Skip to main content
OpenTrials
Completed

NCT Number: NCT01269112

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospitals of Geneva

Geneva, 1211, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

citrate regional anticoagulation

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

Primary outcomes

  1. Mean daily dialysis delivered dose during intensive care stay

    Time frame: dialysis days during intensive care stay

    • Mean daily delivered dose during intensive care stay
    • Filter life span

Secondary outcomes

  1. patient survival

    Time frame: 28-day and 90-day patient survivals

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 4, 2011
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.