NCT04791995

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

March 3, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

September 26, 2022

Status Verified

September 1, 2022

Enrollment Period

1.1 years

First QC Date

March 2, 2021

Last Update Submit

September 22, 2022

Conditions

Keywords

capillary refill timeskin mottling scorecapillary lactatemicroperfusioncardiopulmonary resuscitation

Outcome Measures

Primary Outcomes (1)

  • Capillary refill time (CRT)

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

    baseline (immediately after inclusion to the study)

Secondary Outcomes (10)

  • 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

  • Capillary blood lactate (Lac)

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

  • Hospital mortality

    baseline (immediately after inclusion to the study)

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

    baseline (immediately after inclusion to the study)

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

    baseline (immediately after inclusion to the study)

  • +5 more secondary outcomes

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult out-of-hospital cardiac arrest patients

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vienna Municipal Emergency Service

Vienna, Austria

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Heart ArrestOut-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Michael Holzer, MD

    Department of Emergency Medicine, Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Michael Holzer

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 10, 2021

Study Start

March 3, 2021

Primary Completion

March 31, 2022

Study Completion

May 1, 2022

Last Updated

September 26, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations