Application of Citrate Dialysate in Chronic Haemodialysis

Study investigating the safety and efficacy of the citrate dialysis solution compared to standard acetate dialysis solution. Use of citrate dialysis solution is not associated with a clinically relevant development of adverse events. It is hypothesized that citrate dialysate may provide a local anticoagulation effect in the dialyser improving removal of uremic toxins.

Study Overview

• Status: Completed
• Conditions: Chronic Renal Disease
• Intervention / Treatment: Device: Standard dialysate (StDi); Device: Citrate dialysate (CiDi)

Detailed Description

It is hypothesized that citrate dialysate may provide a local anticoagulation effect in the dialyser improving removal of uremic toxins. Study investigating the safety and efficacy of the citrate dialysis solution compared to standard acetate dialysis solution. Use of citrate dialysis solution is not associated with a clinically relevant development of adverse events.

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Lüdenscheid, Germany, 58509
    • Märkische Dialysezentren GmbH
  • Lüdenscheid, Germany, 58509
    • Nephrologische Gemeinschaftspraxis
  • Solingen, Germany, 42653
    • Städt. Klinikum Solingen gemeinnützige GmbH Klinik für Nephrologie und Allgemeine Innere Medizin
  • Wetzlar, Germany, 35578
    • PHV Dialysezentrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• signed informed consent
• patients of either sex aged ≥ 18 years
• stable chronic dialysis patients undergoing a 3x/week high-flux dialysis for at least three months
• patients without planned or predictable changes within diet, anticoagulation and medication regimen

Exclusion Criteria:

• pregnancy or lactation or woman in child bearing age without effective contraception
• planned surgeries or hospital stay within the next 9 weeks
• use of catheter as vascular access for dialysis
• severe comorbidities not allowing to follow the study protocol
• concomitant participation in another study
• previous participation in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: HD treated with standard dialysate	Device: Standard dialysate (StDi); Use during chronic dialysis 3x/week
ACTIVE_COMPARATOR: post-dilution oHDF with standard dialysate	Device: Standard dialysate (StDi); Use during chronic dialysis 3x/week
EXPERIMENTAL: pre-dilution oHDF with citrate dialysate	Device: Citrate dialysate (CiDi); Use during chronic dialysis 3x/week
EXPERIMENTAL: HD treated with citrate dialysate	Device: Citrate dialysate (CiDi); Use during chronic dialysis 3x/week
EXPERIMENTAL: post-dilution oHDF with citrate dialysate	Device: Citrate dialysate (CiDi); Use during chronic dialysis 3x/week
ACTIVE_COMPARATOR: pre-dilution oHDF with standard dialysate	Device: Standard dialysate (StDi); Use during chronic dialysis 3x/week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of clinically relevant calcium disturbances	during or post-dialysis hypocalcaemia with ionized Ca ≤ 0.9 mmol/l	patients are followed for 8 weeks
Occurrence of clinically relevant acid-base disturbances	during or post-dialysis severe alkalosis with pH ≥ 7.55	patients are followed for 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of clinically relevant acid-base disturbances	post-dialysis bicarbonate concentration ≥ 32 mmol/l	patients are followed for 8 weeks
Occurrence of clinically relevant acid-base disturbances	pre-treatment bicarbonate concentration ≥ 27 mmol/l	patients are followed for 8 weeks
Occurrence of clinically relevant intradialytic complications (adverse events)	related to citrate dialysate	patients are followed for 8 weeks
Occurrence of clinically relevant adverse events	related to citrate	patients are followed for 8 weeks

Collaborators and Investigators

• Sponsor: Fresenius Medical Care Deutschland GmbH
• Investigators: Principal Investigator: Michael Schmitz, Dr., Städt. Klinikum Solingen gemeinnützige GmbH Klinik für Nephrologie und Allgemeine Innere Medizin; Principal Investigator: Olaf Loke, Dr., Nephrologische Gemeinschaftspraxis; Principal Investigator: Klaus Kalb, Dr., Märkische Dialysezentren GmbH; Principal Investigator: Bernhard Fach, Dr., PHV Dialysezentrum

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): August 1, 2013

Study Registration Dates

• First Submitted: October 20, 2011
• First Submitted That Met QC Criteria: February 13, 2012
• First Posted (ESTIMATE): February 14, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): June 6, 2014
• Last Update Submitted That Met QC Criteria: June 5, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: dialysis; calcium; citrate dialysate
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Pharmaceutical Solutions; Dialysis Solutions
• Other Study ID Numbers: HD-CiDi-01-D; There is no secondary ID