Application of Citrate Dialysate in Chronic Haemodialysis

NCT ID: NCT01532297

Last Updated: 2014-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Renal Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HD treated with standard dialysate

Group Type ACTIVE_COMPARATOR

Standard dialysate (StDi)

Intervention Type DEVICE

Use during chronic dialysis 3x/week

post-dilution oHDF with standard dialysate

Group Type ACTIVE_COMPARATOR

Standard dialysate (StDi)

Intervention Type DEVICE

Use during chronic dialysis 3x/week

pre-dilution oHDF with citrate dialysate

Group Type EXPERIMENTAL

Citrate dialysate (CiDi)

Intervention Type DEVICE

Use during chronic dialysis 3x/week

HD treated with citrate dialysate

Group Type EXPERIMENTAL

Citrate dialysate (CiDi)

Intervention Type DEVICE

Use during chronic dialysis 3x/week

post-dilution oHDF with citrate dialysate

Group Type EXPERIMENTAL

Citrate dialysate (CiDi)

Intervention Type DEVICE

Use during chronic dialysis 3x/week

pre-dilution oHDF with standard dialysate

Group Type ACTIVE_COMPARATOR

Standard dialysate (StDi)

Intervention Type DEVICE

Use during chronic dialysis 3x/week

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Citrate dialysate (CiDi)

Use during chronic dialysis 3x/week

Intervention Type DEVICE

Standard dialysate (StDi)

Use during chronic dialysis 3x/week

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fresenius Medical Care Deutschland GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael Schmitz, Dr.

Role: PRINCIPAL_INVESTIGATOR

Städt. Klinikum Solingen gemeinnützige GmbH Klinik für Nephrologie und Allgemeine Innere Medizin

Olaf Loke, Dr.

Role: PRINCIPAL_INVESTIGATOR

Nephrologische Gemeinschaftspraxis

Klaus Kalb, Dr.

Role: PRINCIPAL_INVESTIGATOR

Märkische Dialysezentren GmbH

Bernhard Fach, Dr.

Role: PRINCIPAL_INVESTIGATOR

PHV Dialysezentrum

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Märkische Dialysezentren GmbH

Lüdenscheid, , Germany

Site Status

Nephrologische Gemeinschaftspraxis

Lüdenscheid, , Germany

Site Status

Städt. Klinikum Solingen gemeinnützige GmbH Klinik für Nephrologie und Allgemeine Innere Medizin

Solingen, , Germany

Site Status

PHV Dialysezentrum

Wetzlar, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2.

Reference Type DERIVED
PMID: 37651553 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

There is no secondary ID

Identifier Type: -

Identifier Source: secondary_id

HD-CiDi-01-D

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.