Cardiac Arrest Clinical Trial
— ReCappOfficial title:
REsuscitation and CAPillary rePerfusion - A Cohort Study With Prospective Inclusion
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 |
Verified date | September 2022 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Austria | Vienna Municipal Emergency Service | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
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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