NCT01269112

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

August 14, 2019

Status Verified

May 1, 2016

Enrollment Period

2.7 years

First QC Date

January 3, 2011

Last Update Submit

August 13, 2019

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • patient survival

    28-day and 90-day patient survivals

Study Arms (2)

heparin

PLACEBO COMPARATOR

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

Device: citrate regional anticoagulation

citrate regional anticoagulation

ACTIVE COMPARATOR

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

Device: citrate regional anticoagulation

Interventions

citrate regional anticoagulationDEVICE

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

heparin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)
  • Enrollment in another concurrent therapeutic trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Geneva

Geneva, 1211, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 33314078DERIVED

  • 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.

    PMID: 25881975DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr Patrick Saudan, MD

Study Record Dates

First Submitted

January 3, 2011

First Posted

January 4, 2011

Study Start

November 1, 2010

Primary Completion

July 1, 2013

Study Completion

November 1, 2013

Last Updated

August 14, 2019

Record last verified: 2016-05

Locations

CH(1)