ReCapp: Resuscitation and Capillary Reperfusion

Sponsor
Medical University of Vienna (Other)
Overall Status
Recruiting
CT.gov ID
NCT04791995
Collaborator
(none)
50
1
9
5.6

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
REsuscitation and CAPillary rePerfusion - A Cohort Study With Prospective Inclusion
Actual Study Start Date :
Mar 3, 2021
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Outcome Measures

Primary Outcome Measures

  1. Capillary refill time (CRT) [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 Outcome Measures

  1. Skin mottling score (SMS) [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) [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 [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 [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 [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 [baseline (immediately after inclusion to the study)]

    Correlation of CRT/SMS and lactate

  7. Correlation of SMS and CRT [baseline (immediately after inclusion to the study)]

    Correlation of SMS and CRT

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 95 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vienna Municipal Emergency Service Vienna Austria

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

  • Principal Investigator: Michael Holzer, MD, Department of Emergency Medicine, Medical University of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michael Holzer, Prof. Michael Holzer, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT04791995
Other Study ID Numbers:
  • 001
First Posted:
Mar 10, 2021
Last Update Posted:
Mar 10, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Michael Holzer, Prof. Michael Holzer, Medical University of Vienna
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2021