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

NCT ID: NCT01269112

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-11-30

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

Conditions

Acute Kidney Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

heparin

CVVHDF performed using unfractionated heparin as anticoagulant and Prismasol as reinjection and dialysate fluids

Group Type: PLACEBO_COMPARATOR

citrate regional anticoagulation

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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

CVVHDF performed using Prismocitrate 18/0 solution (Trisodium citrate 18 mmol/L

Group Type: ACTIVE_COMPARATOR

citrate regional anticoagulation

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Patrick Saudan

PD Dr Patrick Saudan, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospitals of Geneva

Geneva, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 33314078 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25881975 (View on PubMed)

Other Identifiers

09-069(NAC 09-27)

Identifier Type: -

Identifier Source: org_study_id