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Citrate-based Regional Anticoagulation Versus Heparin for Continuous Renal Replacement Therapy

Citrate-based Regional Anticoagulation Versus Heparin for Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Renal Failure: a Randomized Controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01269112
Enrollment
103
Registered
2011-01-04
Start date
2010-11-30
Completion date
2013-11-30
Last updated
2019-08-14

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

Conditions

Acute Kidney Injury

Brief summary

Critically ill patients with acute kidney injury (AKI) are at high risk of bleeding on account of coagulopathy, platelet dysfunction, frequent liver dysfunction and invasive procedures.In patients at high risk of bleeding, anticoagulation restricted to the circuit (regional anticoagulation) has been advocated as the method of choice.However, citrate anticoagulation may have many metabolic consequences, such as metabolic alkalosis due to citrate metabolism into bicarbonate, and in patients with liver disease, metabolic acidosis and hypocalcemia may occur.Implementation of citrate-based regional anticoagulation with frequent monitoring of acid-base and electolytes is also more challenging for the nurses and does not eliminate the need of a low-dose systemic anticoagulation for thromboses prophylaxis in most of the patients. Citrate-based regional anticoagulation is therefore mainly advocated only for patients at high-risk of bleeding. The investigators plan to implement an open-label randomized control trial assessing the effectiveness of citrate-based regional anticoagulation in critically ill patients with AKI and with a special emphasis on the safety profile of this treatment in patients with severe liver failure.

Detailed description

monocentric prospective open-label randomized controlled trial at the ICU of the University Hospitals of Geneva (Switzerland). ICU patients eligible if they 18 yr old and had an AKI requiring CRRT Exclusion criteria Patients excluded if they had active hemorrhagic disorders or severe thrombocytopenia (\< 50x109/L), a history of heparin-induced thrombocytopenia, severe liver failure defined as a factor V \<20% or were on the waiting list for liver transplantation. Treatment assignment Subjects enrolled into the trial randomly allocated to either heparin or citrate anticoagulation

Interventions

DEVICEcitrate regional anticoagulation

Patients randomly allocated to 2 treatment groups: Treatment A: - Regional citrate-based anticoagulation with the Prismocitrate® 10/2 solution (GAMBRO) Treatment B: - Standard unfractionated heparin anticoagulation

Sponsors

University Hospital, Geneva
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with acute kidney injury requiring renal replacement therapy (RIFLE criteria) * Patients (males or females) \> 18 yrs old * Consent form signed (or in emergency investigator's statement form)

Exclusion criteria

* Patients with active bleeding disorders * Patients with past history of heparin-induced thrombocytopenia (HIT) * Patients with very severe liver disease ( patients awaiting liver transplant or factor V \< 20% or MELD score \> 25) * Pregnancy (negative pregnancy test required in child-bearing age women prior to inclusion) * Enrollment in another concurrent therapeutic trial

Design outcomes

Primary

MeasureTime frameDescription
Mean daily dialysis delivered dose during intensive care staydialysis days during intensive care stay* Mean daily delivered dose during intensive care stay * Filter life span

Secondary

MeasureTime frame
patient survival28-day and 90-day patient survivals

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026