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

National Medical Research Center for Rehabilitation and Balneology

Status

Unknown

Conditions

Hyper IgE Syndrome

Neuromuscular Diseases

Hyper Eosinophilic Syndrome

Hypercholesterolemia

Hyperbilirubinemia

Cardiovascular Diseases

Nervous System Diseases

Urologic Diseases

Gout

Diabetes

Hyper-LDL-cholesterolemia

Hyper Beta Lipoproteinemia

Treatments

Procedure: plasma exchange with albumin

Procedure: plasma exchange without albumin

Study type

Interventional

Funder types

Other

Identifiers

NCT04897113

RU-RB-01-01-21 of 08.02.2021

Details and patient eligibility

About

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).

Full description

One of the initial approaches of anti-ageing therapy is detoxification, reocorrection and immunocorrection. 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).

Thus, at this stage, experts assess effectiveness and organize data of existing prevention methods for premature aging and correction of aging biomarkers, as well as develop comprehensive programs for drug-free and pharmacological intervention. Introduction of the body detoxification method based on extracorporeal hemocorrection (developed in FGBU Russian Scientific Center for Medical Rehabilitation and Balneology of Ministry of Health of Russian Federation) may extend the range of effective and safe methods within such programs, as well as lower patients' biological age and, thus, lower risks of developing age-related diseases, decrease number of disability cases, which can contribute to life prolonging and improvement of its quality.

Enrollment

80 estimated patients

Sex

All

Ages

40 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Signed informed consent form.
Men and women aged 40-55.
Body mass index <30 kg / m2.
Level increase of one or several aging markers.
Understanding of requirements for study participants, written consent to participate in the study (including volunteer's consent for his/her health information related to the study to be used and passed on) and to perform procedures outlined in study protocol.
Negative pregnancy test for women of childbearing potential.

Non-inclusion Criteria:

Refusal to participate in the study.
Any health conditions that, according to investigators, might prevent volunteers from participating in the study.
Mental disorders, past medical history included.
10 + alcohol units per week (one alcohol unit equals 0,5 l of beer, 200 ml of wine or 50 ml of hard liquors) or any records of alcohol addiction.
Drug addiction, chemical abuse.
Pregnancy or breastfeeding.
Past medical history of severe allergic reactions.
General contraindications to plasmapheresis procedures.
Any other health conditions or reasons that, according to investigators, might increase risks for participants or reduce the likelihood of results needed to meet the study goals.

Exclusion criteria

Voluntary refusal to participate in the study.
Investigator doctor's decision on participant's exclusion for this participant's own benefit.
Participant refuses to cooperate with investigator or is undisciplined.
In case participant misses one or several study procedures or follow-up visits.
Development of severe adverse reactions or severe diseases/conditions unrelated to the study, requiring withdrawal from therapy.
Positive pregnancy test.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

plasmapheresis with albumin compensation

Experimental group

Description:

a course of hardware plasmapheresis procedures with replacement by colloidal (5% albumin solution) and crystalloid solutions (saline) in a ratio of 1: 3

Treatment:

Procedure: plasma exchange with albumin

plasmapheresis without albumin compensation

Experimental group

Description:

a course of hardware plasmapheresis procedures without replacement by albumin solution, only crystalloid solutions (saline).

Treatment:

Procedure: plasma exchange without albumin