Acute Pulmonary Embolism (PE)PRAGUE-PENCT06583616
The Prognostic Value of Anion Gap in Predicting Mortality Among Patients With Acute Pulmonary Embolism
An observational study of Acute Pulmonary Embolism (PE), run by Universitas Diponegoro at 1 site in Indonesia.
Trial summary
This study aims to evaluate the prognostic value of the anion gap in predicting mortality among patients with acute pulmonary embolism. Researchers will collect information based on hospital registry as secondary data of in patient who had diagnosed as acute pulmonary embolism by using computed tomography scan (CT… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Pulmonary Embolism (PE)
- What is being tested?
- Anion Gap
- How many people
- 20 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2023to 30 Sep 2024
- How long will I take part?
- 7 Days
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient with acute pulmonary embolism
Who may be able to join
- age: 18 - 70 years old
- patient with acute pulmonary embolism
Who cannot join
- heart failure
- valvular heart disease
- chronic obstructive pulmonary disease
- congenital heart disease
- sepsis
- chronic kidney disease
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Dr. Kariadi Central General Hospital
Semarang, Central of Java
Leo Deddy Pradipta, +62 81316499074, dancingdeagle@gmail.com
About this study
This study aims to evaluate the prognostic value of the anion gap in predicting mortality among patients with acute pulmonary embolism.
Researchers will collect information based on hospital registry as secondary data of in patient who had diagnosed as acute pulmonary embolism by using computed tomography scan (CT scan). The data consist of demographic data, clinical presentation, laboratory, and CT scan were collected from hospital registry by reviewing medical record. Then, the data was analyzed by using IBM SPSS Statistics v26.
- Conditions
- Acute Pulmonary Embolism (PE)
- Being tested
- Anion Gap
- Keywords
- anion gap, acute pulmonary embolism, mortality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anion GapDiagnostic test
Patient with acute pulmonary embolism who not survive after hospitalization
| Study group | Role | What they receive |
|---|---|---|
| Survival Group | Patient with acute pulmonary embolism who survive after hospitalization Receives: Diagnostic Test: Anion Gap |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Measured: During hospitalization, up to 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start1 Jan 2023
- Primary completion31 Aug 2024
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pulmonary Embolism (PE)Studies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Universitas Diponegoro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sodiqur Rifqi, Universitas Diponegoro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583616
- Sponsor's protocol ID
- Undip_Kardio_1
- Acronym
- PRAGUE-PE
- Status last verified
- Sep 2024
- First submitted
- 30 Aug 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Value of Anion Gap in Predicting Mortality Among Patients With Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT06583616
- Acronym / sponsor ID
- PRAGUE-PE / Undip_Kardio_1
- Conditions
- Acute Pulmonary Embolism (PE)
- Keywords
- anion gap, acute pulmonary embolism, mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitas DiponegoroUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 4 Sep 2024 (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.
This study aims to evaluate the prognostic value of the anion gap in predicting mortality among patients with acute pulmonary embolism.
Researchers will collect information based on hospital registry as secondary data of in patient who had diagnosed as acute pulmonary embolism by using computed tomography scan (CT scan). The data consist of demographic data, clinical presentation, laboratory, and CT scan were collected from hospital registry by reviewing medical record. Then, the data was analyzed by using IBM SPSS Statistics v26.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Survival Group | – | Diagnostic Test: Anion GapPatient with acute pulmonary embolism who survive after hospitalization |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with acute pulmonary embolism
Key inclusion criteria (2 listed)
- age: 18 - 70 years old
- patient with acute pulmonary embolism
Key exclusion criteria (6 listed)
- heart failure
- valvular heart disease
- chronic obstructive pulmonary disease
- congenital heart disease
- sepsis
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 |
|---|---|---|
| Anion GapPatient with acute pulmonary embolism who not survive after hospitalization | Diagnostic test | Survival Group |
Primary outcome
In-hospital mortality
Time frame: During hospitalization, up to 1 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Individual participant dataSharing planned: No
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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.
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 Acute Pulmonary Embolism (PE), run by Universitas Diponegoro at 1 site in Indonesia.
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 2 inclusion and 6 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 4 Sep 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 Indonesia. 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?
Contact Leo Deddy Pradipta, MD (+6281316499074, dancingdeagle@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: During hospitalization, up to 1 weeks). 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 4 Sep 2024.