Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04139525
Other study ID # 0120-11/2019/3
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 15, 2020
Est. completion date December 2022

Study information

Verified date June 2022
Source University Medical Centre Ljubljana
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to compare the efficiency and biocompatibility of citrate and heparin anticoagulation during hemodialysis with medium cut-off polyarylethersulphone-polyvinylpirrolidone membrane (Theranova®).


Description:

The purpose of the study is to compare the efficiency and biocompatibility of citrate and heparin anticoagulation during hemodialysis (HD) with PES-PVP membrane. The research will be performed as a prospective clinical trial and will include 35 patients. Every patient will have 2 HD procedures with PES-PVP membrane in a randomized order: 1 with unfractionated heparin (UFH) and 1 with 8% trisodium citrate. We will compare the efficiency of both types of anticoagulation by measuring overall and instantaneous clearances of small, middle and protein-bound molecules (urea, creatinine, phosphate, β2-microglobulin, p-cresol). Biocompatibility will be evaluated by measuring activation of: complement (serum concentration of C3a and C5a), leukocytes (serum concentration of myeloperoxidase) and thrombocytes (serum concentration of PF4). We will also monitor complete blood count for occurrence of leukopenia and thrombocytopenia. After the HD electron microscopy of the membrane will be done in the proportion of included patients to evaluate adsorption of cells and formation of blood clots on the membrane.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 32
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patient on chronic hemodialysis - age 18 years old or more - being able to give an informed consent to participate in the survey Exclusion Criteria: - on therapeutic anticoagulation - citrate or heparin contraindicated - citrate or heparin intolerance - acute renal failure

Study Design


Intervention

Biological:
unfractionated heparin
A bolus of 30 I.U./kg at the start of hemodialysis, followed by 18 I.U./kg per every hour of hemodialysis.
8% trisodium citrate
8% trisodium citrate in the dose of 150 ml/h.

Locations

Country Name City State
Slovenia University Medical Centre Ljubljana Ljubljana

Sponsors (1)

Lead Sponsor Collaborator
Marija Malgaj Vrecko

Country where clinical trial is conducted

Slovenia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clearance of beta-2 microglobulin Overall and instantaneous clearance of beta-2 microglobulin. At the end of each hemodialysis procedure.
Primary Clearance of phosphate Overall and instantaneous clearance of phosphate. At the end of each hemodialysis procedure.
Primary Serum concentration of C3a, C5a, myeloperoxidase and PF-4 Blood for the laboratory measurements will be taken from the arterial line. At the start, after 15 minutes and at the end of each hemodialysis procedure.
Secondary Clearance of urea Overall and instantaneous clearance of urea. At the end of each hemodialysis procedure.
Secondary Clearance of creatinine Overall and instantaneous clearance of creatinine. At the end of each hemodialysis procedure.
Secondary Clearance of p-cresol Overall and instantaneous clearance of p-cresol. At the end of each hemodialysis procedure.
Secondary White blood cell count Blood for the laboratory measurements will be taken from the arterial line. At the start, after 15 minutes and at the end of each hemodialysis procedure.
Secondary Blood platelet count Blood for the laboratory measurements will be taken from the arterial line. At the start, after 15 minutes and at the end of each hemodialysis procedure.
See also
  Status Clinical Trial Phase
Completed NCT04076488 - Feasibility of an Interactive Tablet-based Exercise Program for People With Chronical Diseases N/A
Completed NCT03289650 - Extended Release Tacrolimus vs. Twice-Daily Tacrolimus Phase 3
Completed NCT04042324 - A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients Phase 1/Phase 2
Completed NCT01242904 - Use of a Bimodal Solution for Peritoneal Dialysis Phase 2
Active, not recruiting NCT03183245 - Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis Phase 3
Completed NCT03257410 - Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients N/A
Completed NCT03627299 - Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors Phase 4
Recruiting NCT05917795 - Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates N/A
Terminated NCT03539861 - Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients N/A
Withdrawn NCT02130817 - Belatacept in Kidney Transplantation of Moderately Sensitized Patients Phase 4
Completed NCT05540457 - Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis (BP Dialysis) N/A
Not yet recruiting NCT04900610 - The Effect of Vitamin K2 Supplementation on Arterial Stifness and Cardiovascular Events in PEritonial DIAlysis N/A
Recruiting NCT02176434 - Pilot Feasibility Study of Combined Kidney and Hematopoietic Stem Cell Transplantation to Cure End-stage Renal Disease N/A
Active, not recruiting NCT02581449 - Effect of Omega-3 Fatty Acids on Oxidative Stress and Dyslipidemia in Pediatric Patients Undergoing Hemodialysis Phase 2
Completed NCT02830490 - Reliability of Functional Measures in Hemodialysis Patient. N/A
Completed NCT02832440 - Comparison of Two Exercise Programmes in Patients Undergoing Hemodialysis N/A
Completed NCT02215655 - Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence N/A
Completed NCT02832466 - Quantifying the Deterioration of Physical Function in Renal Patients N/A
Completed NCT02134314 - C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI Phase 1/Phase 2
Recruiting NCT01912001 - Virtual Ward for Home Dialysis N/A