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Citrate based CVVH in Patients with Acute Renal Failure: Comparison of a New Citrate Based Hemofiltration Solution vs. Standard Bicarbonate Based Hemofiltration Solution.

Citrate based CVVH in Patients with Acute Renal Failure: Comparison of a New Citrate Based Hemofiltration Solution vs. Standard Bicarbonate Based Hemofiltration Solution.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
DRKS
Registry ID
DRKS00000224
Enrollment
120
Registered
2009-10-12
Start date
2004-11-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

N17

Interventions

Group 1: Continuous veno-venous hemofiltration with HF-Citrate 39-210T and regional citrate anticoagulation Group 2: Continuous veno-venous hemofiltration with MultiBic 2mmol/L Kalium and systemic hep

Sponsors

Fresenius Medical Care Deutschland GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Written informed consent given, Adult patients >18 years, Diagnosis of acute renal failure and indication for renal replacement therapy as assessed by volume overload, not correctable by diuretics in spite of adequate blood pressure and creatinine > 1.2 mg/dl, or increase of serum creatinine > 2.5 mg/dl or BUN > 50 mg/dl, or increase of serum potassium > 5.5 mmol/l due to oligo-anuria, Patients which at the time of inclusion have not yet started with the renal replacement therapy, Arterial line as vascular access, Mechanical ventilation

Exclusion criteria

Exclusion criteria: HIT II (heparin-induced thrombocytopenia type 2), Need to continue effective systemic heparin anticoagulation with an aPTT > 20% above the upper limit of the normal range , Metabolic alkalosis as defined by a pH > 7.50 and base excess of > +4 mmol/L, Pregnancy, lactation period, Patient on chronic renal replacement therapy, Participation in another study during the preceding 3 months, Previous participation in the same study

Design outcomes

Primary

MeasureTime frame
Acid-base status on day three after initiation of the CVVH treatment and on each consecutive day.

Secondary

MeasureTime frame
Therapeutic safety of the citrate based HF solution in comparison to bicarbonate HF solution with particular focus on adverse events like bleeding complications, heparin induced thrombocytopenia and mortality, acid-base derangements and systemic ionised calcium levels.

Countries

Germany

Contacts

Public ContactAdelheid Gauly

Fresenius Medical Care Deutschland GmbH

adelheid.gauly@fmc-ag.com06172 609 2260

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026