Out-Of-Hospital Cardiac ArrestNCT04571281
Dynamics of the Capillary Lactate Levels in OHCA
An observational study of Out-Of-Hospital Cardiac Arrest, run by University Medical Centre Maribor at 1 site in Slovenia.
Trial summary
Serial capillary lactate measurements during cardiopulmonary resuscitation (CPR) in patients with out-of-hospital cardiac arrest (OHCA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest
- What is being tested?
- capillary lactate measurements
- How many people
- 100 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Apr 2019to 31 May 2022
- 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: For this study will be eligible all patients with OHCA due to primary or secondary cardiac arrest.
Who may be able to join
- adults with OHCA
Who cannot join
- children with OHCA
- trauma
- hypothermia
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
Community health center Maribor, Prehospital unit
Maribor, 2000
About this study
Official title: Dynamics of the Capillary Lactate Levels in Patients With Out-of-hospital Cardiac Arrest
Serial capillary lactate measurements during cardiopulmonary resuscitation (CPR) in patients with out-of-hospital cardiac arrest (OHCA).
Read the detailed description
Capillary lactate measurements will be measured every ten minutes during CPR in OHCA.
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Being tested
- capillary lactate measurements
- Keywords
- Out-Of-Hospital Cardiac Arrest, lactic acid, Cardiopulmonary resuscitation, Survival
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capillary lactate measurementsDiagnostic test
In this study capillary lactate will be measured every 10 minute during CPR.
What is being measured
The primary outcome is the main question the study is designed to answer.
ROSC
In patients with ROSC the capillary lactate level will be lower compare to the non ROSC group.
Measured: 2 years
Comparison between primary and secondary cardiac arrest
Initial and serial values of capillary lactate will be lower in patients with primary out-of- hospital cardiac arrest (OHCA)
Measured: 2 years
No ROSC
Serial values of capillary lactate will be higher in patients without ROSC
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start1 Apr 2019
- Primary completion31 Dec 2021
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Maribor
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matej Strnad, University Medical Centre Maribor
- Investigators
- Matej Strnad, MD, PhD, Study director, University medical center Maribor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571281
- Sponsor's protocol ID
- KME 0120-229/2018/12
- Status last verified
- Nov 2023
- First submitted
- 24 Sep 2020
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lurie KG, Nemergut EC, Yannopoulos D, Sweeney M. The Physiology of Cardiopulmonary Resuscitation. Anesth Analg. 2016 Mar;122(3):767-783. doi: 10.1213/ANE.0000000000000926.
PubMed 26562060Patil KD, Halperin HR, Becker LB. Cardiac arrest: resuscitation and reperfusion. Circ Res. 2015 Jun 5;116(12):2041-9. doi: 10.1161/CIRCRESAHA.116.304495.
PubMed 26044255Corral Torres E, Hernandez-Tejedor A, Suarez Bustamante R, de Elias Hernandez R, Casado Florez I, San Juan Linares A. Prognostic value of venous blood analysis at the start of CPR in non-traumatic out-of-hospital cardiac arrest: association with ROSC and the neurological outcome. Crit Care. 2020 Feb 22;24(1):60. doi: 10.1186/s13054-020-2762-5.
PubMed 32087761Sariaydin T, Corbacioglu SK, Cevik Y, Emektar E. Effect of initial lactate level on short-term survival in patients with out-of-hospital cardiac arrest. Turk J Emerg Med. 2017 May 15;17(4):123-127. doi: 10.1016/j.tjem.2017.05.003. eCollection 2017 Dec.
PubMed 29464213
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamics of the Capillary Lactate Levels in Patients With Out-of-hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT04571281
- Acronym / sponsor ID
- KME 0120-229/2018/12
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Keywords
- Out-Of-Hospital Cardiac Arrest, lactic acid, Cardiopulmonary resuscitation, Survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Medical Centre MariborUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 1 Oct 2020 (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.
Serial capillary lactate measurements during cardiopulmonary resuscitation (CPR) in patients with out-of-hospital cardiac arrest (OHCA).
Detailed description
Capillary lactate measurements will be measured every ten minutes during CPR in OHCA.
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
- For this study will be eligible all patients with OHCA due to primary or secondary cardiac arrest.
Key inclusion criteria (1 listed)
- adults with OHCA
Key exclusion criteria (3 listed)
- children with OHCA
- trauma
- hypothermia
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 |
|---|---|---|
| capillary lactate measurementsIn this study capillary lactate will be measured every 10 minute during CPR. | Diagnostic test | – |
Primary outcome
ROSC
Time frame: 2 years
In patients with ROSC the capillary lactate level will be lower compare to the non ROSC group.
Comparison between primary and secondary cardiac arrest
Time frame: 2 years
Initial and serial values of capillary lactate will be lower in patients with primary out-of- hospital cardiac arrest (OHCA)
No ROSC
Time frame: 2 years
Serial values of capillary lactate will be higher in patients without ROSC
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 24 Nov 2023.
- Background: PubMed 26562060Lurie KG, Nemergut EC, Yannopoulos D, Sweeney M. The Physiology of Cardiopulmonary Resuscitation. Anesth Analg. 2016 Mar;122(3):767-783. doi: 10.1213/ANE.0000000000000926.
- Background: PubMed 26044255Patil KD, Halperin HR, Becker LB. Cardiac arrest: resuscitation and reperfusion. Circ Res. 2015 Jun 5;116(12):2041-9. doi: 10.1161/CIRCRESAHA.116.304495.
- Background: PubMed 32087761Corral Torres E, Hernandez-Tejedor A, Suarez Bustamante R, de Elias Hernandez R, Casado Florez I, San Juan Linares A. Prognostic value of venous blood analysis at the start of CPR in non-traumatic out-of-hospital cardiac arrest: association with ROSC and the neurological outcome. Crit Care. 2020 Feb 22;24(1):60. doi: 10.1186/s13054-020-2762-5.
- Background: PubMed 29464213Sariaydin T, Corbacioglu SK, Cevik Y, Emektar E. Effect of initial lactate level on short-term survival in patients with out-of-hospital cardiac arrest. Turk J Emerg Med. 2017 May 15;17(4):123-127. doi: 10.1016/j.tjem.2017.05.003. eCollection 2017 Dec.
- 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.
Matej Strnad, MD, PhD study director
University medical center Maribor
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 Out-Of-Hospital Cardiac Arrest, run by University Medical Centre Maribor at 1 site in Slovenia.
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 3 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 24 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 Slovenia. 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?
ROSC (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04571281, which also lists 4 linked publications.
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 24 Nov 2023.