Pattern of Disease and Determinants of Clinical Outcomes Among ICU Patients

NCT ID: NCT05303831

Last Updated: 2022-12-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 630 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-04
• Study Completion Date: 2022-09-20

Brief Summary

The global mortality rate of patients on MV is very high which is varied with the income level of the country, duration of a mechanical ventilator, the pattern of disease, ICU staff profile, availability of medical supplies. All Studies conducted so far in Sub-Saharan Africa including Ethiopia among ICU patients primarily focused on the pattern of admission, the incidence of mortality, and its determinants. However, the body of evidence on the pattern of disease, the incidence of MV, and determinants of mortality among patients on MV is still uncertain and a topic of debate nationally as well as locally.

Therefore, A multicenter prospective cohort study is planned to be carried out in Southern Ethiopia Teaching and referral hospital ICUs.

Detailed Description

Introduction: The global mortality rate of patients on MV is very high which is varied with the income level of the country, duration of a mechanical ventilator, the pattern of disease, ICU staff profile, availability of medical supplies. All Studies conducted so far in Sub-Saharan Africa including Ethiopia among ICU patients primarily focused on the pattern of admission, the incidence of mortality, and its determinants. However, the body of evidence on the pattern of disease, the incidence of MV, and determinants of mortality among patients on MV is still uncertain and a topic of debate nationally as well as locally.

Objective: The general objective of the study is to investigate the pattern of disease and determinants of mortality among ICU patients on Mechanical ventilators in Southern Ethiopia from April 2021 to September 2022.

Methods: After obtaining Ethical clearance from Research Ethics Committee (IRB), a multi-center cohort study will be conducted in three teaching and referral hospitals in Southern Ethiopia; namely, Hawassa university referral hospital (HURH), Dilla University referral hospital (DURH), and Wolaita Sodo referral hospital (WURH) from March 2021, to September 2022. Four Hundred Forty-four consecutive Adult patients who will be on a mechanical ventilator in ICU fulfilling the inclusion criteria and will be followed for 28-days to assess the pattern of disease, survival status and determinants of mortality will be included. Data will be entered into Statistical Package for Social Sciences version 22 for analysis. Descriptive statistics will be run to see the overall distribution of the study subjects concerning the variables under study. Chi-square test and odds ratio will be used to determine the association between hypothesized independent and dependent variables. Multivariate analysis will be conducted to control possible confounders and identify independent predictors of length of ICU stay and 28- days mortality. Survival analysis and Cox regression will be done to estimate the probability of dying within 28 days and time to wean from a mechanical ventilator.

Conditions

Clinical Outcomes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Mechanical ventilator

patients on a mechanical ventilators in ICU will be followed for 28-days for clinical outcomes

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

• Patients admitted to ICU on re-admission and patients with no attendants will be excluded.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dilla University

OTHER

Sponsor Role: lead

Responsible Party

Semagn Mekonnen

Assistant professor, thematic research leader

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dilla University

Addis Ababa, , Ethiopia

Countries

Ethiopia

References

Abate SM, Basu B, Jemal B, Ahmed S, Mantefardo B, Taye T. Pattern of disease and determinants of mortality among ICU patients on mechanical ventilator in Sub-Saharan Africa: a multilevel analysis. Crit Care. 2023 Jan 24;27(1):37. doi: 10.1186/s13054-023-04316-w.

Reference Type: DERIVED

PMID: 36694238 (View on PubMed)

Other Identifiers

duirb/001/21-08

Identifier Type: -

Identifier Source: org_study_id