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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04791995
Other study ID # 001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 3, 2021
Est. completion date May 1, 2022

Study information

Verified date September 2022
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date May 1, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 95 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Austria Vienna Municipal Emergency Service Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 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
Secondary 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 baseline (immediately after inclusion to the study, = minute 0), minute 4, 8, 12, 16, 20
Secondary Hospital mortality Correlation of CRT, SMS and Lac with hospital mortality baseline (immediately after inclusion to the study)
Secondary 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) baseline (immediately after inclusion to the study)
Secondary 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) baseline (immediately after inclusion to the study)
Secondary Correlation of CRT/SMS and lactate Correlation of CRT/SMS and lactate baseline (immediately after inclusion to the study)
Secondary Correlation of SMS and CRT Correlation of SMS and CRT baseline (immediately after inclusion to the study)
Secondary Correlation of time since cardiac arrest and CRT/SMS/lactate Correlation of time since cardiac arrest and CRT/SMS/lactate baseline (immediately after inclusion to the study)
Secondary 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 from ROSC up to 48 hours after ROSC
Secondary Capillary refill time (CRT) Capillary refill time in seconds measured on one finger and one earlobe for ROSC vs. no ROSC minute 2, 4, 6, 8, (...) up to return of spontaneous circulation or death, whichever came first
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