Resuscitation and Capillary Reperfusion

Cardiac Arrest Clinical Trial

— ReCapp  

Official title:

REsuscitation and CAPillary rePerfusion - A Cohort Study With Prospective Inclusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04791995
• Other study ID #: 001
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

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

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