PneumoniaNCT04826848
Lactate Clearance in Hospital-acquired Pneumonia
An observational study of Pneumonia and Mortality, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
There is no clear consensus on the use of pneumonia severity index (PSI) developed for community-acquired pneumonia in hospital-acquired pneumonia cases. In another aspect, PSI is a relatively difficult scoring system that includes many parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Lactate
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 1 Dec 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at the age of 18 and over with at least 48 hours of hospitalization within the specified study date range, who were discharged from the hospital within the last 14 days related to this hospitalization, who were re-admitted to the adult emergency department and were diagnosed with pneumonia were included in the study.
Who may be able to join
- 18 and over age, hospital-acquired pneumonia, emergency department admissions
Who cannot join
- Patients who are pregnant or lactating, under 18 years of age, in the healthcare-associated pneumonia group, had mechanical ventilation at the last hospitalization, whose lactate level could not be studied for any reason at admission and 6th hour, had missing data used in pneumonia severity index calculation and/or who did not accept to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt University, School of Medicine, Department of Emergency Medicine
Ankara, Çankaya, 06800
About this study
Official title: The Prognostic Value of Lactate Clearance in Hospital-acquired Pneumonia
There is no clear consensus on the use of pneumonia severity index (PSI) developed for community-acquired pneumonia in hospital-acquired pneumonia cases. In another aspect, PSI is a relatively difficult scoring system that includes many parameters. This study evaluated whether lactate clearance could be used as a mortality marker instead of PSI in hospital-acquired pneumonia. As a result, lactate clearance was lower in the mortal group and when the diagnostic statistics were evaluated, it was seen that the sensitivity and specificity rates were significantly higher. In conclusion, lactate clearance has been evaluated as a strong predictor of mortality in hospital-acquired pneumonia.
- Being tested
- Lactate
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactateDiagnostic test
We will evauate the lactate clearance of the patients in 6 hours period. Lactate clearance = [(Initial lactate - 6th hour lactate) / Initial lactate] * 100
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
28-day mortality
Measured: 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Jun 2019
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alp Şener, MD, Principal investigator, Ankara Yıldırım Beyazıt University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826848
- Sponsor's protocol ID
- LC-HAP
- Status last verified
- Mar 2021
- First submitted
- 30 Mar 2021
- Last updated
- 26 May 2021
- 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 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Value of Lactate Clearance in Hospital-acquired Pneumonia
- ClinicalTrials.gov ID
- NCT04826848
- Acronym / sponsor ID
- LC-HAP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 1 Apr 2021 (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.
There is no clear consensus on the use of pneumonia severity index (PSI) developed for community-acquired pneumonia in hospital-acquired pneumonia cases. In another aspect, PSI is a relatively difficult scoring system that includes many parameters. This study evaluated whether lactate clearance could be used as a mortality marker instead of PSI in hospital-acquired pneumonia. As a result, lactate clearance was lower in the mortal group and when the diagnostic statistics were evaluated, it was seen that the sensitivity and specificity rates were significantly higher. In conclusion, lactate clearance has been evaluated as a strong predictor of mortality in hospital-acquired pneumonia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at the age of 18 and over with at least 48 hours of hospitalization within the specified study date range, who were discharged from the hospital within the last 14 days related to this hospitalization, who were re-admitted to the adult emergency department and were diagnosed with pneumonia were included in the study.
Key inclusion criteria (1 listed)
- 18 and over age, hospital-acquired pneumonia, emergency department admissions
Key exclusion criteria (1 listed)
- Patients who are pregnant or lactating, under 18 years of age, in the healthcare-associated pneumonia group, had mechanical ventilation at the last hospitalization, whose lactate level could not be studied for any reason at admission and 6th hour, had missing data used in pneumonia severity index calculation and/or who did not accept to participate in 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LactateWe will evauate the lactate clearance of the patients in 6 hours period. Lactate clearance = [(Initial lactate - 6th hour lactate) / Initial lactate] * 100 | Diagnostic test | – |
Primary outcome
Mortality
Time frame: 28 day
28-day mortality
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 26 May 2021.
- 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.
Alp Şener, MD principal investigator
Ankara Yıldırım Beyazıt University Faculty of Medicine
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 Pneumonia and Mortality, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 26 May 2021. 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 Turkey (Türkiye). 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: 28 day). 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 26 May 2021.