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Completed

NCT Number: NCT04791995

Resuscitation and Capillary Reperfusion

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.

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Key information

Conditions

Cardiac Arrest Cardiac Arrest, Out-Of-Hospital Cardiopulmonary Arrest Cardiopulmonary Arrest With Successful Resuscitation Cardiovascular Diseases Heart Arrest Heart Diseases Out-of-Hospital Cardiac Arrest

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vienna Municipal Emergency Service

Vienna, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    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

  2. Capillary blood lactate (Lac)

    Time frame: baseline (immediately after inclusion to the study, = minute 0), minute 4, 8, 12, 16, 20

    Capillary lactate in mmol/L from the capillary bed of a finger for ROSC vs noROSC and for correlations with CRT, SMS

  3. Hospital mortality

    Time frame: baseline (immediately after inclusion to the study)

    Correlation of CRT, SMS and Lac with hospital mortality

  4. Correlation of CRT, SMS and Lac and 30 days good neurological outcome

    Time frame: baseline (immediately after inclusion to the study)

    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)

  5. Correlation of CRT, SMS and Lac and hospital discharge good neurological outcome

    Time frame: baseline (immediately after inclusion to the study)

    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)

  6. Correlation of CRT/SMS and lactate

    Time frame: baseline (immediately after inclusion to the study)

    Correlation of CRT/SMS and lactate

  7. Correlation of SMS and CRT

    Time frame: baseline (immediately after inclusion to the study)

    Correlation of SMS and CRT

  8. Correlation of time since cardiac arrest and CRT/SMS/lactate

    Time frame: baseline (immediately after inclusion to the study)

    Correlation of time since cardiac arrest and CRT/SMS/lactate

  9. Correlation of catecholamine demand during the first 48 hours after ROSC and CRT/SMS

    Time frame: from ROSC up to 48 hours after ROSC

    Cumulative catecholamine demand during the first 48 hours after ROSC in correlation with CRT/SMS/Lac during resuscitation

  10. Capillary refill time (CRT)

    Time frame: minute 2, 4, 6, 8, (...) up to return of spontaneous circulation or death, whichever came first

    Capillary refill time in seconds measured on one finger and one earlobe for ROSC vs. no ROSC

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

REsuscitation and CAPillary rePerfusion - A Cohort Study With Prospective Inclusion

Acronym: ReCapp

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 10, 2021
Registry last updated
Sep 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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