Release of Epoxyeicosatrienoic Acids From Erythrocytes During the Use of Extracorporeal Procedures (Heart-lung Machine)

NCT04598360 | Completed

• 1 other identifier: EA2/113/08
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Hypotension with potentially serious consequences for organ perfusion is a common complication in extracorporeal procedures such as heart-lung-machine. The exact reasons for this are still insufficiently clarified. Probably periinterventional vasorelaxant released substances play a crucial role in these procedures. These substances could be due to contact of blood cells with the Membrane in the HLM arise. In this project the hypothesis will be checked, if EETs / DHETs are released by Erythrocytes during this extracorporeal procedure and thus act as potential candidate products for the result of hypotonic phases during usage of heart-lung-machine. We will determine differences in RBC fatty acids profiling in patients before and after heart-lung-machine intervention. RBC fatty acids profiling will be achieved by using targeted HPLC-MS mass spectrometry. It is believed that during HLM there is an increase in EETs / DHETs in the serum and in the erythrocytes. It is believed that shear forces play an important role in the release of erythrocyte EETs / DHETs.

Conditions

Coronary Arteriosclerosis; Valve Heart Disease

Keywords

Fatty Acid Metabolism; Erythrocytes; Lipidomics; Heart-Lung-Machine

Outcome Measures

Primary Outcomes (1)

• Coefficient of variation of relative quantities of erythrocyte fatty-acid parameters related to its dynamic during HLM, using LC-MS / MS.

  EETs / DHETs will be analyzed in the erythrocytes and serum of the recovered blood samples. The determination will made in cooperation with a Berliner Biotech company. This involves liquid chromatography with MS coupling (LC-MS / MS) used. The data analysis is carried out by means of suitable statistical methods to perform erythrocyte fatty-acid status profiling.

  4-5months

Study Arms (1)

Experimental: Erythrocyte Fatty-Acid Status

EXPERIMENTAL

Erythrocyte Fatty-Acid Status Profiling of cardiac surgery patients are studied before and during heart-lung-machine procedure using LC-MS / MS

Procedure: Heart-Lung-Machine

Interventions

Heart-Lung-Machine PROCEDURE

blood sample before and during a single Heart-Lung-Machine procedure

Experimental: Erythrocyte Fatty-Acid Status

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are undergoing an operation with the aid of the heart-lung machine for cardiac surgery
• Age over 18 years
• Ability to consent
• There is a written consent of the study participant

You may not qualify if:

• none

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité University Experimental & Clinical Research Center

Berlin, 13125, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease; Heart Valve Diseases

Interventions

Heart-Lung Machine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Artificial Organs; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Benjamin Gollasch

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: October 22, 2020
• Study Start: November 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: January 1, 2022
• Last Updated: March 22, 2022

Record last verified: 2022-03

Locations

DE (1)