Cardiac ArrestReCappNCT04791995
Resuscitation and Capillary Reperfusion
An observational study of Cardiac Arrest and Cardiac Arrest, Out-Of-Hospital, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Persistent microperfusion alterations after return of spontaneous circulation (ROSC) are associated with poor survival. To our knowledge, no human studies evaluating microperfusion during cardiopulmonary resuscitation (CPR) with simple and pre-hospital available tests have been published. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Cardiac Arrest, Cardiac Arrest, Out-Of-Hospital, Cardiopulmonary Arrest
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 3 Mar 2021to 1 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult out-of-hospital cardiac arrest patients
Who may be able to join
- All patients ≥18 years during cardiopulmonary resuscitation
- witnessed cardiac arrest
Who cannot join
- insufficient manpower (e.g. study team has to provide CPR)
- hypovolemia (exsanguination, anaphylaxis, sepsis as underlying cause)
- presumed or known COVID-19 disease
- hypo-/hyperthermia (<36.0°, >37.5°C)
- Raynaud's disease
- Peripheral arterial disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: REsuscitation and CAPillary rePerfusion - A Cohort Study With Prospective Inclusion
Persistent microperfusion alterations after return of spontaneous circulation (ROSC) are associated with poor survival. To our knowledge, no human studies evaluating microperfusion during cardiopulmonary resuscitation (CPR) with simple and pre-hospital available tests have been published. Capillary refill time (CRT) and skin-mottling-score (SMS) are parameters for microperfusion and evaluated in septic and cardiogenic shock. In animal studies, microperfusion was impaired during cardiac arrest, although not correlating with systemic blood pressure.
The aim of this study is to investigate the correlation between impaired microcirculation (as measured with CRT and SMS) during resuscitation and ROSC resp. neurological outcome. Our clinical impression in daily routine is, that the appearance of a patient undergoing CPR is often linked to the outcome. We hypothesize, that this is due to changes in microperfusion of the skin.
- Conditions
- Cardiac Arrest, Cardiac Arrest, Out-Of-Hospital, Cardiopulmonary Arrest, Cardiopulmonary Arrest With Successful Resuscitation
- Keywords
- capillary refill time, skin mottling score, capillary lactate, microperfusion, cardiopulmonary resuscitation
- Medical subject headings
- Heart Arrest, Out-of-Hospital Cardiac Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
Capillary refill time (CRT)
Capillary refill time in seconds measured on one finger and one earlobe for ROSC vs. no ROSC
Measured: baseline (immediately after inclusion to the study)
Secondary outcomes (10)
Skin mottling score (SMS)
Skin mottling score (Ait-Oufella, H., Lemoinne, S., Boelle, P.Y. et al. Mottling score predicts survival in septic shock. Intensive Care Med 37, 801-807 (2011). Best: 0 - no mottling to worst: 5 - mottling on the entire leg) for ROSC vs. noROSC
Measured: baseline (immediately after inclusion to the study = minute 0), minute 2, 4, 6, 8, (...) up to return of spontaneous circulation or death, whichever came first
Capillary blood lactate (Lac)
Capillary lactate in mmol/L from the capillary bed of a finger for ROSC vs noROSC and for correlations with CRT, SMS
Measured: baseline (immediately after inclusion to the study, = minute 0), minute 4, 8, 12, 16, 20
Hospital mortality
Correlation of CRT, SMS and Lac with hospital mortality
Measured: baseline (immediately after inclusion to the study)
Correlation of CRT, SMS and Lac and 30 days good neurological outcome
Good neurological outcome at 30 days measured with Cerebral Performance Category (CPC 1-5 (1 best: good cerebral performance, 5 worst: brain dead), modified Rankin scale (mRs 0-6 (0 best: no symptoms, 6 worst: dead) and health utility index 3 (HUI-3, worst: -0,36 - best: 1)
Measured: baseline (immediately after inclusion to the study)
Correlation of CRT, SMS and Lac and hospital discharge good neurological outcome
Good neurological outcome at hospital discharge measured with Cerebral Performance Category (CPC 1-5 (1 best: good cerebral performance, 5 worst: brain dead), modified Rankin scale (mRs 0-6 (0 best: no symptoms, 6 worst: dead) and health utility index 3 (HUI-3, worst: -0,36 - best: 1)
Measured: baseline (immediately after inclusion to the study)
Correlation of CRT/SMS and lactate
Correlation of CRT/SMS and lactate
Measured: baseline (immediately after inclusion to the study)
Correlation of SMS and CRT
Correlation of SMS and CRT
Measured: baseline (immediately after inclusion to the study)
Correlation of time since cardiac arrest and CRT/SMS/lactate
Correlation of time since cardiac arrest and CRT/SMS/lactate
Measured: baseline (immediately after inclusion to the study)
Correlation of catecholamine demand during the first 48 hours after ROSC and CRT/SMS
Cumulative catecholamine demand during the first 48 hours after ROSC in correlation with CRT/SMS/Lac during resuscitation
Measured: from ROSC up to 48 hours after ROSC
Capillary refill time (CRT)
Capillary refill time in seconds measured on one finger and one earlobe for ROSC vs. no ROSC
Measured: minute 2, 4, 6, 8, (...) up to return of spontaneous circulation or death, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start3 Mar 2021
- Primary completion31 Mar 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Holzer, Medical University of Vienna
- Investigators
- Michael Holzer, MD, Principal investigator, Department of Emergency Medicine, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791995
- Sponsor's protocol ID
- 001
- Acronym
- ReCapp
- Status last verified
- Sep 2022
- First submitted
- 2 Mar 2021
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mueller M, Holzer M, Losert H, Grassmann D, Ettl F, Gatterbauer M, Magnet I, Nuernberger A, Kienbacher CL, Gelbenegger G, Girsa M, Herkner H, Krammel M. The association of capillary refill time and return of spontaneous circulation during out-of-hospital cardiac arrest: an observational study. Crit Care. 2025 Jan 21;29(1):37. doi: 10.1186/s13054-025-05255-4.
