SepsisNCT06082154
A Prognostic Model Based on POCUS at ICU Admission in Critically Ill Patients With Sepsis
An observational study of Sepsis, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
Trial summary
Sepsis is responsible for one in three patient deaths. Understanding the severity of the disease, directing medications, prognosticating, and communicating with family members depend on the ability to predict outcomes in a patient presenting with sepsis in the ICU. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- ultrasound
- Type of treatment
- Medical device
- How many people
- 175 participants
- Where
- 1 siteNepal
- Study dates
- 26 Apr 2023to 30 Apr 2024
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient who are diagnosed as having sepsis as per Sepsis 3 definition
Who may be able to join
- Age >=16 yrs within 24 hour of ICU admission diagnosed as Sepsis as per Sepsis 3
Who cannot join
- USG cannot be done within 24 hour of admission to icu If USG cannot be done for 2 parameters Who do not give consent Withdrawal of active life support Do not intubate(DNI) or do not resuscitate(DNR) order at admission
Trial locations and contacts
1 site in 1 country.
About this study
Sepsis is responsible for one in three patient deaths. Understanding the severity of the disease, directing medications, prognosticating, and communicating with family members depend on the ability to predict outcomes in a patient presenting with sepsis in the ICU. The outcome of mortality reflects the caliber of ICU treatment. This is a prospective observational study that will include all patients diagnosed with sepsis for point-of-care ultrasonography within 24 hours of admission to the ICU from April 26, 2023, to March 30, 2024, and create a model that will predict 28 day outcome in these patients.
- Conditions
- Sepsis
- Being tested
- ultrasound
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
Patient will undergo multiorgan ultrasonography
What is being measured
The primary outcome is the main question the study is designed to answer.
28 day status alive or dead
patient will be followed for 28 days from day of icu admission to find out their status being alive or dead
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 posted13 Oct 2023
- Study start26 Apr 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- Prospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashmita Paudel, Tribhuvan University Teaching Hospital, Institute Of Medicine.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082154
- Sponsor's protocol ID
- 506(6-11)E2
- Status last verified
- Aug 2024
- First submitted
- 7 Oct 2023
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prognostic Model Based on POCUS at ICU Admission in Critically Ill Patients With Sepsis
- ClinicalTrials.gov ID
- NCT06082154
- Acronym / sponsor ID
- 506(6-11)E2
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.University, hospital or other
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 13 Oct 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.
Sepsis is responsible for one in three patient deaths. Understanding the severity of the disease, directing medications, prognosticating, and communicating with family members depend on the ability to predict outcomes in a patient presenting with sepsis in the ICU. The outcome of mortality reflects the caliber of ICU treatment. This is a prospective observational study that will include all patients diagnosed with sepsis for point-of-care ultrasonography within 24 hours of admission to the ICU from April 26, 2023, to March 30, 2024, and create a model that will predict 28 day outcome in these patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient who are diagnosed as having sepsis as per Sepsis 3 definition
Key inclusion criteria (1 listed)
- Age >=16 yrs within 24 hour of ICU admission diagnosed as Sepsis as per Sepsis 3
Key exclusion criteria (1 listed)
- USG cannot be done within 24 hour of admission to icu If USG cannot be done for 2 parameters Who do not give consent Withdrawal of active life support Do not intubate(DNI) or do not resuscitate(DNR) order at admission
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 |
|---|---|---|
| ultrasoundPatient will undergo multiorgan ultrasonography | Device | – |
Primary outcome
28 day status alive or dead
Time frame: 28 days
patient will be followed for 28 days from day of icu admission to find out their status being alive or dead
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 2 Aug 2024.
- Individual participant dataSharing planned: No
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Middle East Study of Infections in Patients With Hematological Malignancies
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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 Sepsis, 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 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 2 Aug 2024. 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?
28 day status alive or dead (time frame: 28 days). 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 2 Aug 2024.