The Effect of Vitamin E-coated Polysulfone Membrane on Oxidative Stress, Inflammation and Monocytes in Critically Ill Patients in CRRT

NCT03489759 | Unknown

• 1 other identifier: 79/16A
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study evaluate the effect of a membrane in polysulfone covered with vitamin E (ViE15-A, ASAHI Kasey, Tokyo, Japan) versus non-vitamin E polysulfone membrane (REXEED-15A, ASAHI Kasey, Tokyo, Japan) in critically ill patients admitted to intensive care undergoing continuous extracorporeal dialysis (CRRT). The current randomized study is designed to assess the effect on the levels of oxidative stress, pro and anti-inflammatory cytokines and the mode and amount of death of monocytic cell lines using ViE 15-A in comparison withe REXEED-15A. The investigators hypothezise that the ViE15-A versus REXEED-15A will have different effect on the levels of oxidative stress, pro and anti-inflammatory cytokines and the mode and amount of death of monocytic cell lines.

Conditions

Renal Failure; Renal Insufficiency, Acute

Keywords

Acute Kidney Injury; Oxidative Stress; Renal Replacement Therapy; Vitamine E-coated Polysulfone Membrane

Outcome Measures

Primary Outcomes (10)

• Copper/Zinc

  In vivo comparison of ROS concentrations in two groups

  change from 24 to 72 hours

• Superoxide Dismutas

  In vivo comparison of ROS concentrations in two groups

  change from 24 to 72 hours

• Endogenous peroxidase activity

  In vivo comparison of ROS concentrations in two groups

  change from 24 to 72 hours

• Nitric Oxide

  In vivo comparison of ROS concentrations in two groups

  change from 24 to 72 hours

• Viability

  Ex vivo comparison of relative decrease of monocytes cell line incubated in plasma

  change from 24 to 72 hours

• Apoptosis

  Ex vivo comparison of relative decrease of monocytes cell line incubated in plasma

  change from 24 to 72 hours

• Necrosis

  Ex vivo comparison of relative decrease of monocytes cell line incubated in plasma

  change from 24 to 72 hours

• Interleukine-6

  In vivo comparison of relative reductions of inflammatory cytokines concentrations in two groups

  change from 24 to 72 hours

• Interleukine -10

  In vivo comparison of relative reductions of inflammatory cytokines concentrations in two groups

  change from 24 to 72 hours

• Interleukine-18

  In vivo comparison of relative reductions of inflammatory cytokines concentrations in two groups

  change from 24 to 72 hours

Secondary Outcomes (8)

• Comparison of CRRT-free days from enrollment to ICU discharge in two groups

  7 days

• Comparison of mechanical Ventilation-free days from enrollment to ICU discharge in two groups

  7 days

• Comparison of vasopressor drugs-free days in two groups

  7 days

• Comparison of ICU length of stay in two groups

  7 days

• Comparison of renal recovery in two groups

  7 days

Study Arms (2)

ViE15-A

EXPERIMENTAL

The patients were randomly allocated to two groups by using computer-generated numbers. The renal replacement therapy will be started using ViE15-A hemofilter

Device: ViE15-A

REXEED-15A

ACTIVE COMPARATOR

TThe patients were randomly allocated to two groups by using computer-generated numbers. The renal replacement therapy will be started using REXEED-15A

Device: REXEED-15A

Interventions

ViE15-A DEVICE

The type of dialytic treatment that will be used during the study will be continuous venous hemofiltration (CVVH-Continuous veno-venous hemofiltration). The filter will be ViE15-A.

ViE15-A

REXEED-15A DEVICE

The type of dialytic treatment that will be used during the study will be continuous venous hemofiltration (CVVH-Continuous veno-venous hemofiltration). The filter will be REXEED-15A.

REXEED-15A

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years
• Acute Kidney Injury
• ICU patients with clinical indication for Continuous Renal Replacement Therapy
• Clinical decision to begin CVVH for at least 24 hours with high flux filter (defined as membranes with an ultrafiltration coefficient KUF \> 25ml/Kg/h)
• Obtain the informed consent

You may not qualify if:

• Hemodialysis patients, peritoneal dialysis patients and transplant recipient;
• Hypothermia (T \< 36°C)
• Regional Anticoagulation with Citrate
• Septic Shock;
• Neoplasm in Chemotherapy
• Extra-Corporeal Membrane Oxygenation
• Cardio Circulatory Arrest
• Autoimmune disease or immunosuppressed patients;
• Life expectancy \< 24 hr
• Pregnancy;
• Informed Consent refused by the patient or surrogate decision-maker

Sponsors & Collaborators

• St. Bortolo Hospital: lead

Study Sites (1)

San Bortolo Hospital

Vicenza, 36100, Italy

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Claudio Ronco, MD

  Department of Nephrology, Dialysis and Transplantation

  STUDY DIRECTOR

Central Study Contacts

Silvia De Rosa, MD

CONTACT

+393933098583; derosa.silvia@ymail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization list will be kept in a special lockable closet, not accessible to the other investigators involved in the study. The one who will create the list will not be involved in any other role in the present study. The filter label, and hence the name, will be covered by a white covering label. Each kit of filters needed to perform a single treatment will be prepared in a closed box and the patient number will be written on it, so that the user who performs the treatment will not be able to understand which filter it is. All the other investigators involved in the present study (nurses in the Nephrology department who will follow the treatment, the researchers who will collect the clinical data, the biologists who will analyze the samples and the statisticians who will analyze the data) will not know which filter has been applied in each treatment.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: April 5, 2018
• Study Start: March 13, 2018
• Primary Completion: September 13, 2018
• Study Completion: December 13, 2019
• Last Updated: April 4, 2019

Record last verified: 2019-04

Locations

IT (1)