Predilution online hemodiafiltration with Citrasate - is it a possible option for heparin free procedure?

Citrate acid concentrate Citrasate for online predilution hemodiafiltration in patients on maintenance hemodialysis as an alternative of anticoagulation free procedure - comparison with acetate-based concentrate.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001117707

Enrollment

Registered

2013-10-04

Start date

2013-09-13

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We want to test the hypothesis, 4 hr online predilution HDF with Citrasate is possible to be realized without manifest clotting problems even with no anticoagulation therapy. As a secondary outcome we want to describe coagulation cascade activation based on TAT concentration during this HDF procedure.

Interventions

In a random order patients undergo one 4 hr procedure of online predilution hemodiafiltration with acetic acid or citrate acid (Citrasate) concentrate respectively. In two weeks and in a cross-over manner they undergo the second study procedure with citrate or acetic acid respectively. Citrate concentration in Citrasate is 0,8 mmol/l.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. chronic kidney disease 5/5 K/DOQI, more than 3 months on maintenance dialysis treatment, 2. native arteriovenous fistula with blood flow at least 300 ml/min.

Exclusion criteria

1. laboratory markers of hepatopathy ( = ALT and AST more than double of upper borderline lab value), 2. hemostasis disorder ( = pathological value of prothrombin time and aPTT and thrombocyte count less than 100 000/ul), 3. antithrombotic treatment excluding acetylsalicylic acid (aspirin) 4. malignancy

Outcome results