Clinical trial NCT01269112: Citrate-based Regional Anticoagulation Versus Heparin for Continuous Renal Replacement Therapy
Official title: Citrate-based Regional Anticoagulation Versus Heparin for Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Renal Failure: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Kidney Injury
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2011-01-04
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Mean daily dialysis delivered dose during intensive care stay
timeFrame: dialysis days during intensive care stay
Secondary outcomes:
measure: patient survival
timeFrame: 28-day and 90-day patient survivals
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospitals of Geneva
Study officials:
References:
citation: Tsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Dec 14;12(12):CD012467. doi: 10.1002/14651858.CD012467.pub3.
citation: Stucker F, Ponte B, Tataw J, Martin PY, Wozniak H, Pugin J, Saudan P. Efficacy and safety of citrate-based anticoagulation compared to heparin in patients with acute kidney injury requiring continuous renal replacement therapy: a randomized controlled trial. Crit Care. 2015 Mar 18;19(1):91. doi: 10.1186/s13054-015-0822-z.