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

Acute Kidney Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01269112
• Other study ID #: 09-069(NAC 09-27)
• Status: Completed
• Phase: Phase 4
• Start date: November 2010
• Est. completion date: November 2013

Study information

• Verified date: May 2016
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: November 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Device:
• citrate 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
• citrate 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

Locations

Country	Name	City	State
Switzerland	University Hospitals of Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean daily dialysis delivered dose during intensive care stay	Mean daily delivered dose during intensive care stay; Filter life span	dialysis days during intensive care stay
Secondary	patient survival		28-day and 90-day patient survivals