Impact of Nimodipine on Sublingual Microcirculation in Patients With Hemorrhage - a Prospective Monocentric Observational Study

Recruiting

• Conditions: Subarachnoid Hemorrhage

• Registration Number: NCT04311840
• Lead Sponsor: University Hospital Hradec Kralove

Brief Summary

Nimodipine can increase Functional Capillary Density (FCD) as a parameter of the sublingual microcirculation in patients with subarachnoid hemorrhage (SAH) compared to patients without nimodipine.

Detailed Description

SAH group - in patients with SAH and documented vasospasms by digital subtraction angiography (DSA) of trans-cranial doppler imaging (TCD) of arteria cerebri media nimodipine is indicated because it is proven to improve the clinical outcome. The disfunction of cerebral microcirculation in rats with SAH has been documented \[1-6\]. Changes in sublingual microcirculation in patients with SAH with documented vasospasms with nimodipine has not been described.

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2019-11-18
• Study First Submitted QC: 2020-03-15
• Study First Posted: 2020-03-17
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-25
• Last Update Posted: 2022-09-27
• Primary Completion: 2022-10-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• adulthood
• ICU admission
• diagnosis of non-traumatic subarachnoid hemorrhage

Exclusion Criteria

• inherited coagulation disorder
• rheumatic disease
• microangiopathy
• patient of representative refusal

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional capillary density (FCD)	One week	Parameter describing the perfusion of the microcirculation
Proportion of perfused vessels (PPV)	One week	Parameter describing the perfusion of the microcirculation

Secondary Outcome Measures

Name	Time	Method
Vasospasm occurence	One week	Occurence of vasospasms on angiography and/or transcranial Doppler
Circulatory incoherence	One week	Deranged microcirculation in patients on catecholamines

Trial Locations

Locations (1)

University Hospital Hradec Kralove; 🇨🇿 Hradec Králové, Třebeš, Czechia