Influence of RIC on the Orthostatic Competence of the Microcirculation

NCT05990907 | Unknown

• 1 other identifier: RIC-KIP
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial (pilot study) is to learn about the microcirculatory regulation of the lower extremity under orthostatic stress with and without RIC - Remote Ischemic Preconditioning in healthy participants. The main question it aims to answer are: Do the beneficial effects of RIC withstand orthostatic stress? / Does RIC benefit lower extremity microcirculation in ortho-statically stressed subjects? Is there a relationship/correlation between the variables of microcirculation and hemodynamics in the context of RIC and orthostatic loading?

Conditions

Microcirculation; Orthostatic Intolerance; Remote Ischemic Preconditioning; Hemodynamics

Keywords

Microcirculation; Remote ischemic preconditioning

Outcome Measures

Primary Outcomes (1)

• Microcirculation parameters

  Microcirculation parameter (Measured with O2C laser Doppler and tissue spectrometry LEA Medizintechnik GmbH, Giessen, Germany) Relative blood flow in arbitrary units \[AU\]

  continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment

Secondary Outcomes (6)

• Microcirculation parameters - oxygen saturation

  continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment

• Microcirculation parameters - Relative amount of hemoglobin

  continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment

• Hemodynamics

  continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment

• Hemodynamics

  continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment

• Hemodynamics

  continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment

Study Arms (1)

Tilting table without and with RIC

OTHER

The experimental setup consists of two separate measurements. In the first measurement, the subject is ortho-statically stressed by changing the position (lying to upright) on a tilting table (similar to the established tilting table test). 24 hours after the first measurement, the ischemic preconditioning will be carried out in three cycles with a directly subsequent tilting table test.

Procedure: Remote ischemic preconditioning

Interventions

Remote ischemic preconditioning PROCEDURE

The empty tourniquet (VBM Tourniquet Touch®, Sulz a.N. Germany) is attached to the right upper arm. The measurement starts from this point in time. After lying flat for 10 minutes, the upper arm tourniquet is inflated to 250 mmHg. In all subjects, the ischemia was verified by palpation and Doppler signal of the radial artery. The ischemia phase is carried out for 10 minutes, so the tourniquet is opened and a 10-minute reperfusion phase is started, followed by a total of 3 cycles. After the 3rd ischemia phase, the tilting table test is followed by a 15-minute lying interval.

Tilting table without and with RIC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-smokers
• No diseases relevant to circulation and blood flow (arterial hypertension, peripheral arterial occlusive disease, chronic venous insufficiency)
• Subjects must be capable of insight. Anyone who can understand the nature, significance, and scope of the clinical trial and determine their will accordingly is capable of insight.

You may not qualify if:

• Non-consent
• Lack of compliance
• Syncope tendency

Sponsors & Collaborators

• ISAR Klinikum: lead

Study Sites (1)

ISAR Klinikum

Munich, Bavaria, 80331, Germany

Location

MeSH Terms

Conditions

Orthostatic Intolerance

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ulf Dornseifer, MD, PhD

  Department Plastic Surgery ISAR Klinikum, Munich

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Due to the study design, randomization and blinding are not possible.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief resident

Model Details: The research project is a controlled, single-arm, monocentric clinical study. Due to the study design, randomization and blinding are not possible. Unfortunately, there is no scientific data on how long the effects of ischemic preconditioning last. Thus, in a cross-over design study with protocols 1 and 2 in a different order, there would be a risk or bias that subjects who received ischemic preconditioning in the first measurement would have this effect in the second measurement. For this reason, we decided on a standardized procedure for measurement 1 (without ischemic preconditioning) and measurement 2 (with ischemic preconditioning). In this case, the study design would be one-armed.

Study Record Dates

• First Submitted: July 30, 2023
• First Posted: August 14, 2023
• Study Start: July 30, 2023
• Primary Completion: August 10, 2023
• Study Completion: August 13, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)