Neurologic DisorderNCT06111677
SOFA and APACHE II Scoring Systems for Predicting Outcome of Neurological Patients Admitted in a Tertiary Hospital Intensive Care Unit
An observational study of Neurologic Disorder, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
Trial summary
The aim of this study was to compare the discriminative power of commonly used scoring systems, namely the sequential organ failure assessment (SOFA) and acute physiology and chronic health evaluation II (APACHE II) in the intensive care unit of a tertiary care hospital. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neurologic Disorder
- How many people
- 153 participants
- Where
- 1 siteNepal
- Study dates
- 15 Apr 2023to 1 Sep 2023
- 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: All the patients admitted in ICUs with neurological diagnosis from January 1, 2022 to December 31, 2022
Who may be able to join
- Patients admitted with neurological diagnosis in ICUs
Who cannot join
- Patients with missing data
- Patients with ICU length of stay < 24 h
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to compare the discriminative power of commonly used scoring systems, namely the sequential organ failure assessment (SOFA) and acute physiology and chronic health evaluation II (APACHE II) in the intensive care unit of a tertiary care hospital.
Read the detailed description
This was a retrospective cross-sectional study including patients admitted to the ICU of TU Teaching Hospital with a neurological diagnosis from January 1, 2022, to December 31, 2022. This study uses data collected prospectively as part of the Nepal Intensive Care Research Foundation (NICRF) dataset. The ICU database contained information for all components of the APACHE II and SOFA score with physiological data collected for the length of ICU, and hospital stay. Both SOFA and APACHE II were calculated from the admission data or if not available from the earliest data recorded after admission in ICUs.
- Conditions
- Neurologic Disorder
- Medical subject headings
- Nervous System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
The outcome measure was ICU mortality (survivor vs non-survivor)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start15 Apr 2023
- Primary completion1 Aug 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic DisorderStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sumit Shahi, Tribhuvan University Teaching Hospital, Institute Of Medicine.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111677
- Sponsor's protocol ID
- NeurologicalOutcomeICU
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual particant data was taken from ICU database with deidentified data after taking permission
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOFA and APACHE II Scoring Systems for Predicting Outcome of Neurological Patients Admitted in a Tertiary Hospital Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06111677
- Acronym / sponsor ID
- NeurologicalOutcomeICU
- Conditions
- Neurologic Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.University, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 1 Nov 2023 (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 aim of this study was to compare the discriminative power of commonly used scoring systems, namely the sequential organ failure assessment (SOFA) and acute physiology and chronic health evaluation II (APACHE II) in the intensive care unit of a tertiary care hospital.
Detailed description
This was a retrospective cross-sectional study including patients admitted to the ICU of TU Teaching Hospital with a neurological diagnosis from January 1, 2022, to December 31, 2022. This study uses data collected prospectively as part of the Nepal Intensive Care Research Foundation (NICRF) dataset. The ICU database contained information for all components of the APACHE II and SOFA score with physiological data collected for the length of ICU, and hospital stay. Both SOFA and APACHE II were calculated from the admission data or if not available from the earliest data recorded after admission in ICUs.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the patients admitted in ICUs with neurological diagnosis from January 1, 2022 to December 31, 2022
Key inclusion criteria (1 listed)
- Patients admitted with neurological diagnosis in ICUs
Key exclusion criteria (2 listed)
- Patients with missing data
- Patients with ICU length of stay < 24 h
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
Mortality
Time frame: 1 year
The outcome measure was ICU mortality (survivor vs non-survivor)
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 1 Nov 2023.
- Individual participant dataSharing planned: No. Individual particant data was taken from ICU database with deidentified data after taking permission
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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 Neurologic Disorder, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
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 2 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 1 Nov 2023. 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 Nepal. 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?
Mortality (time frame: 1 year). 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 1 Nov 2023.