Application of Citrate Dialysate in Chronic Haemodialysis

Chronic Renal Disease Clinical Trial

Official title:

Application of Citrate Dialysate in Chronic Haemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01532297
• Other study ID #: HD-CiDi-01-D
• Secondary ID: There is no seco
• Status: Completed
• Phase: N/A
• First received: October 20, 2011
• Last updated: June 5, 2014
• Start date: October 2011
• Est. completion date: August 2013

Study information

• Verified date: June 2014
• Source: Fresenius Medical Care Deutschland GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: August 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Renal Disease
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Device:
• Citrate dialysate (CiDi)
Use during chronic dialysis 3x/week
• Standard dialysate (StDi)
Use during chronic dialysis 3x/week

Locations

Country	Name	City	State
Germany	Märkische Dialysezentren GmbH	Lüdenscheid
Germany	Nephrologische Gemeinschaftspraxis	Lüdenscheid
Germany	Städt. Klinikum Solingen gemeinnützige GmbH Klinik für Nephrologie und Allgemeine Innere Medizin	Solingen
Germany	PHV Dialysezentrum	Wetzlar

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Medical Care Deutschland GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of clinically relevant calcium disturbances	during or post-dialysis hypocalcaemia with ionized Ca = 0.9 mmol/l	patients are followed for 8 weeks	Yes
Primary	Occurrence of clinically relevant acid-base disturbances	during or post-dialysis severe alkalosis with pH = 7.55	patients are followed for 8 weeks	Yes
Secondary	Occurrence of clinically relevant acid-base disturbances	post-dialysis bicarbonate concentration = 32 mmol/l	patients are followed for 8 weeks	Yes
Secondary	Occurrence of clinically relevant acid-base disturbances	pre-treatment bicarbonate concentration = 27 mmol/l	patients are followed for 8 weeks	Yes
Secondary	Occurrence of clinically relevant intradialytic complications (adverse events)	related to citrate dialysate	patients are followed for 8 weeks	Yes
Secondary	Occurrence of clinically relevant adverse events	related to citrate	patients are followed for 8 weeks	Yes