PubMed 39838473
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REsuscitation and CAPillary rePerfusion - A Cohort Study With Prospective Inclusion
- ClinicalTrials.gov ID
- NCT04791995
- Acronym / sponsor ID
- ReCapp / 001
- Conditions
- Cardiac Arrest, Cardiac Arrest, Out-Of-Hospital, Cardiopulmonary Arrest, Cardiopulmonary Arrest With Successful Resuscitation
- Keywords
- capillary refill time, skin mottling score, capillary lactate, microperfusion, cardiopulmonary resuscitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 10 Mar 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.
Persistent microperfusion alterations after return of spontaneous circulation (ROSC) are associated with poor survival. To our knowledge, no human studies evaluating microperfusion during cardiopulmonary resuscitation (CPR) with simple and pre-hospital available tests have been published. Capillary refill time (CRT) and skin-mottling-score (SMS) are parameters for microperfusion and evaluated in septic and cardiogenic shock. In animal studies, microperfusion was impaired during cardiac arrest, although not correlating with systemic blood pressure.
The aim of this study is to investigate the correlation between impaired microcirculation (as measured with CRT and SMS) during resuscitation and ROSC resp. neurological outcome. Our clinical impression in daily routine is, that the appearance of a patient undergoing CPR is often linked to the outcome. We hypothesize, that this is due to changes in microperfusion of the skin.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult out-of-hospital cardiac arrest patients
Key inclusion criteria (2 listed)
- All patients ≥18 years during cardiopulmonary resuscitation
- witnessed cardiac arrest
Key exclusion criteria (6 listed)
- insufficient manpower (e.g. study team has to provide CPR)
- hypovolemia (exsanguination, anaphylaxis, sepsis as underlying cause)
- presumed or known COVID-19 disease
- hypo-/hyperthermia (<36.0°, >37.5°C)
- Raynaud's disease
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
Capillary refill time (CRT)
Time frame: baseline (immediately after inclusion to the study)
Capillary refill time in seconds measured on one finger and one earlobe for ROSC vs. no ROSC
10 secondary outcomes
Skin mottling score (SMS)
Time frame: baseline (immediately after inclusion to the study = minute 0), minute 2, 4, 6, 8, (...) up to return of spontaneous circulation or death, whichever came first
Capillary blood lactate (Lac)
Time frame: baseline (immediately after inclusion to the study, = minute 0), minute 4, 8, 12, 16, 20
Hospital mortality
Time frame: baseline (immediately after inclusion to the study)
Correlation of CRT, SMS and Lac and 30 days good neurological outcome
Time frame: baseline (immediately after inclusion to the study)
Correlation of CRT, SMS and Lac and hospital discharge good neurological outcome
Time frame: baseline (immediately after inclusion to the study)
Correlation of CRT/SMS and lactate
Time frame: baseline (immediately after inclusion to the study)
Correlation of SMS and CRT
Time frame: baseline (immediately after inclusion to the study)
Correlation of time since cardiac arrest and CRT/SMS/lactate
Time frame: baseline (immediately after inclusion to the study)
Correlation of catecholamine demand during the first 48 hours after ROSC and CRT/SMS
Time frame: from ROSC up to 48 hours after ROSC
Capillary refill time (CRT)
Time frame: minute 2, 4, 6, 8, (...) up to return of spontaneous circulation or death, whichever came first
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 Sep 2022.
- Derived from this study: PubMed 39838473Mueller M, Holzer M, Losert H, Grassmann D, Ettl F, Gatterbauer M, Magnet I, Nuernberger A, Kienbacher CL, Gelbenegger G, Girsa M, Herkner H, Krammel M. The association of capillary refill time and return of spontaneous circulation during out-of-hospital cardiac arrest: an observational study. Crit Care. 2025 Jan 21;29(1):37. doi: 10.1186/s13054-025-05255-4.
- 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.
Michael Holzer, MD principal investigator
Department of Emergency Medicine, Medical University of Vienna
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 Cardiac Arrest and Cardiac Arrest, Out-Of-Hospital, run by Medical University of Vienna at 1 site in Austria.
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: finished, as of the sponsor's last update on 26 Sep 2022. 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 Austria. 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?
Capillary refill time (CRT) (time frame: baseline (immediately after inclusion to the study)). 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 NCT04791995, which also lists 1 linked publication.
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 Sep 2022.