Clinical trial NCT04791995: Resuscitation and Capillary Reperfusion
Official title: REsuscitation and CAPillary rePerfusion - A Cohort Study With Prospective Inclusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult out-of-hospital cardiac arrest patients

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* All patients ≥18 years during cardiopulmonary resuscitation
* witnessed cardiac arrest

Exclusion Criteria:

* 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

Primary outcomes:
measure: Capillary refill time (CRT)
timeFrame: baseline (immediately after inclusion to the study)
Secondary outcomes:
measure: Skin mottling score (SMS)
timeFrame: 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
measure: Capillary blood lactate (Lac)
timeFrame: baseline (immediately after inclusion to the study, = minute 0), minute 4, 8, 12, 16, 20
measure: Hospital mortality
timeFrame: baseline (immediately after inclusion to the study)
measure: Correlation of CRT, SMS and Lac and 30 days good neurological outcome
timeFrame: baseline (immediately after inclusion to the study)
measure: Correlation of CRT, SMS and Lac and hospital discharge good neurological outcome
timeFrame: baseline (immediately after inclusion to the study)
measure: Correlation of CRT/SMS and lactate
timeFrame: baseline (immediately after inclusion to the study)
measure: Correlation of SMS and CRT
timeFrame: baseline (immediately after inclusion to the study)
measure: Correlation of time since cardiac arrest and CRT/SMS/lactate
timeFrame: baseline (immediately after inclusion to the study)
measure: Correlation of catecholamine demand during the first 48 hours after ROSC and CRT/SMS
timeFrame: from ROSC up to 48 hours after ROSC
measure: Capillary refill time (CRT)
timeFrame: minute 2, 4, 6, 8, (...) up to return of spontaneous circulation or death, whichever came first
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Municipal Emergency Service
Study officials:
affiliation: Department of Emergency Medicine, Medical University of Vienna
name: Michael Holzer, MD
role: PRINCIPAL_INVESTIGATOR
References: