ratio), infrastructure(floor space cm2), monitoring equipment, services rendered(organ support), and the ICU operation models(closed versus open) will be assessed for association with patient outcome	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
factors associated with mortality	Age ( years), sex, indication for admission, length of ICU stay(days), comorbidities, HIV and HAART status, Mechanical ventilation(days) and length on ICU stay(days), ICU final diagnosis, Ino-tropic/vasopressor use, Sedation, NEWS score will be run in univariate and multivariate to assess association with mortality.	3 months

Collaborators and Investigators

• Sponsor: Makerere University

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2018
• Primary Completion (Anticipated): April 30, 2018
• Study Completion (Anticipated): April 30, 2018

Study Registration Dates

• First Submitted: April 10, 2018
• First Submitted That Met QC Criteria: April 26, 2018
• First Posted (Actual): April 30, 2018

Study Record Updates

• Last Update Posted (Actual): April 30, 2018
• Last Update Submitted That Met QC Criteria: April 26, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: #REC REF 2018-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: analyses data will be published in a peer reviewed journal
• IPD Sharing Time Frame: within 6 months
• IPD Sharing Access Criteria: open access
• IPD Sharing Supporting Information Type: SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No