Clinical OutcomesPDCONCT05303831
Pattern of Disease and Determinants of Clinical Outcomes Among ICU Patients
An observational study of Clinical Outcomes, run by Dilla University at 1 site in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Clinical Outcomes
- What is being tested?
- Mechanical ventilator
- How many people
- 630 participants
- Where
- 1 siteEthiopia
- Study dates
- 4 Apr 2022to 20 Sep 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All Adult patients who are on Mechanical ventilator in Dilla University referral hospital, Wolaita Sodo University Hospital, and Hawassa University specialized Hospital ICUs during the study period
Who may be able to join
None listed.
Who cannot join
- Patients admitted to ICU on re-admission and patients with no attendants will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pattern of Disease and Determinants of Clinical Outcomes Among ICU Patients on Mechanical Ventilator in Southern Ethiopia: A Multi-center Prospective Cohort Study
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.
Read the 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
- Being tested
- Mechanical ventilator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ventilatorOther
patients on a mechanical ventilators in ICU will be followed for 28-days for clinical outcomes
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of mortality
The incidence of mortality of patients in the ICU who are on Mechanical ventilator during 28-days follow up
Measured: 28-days
time to death
The time with which patients die during follow up
Measured: 28-days
Secondary outcomes (3)
time to wean from the MV
This refers to the time when patients weaned from the MV
Measured: 28-days
time to develop adverse events
The time with which patients develop complications during follow up such as cardiac arrest, ventilator associated Pneumonia etc.
Measured: 28-days
Incidence of prolonged ventilation
This study intends to investigate how many of patients are on mechanical ventilator for prolonged period during follow up as per the criteria of prolonged MV
Measured: 28-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start4 Apr 2022
- Primary completion29 Aug 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clinical OutcomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 630 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Dilla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semagn Mekonnen, Dilla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303831
- Sponsor's protocol ID
- duirb/001/21-08
- Acronym
- PDCO
- Status last verified
- Dec 2022
- First submitted
- 21 Mar 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36694238
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Disease and Determinants of Clinical Outcomes Among ICU Patients on Mechanical Ventilator in Southern Ethiopia: A Multi-center Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05303831
- Acronym / sponsor ID
- PDCO / duirb/001/21-08
- Conditions
- Clinical Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 630 participants (actual)
- Lead sponsor
- Dilla UniversityUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 29 Aug 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All Adult patients who are on Mechanical ventilator in Dilla University referral hospital, Wolaita Sodo University Hospital, and Hawassa University specialized Hospital ICUs during the study period
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Patients admitted to ICU on re-admission and patients with no attendants will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical ventilatorpatients on a mechanical ventilators in ICU will be followed for 28-days for clinical outcomes | Other | – |
Primary outcome
Incidence of mortality
Time frame: 28-days
The incidence of mortality of patients in the ICU who are on Mechanical ventilator during 28-days follow up
time to death
Time frame: 28-days
The time with which patients die during follow up
3 secondary outcomes
time to wean from the MV
Time frame: 28-days
time to develop adverse events
Time frame: 28-days
Incidence of prolonged ventilation
Time frame: 28-days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Derived from this study: PubMed 36694238Abate 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Outcomes, run by Dilla University at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of mortality (time frame: 28-days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05303831, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.