Critical IllnessNCT03511742
Functional ICUS in Uganda and Their Survival Outcomes
An observational study of Critical Illness, run by Makerere University at 1 site in Uganda.
Trial summary
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Illness
- How many people
- 367 participants
- Where
- 1 siteUganda
- Study dates
- 8 Jan 2018to 30 Apr 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- All new patients admitted to Uganda's Intensive Care Units ICUs in Uganda whose unit heads verbally consent to participate in the study.
Who cannot join
- Patients transferred in from another unit will not be re recruited. ICUs that don't consent to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Critical Illness
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start8 Jan 2018
- Primary completion30 Apr 2018 (estimated)
- Study completion30 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- 367 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, College of Health Sciences, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511742
- Sponsor's protocol ID
- #REC REF 2018-004
- Status last verified
- Apr 2018
- First submitted
- 10 Apr 2018
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: analyses data will be published in a peer reviewed journal
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Characteristics of ICUs in Uganda and Their 28-day Patient Mortality
- ClinicalTrials.gov ID
- NCT03511742
- Acronym / sponsor ID
- #REC REF 2018-004
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 367 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 30 Apr 2018 (estimated)
- Study completion
- 30 Apr 2018 (estimated)
- First posted
- 30 Apr 2018 (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.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All new patients admitted to Uganda's Intensive Care Units ICUs in Uganda whose unit heads verbally consent to participate in the study.
Key exclusion criteria (1 listed)
- Patients transferred in from another unit will not be re recruited. ICUs that don't consent to the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
28 day mortality
Time frame: 3 months
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
functional characteristics of ICUs in Uganda
Time frame: 3 months
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
1 secondary outcome
factors associated with mortality
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
- Individual participant dataSharing planned: Yes. analyses data will be published in a peer reviewed journal
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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 Critical Illness, run by Makerere University at 1 site in Uganda.
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 1 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: status not confirmed, as of the sponsor's last update on 30 Apr 2018. 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 Uganda. 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?
Results are not available in the source record.
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?
28 day mortality (time frame: 3 months). 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?
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 30 Apr 2018.