Study of Efficacy and Safety of the Plasmapheresis Method With Albumin Compensation Compared With the Plasmapheresis Method Without Albumin Compensation for Aging Biomarkers Correction in Men and Women Aged 40 to 55 Years Old

NCT04897113 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-05-21

No results posted yet for this study

Summary

Reaching active aging makes it important to implement new methods affecting the biological age of a person. Biochemical parameters of a blood test are aging biomarkers that are ones of the most accessible for testing. We know that, with age, there is increase in levels of LDL, triglycerides, homocysteine and other biomarkers relating the body state.

Methods of extracorporeal hemocorrection showed good results in this area. For instance, the use of plasmapheresis is very effective during prophylaxis, treatment and rehabilitation after various diseases/injuries. The main effects of plasmapheresis are related to removal of endo- and exotoxins, including products of lipid peroxidation, and to draining effect as a result of a heavy flow of interstitial fluid containing products of pathometabolism into the blood stream within concentration gradient (by "dynamic equilibrium" in concentration of different substances in intracellular, interstitial and intravascular compartments). These effects are also related to release of receptors, their sensitization to their own neurohumoral regulation mechanisms, to insulin, in particular (as consequences, lower glucose tolerance, lower substrate glycation).

Conditions

Interventions

PROCEDURE

plasma exchange with albumin

plasma exchange with albumin, two per week, 110% of the circulating plasma volume

PROCEDURE

plasma exchange without albumin

plasma exchange without albumin, two per week, 110% of the circulating plasma volume

Sponsors & Collaborators

  • The Orenburg Regional Clinical Hospital

    collaborator OTHER_GOV
  • DNKOM LLC

    collaborator OTHER
  • Pirogov Russian National Research Medical University

    collaborator OTHER
  • National Medical Research Center for Rehabilitation and Balneology

    lead OTHER

Principal Investigators

  • Ilmira Gilmutdinova · Federal State Budgetary Institution "National Medical Center for Rehabilitation and Balneology" of the Ministry of Health of Russia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-12
Primary Completion
2022-10-30
Completion
2022-12-30

Countries

  • Russia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04897113 on ClinicalTrials.gov