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Completed

NCT Number: NCT01532297

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.

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Key information

Conditions

Chronic Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Märkische Dialysezentren GmbH, Lüdenscheid, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Citrate dialysate (CiDi)

Device

Use during chronic dialysis 3x/week

Standard dialysate (StDi)

Device

Use during chronic dialysis 3x/week

Primary outcomes

  1. Occurrence of clinically relevant calcium disturbances

    Time frame: patients are followed for 8 weeks

    during or post-dialysis hypocalcaemia with ionized Ca ≤ 0.9 mmol/l

  2. Occurrence of clinically relevant acid-base disturbances

    Time frame: patients are followed for 8 weeks

    during or post-dialysis severe alkalosis with pH ≥ 7.55

Secondary outcomes

  1. Occurrence of clinically relevant acid-base disturbances

    Time frame: patients are followed for 8 weeks

    post-dialysis bicarbonate concentration ≥ 32 mmol/l

  2. Occurrence of clinically relevant acid-base disturbances

    Time frame: patients are followed for 8 weeks

    pre-treatment bicarbonate concentration ≥ 27 mmol/l

  3. Occurrence of clinically relevant intradialytic complications (adverse events)

    Time frame: patients are followed for 8 weeks

    related to citrate dialysate

  4. Occurrence of clinically relevant adverse events

    Time frame: patients are followed for 8 weeks

    related to citrate

Sponsors and collaborators

Lead sponsor

Fresenius Medical Care Deutschland GmbH

Industry

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 14, 2012
Registry last updated
Jun 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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