NCT03857984

Brief Summary

Hypotension with potentially serious consequences for organ perfusion is a common complication in extracorporeal procedures such as hemodialysis / hemofiltration. 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 dialyzer / hemofilter arise. In this project the hypothesis will be checked, if EETs / DHETs are released by Erythrocytes during hemodialysis and thus act as potential candidate products for the result of hypotonic phases in the Dialysis. We will determine differences in RBC fatty acids profiling in hemodialysis patients before and after dialysis intervention. Furthermore a matched control group of healthy individuals will be profiled. RBC fatty acids profiling will be achieved by using targeted HPLC-MS mass spectrometry. It is believed that during hemodialysis / HLM / CVVH 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 28, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

3.7 years

First QC Date

February 24, 2019

Last Update Submit

March 8, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Coefficient of variation of relative quantities of erythrocyte fatty-acid parameters related to its dynamic during Hemodialysis, 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.

    4-5 Months

Study Arms (1)

Erythrocyte Fatty-Acid Status

EXPERIMENTAL

Erythrocyte Fatty-Acid Status Profiling of HD patients are studied before and after a single HD using LC-MS / MS

Other: Blood sampling

Interventions

blood sample before and after a single HD

Erythrocyte Fatty-Acid Status

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have a history of renal failure and undergo hemodialysis / hemofiltration
  • Age over 18 years
  • Ability to consent
  • There is a written consent of the study participant

You may not qualify if:

  • chronic illness requiring any medication
  • pregnancy
  • limitations regarding functioning in the hypoxic chamber
  • inability to follow simple instructions relevant or severe abnormalities in medical history, physical examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité University Experimental & Clinical Research Center

Berlin, 13125, Germany

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 24, 2019

First Posted

February 28, 2019

Study Start

May 1, 2018

Primary Completion

January 1, 2022

Study Completion

February 1, 2022

Last Updated

March 10, 2022

Record last verified: 2022-03

Locations