NCT00286273

Brief Summary

Severely ill patients admitted to the intensive care unit may develop an acute failure of kidney function. To bridge the period to recovery, renal function is temporarily replaced by continuous venovenous hemofiltration (CVVH). To prevent clotting of the hemofiltration circuit, heparin is generally used, providing anticoagulation in the circuit and the patient. As a result, bleeding complications may occur, necessitating the transfusion of blood. Anticoagulation of the circuit can also be obtained with the use of tri-sodium citrate, which provides anticoagulation of the circuit without affecting coagulation in the patient and thus without increasing his/her risk of bleeding. The use of citrate may however cause metabolic complications. Primary aim of the present study is to show in a larger group of intensive care patients whether the use of regional anticoagulation with citrate is safe compared to systemic anticoagulation with the low molecular weight heparin nadroparin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
215

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2003

Longer than P75 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

March 1, 2003

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

August 26, 2009

Status Verified

August 1, 2009

Enrollment Period

4.8 years

First QC Date

February 1, 2006

Last Update Submit

August 25, 2009

Conditions

Kidney Failure, Acute

Keywords

kidney failure, acutevenovenous hemofiltrationhemorrhageheparin, low-molecular-weightnadroparincitrates

Outcome Measures

Primary Outcomes (3)

  • bleeding complications

    during administration of study anticoagulant

  • transfusion requirement

    during administration of study anticoagulant

  • filter survival

    during hemofiltration

Secondary Outcomes (1)

  • mortality

    3-month and hospital admission

Study Arms (2)

citrate

ACTIVE COMPARATOR

regional anticoagulation with citrate

Drug: trisodium citrate

nadroparin

ACTIVE COMPARATOR

nadroparin is a low molecular weight heparin

Drug: nadroparin

Interventions

trisodium citrateDRUG

for regional anticoagulation of the extracorporeal CVVH circuit

Also known as: regional anticoagulation with citrate
citrate
nadroparinDRUG

for anticoagulation of the extracorporeal CVVH circuit

Also known as: nadroparin is a low molecular weight heparin
nadroparin

Eligibility Criteria

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

You may qualify if:

  • Intensive care patients scheduled for continuous venovenous hemofiltration

You may not qualify if:

  • Active bleeding or bleeding necessitating the infusion of two red blood cell units within 24 hours before starting hemofiltration or a fall in hemoglobin of \> 0.5 mmol/l. A fall in hemoglobin/hematocrit as a result of fluid loading is not regarded as bleeding.
  • Surgery within 24 h prior to CVVH.
  • Patients needing full systemic anticoagulation (unfractionated heparin in a dose of \> 10000 IU/day, or nadroparin \> 3800 IU/day) for other reasons
  • Expectation to die within 24 hours
  • Chronic dialysis
  • Proven or suspected heparin-induced thrombocytopenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1090HM, Netherlands

Location

Related Publications (2)

  • Oudemans-van Straaten HM, Bosman RJ, Koopmans M, van der Voort PH, Wester JP, van der Spoel JI, Dijksman LM, Zandstra DF. Citrate anticoagulation for continuous venovenous hemofiltration. Crit Care Med. 2009 Feb;37(2):545-52. doi: 10.1097/CCM.0b013e3181953c5e.

    PMID: 19114912RESULT

  • 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

MeSH Terms

Conditions

Acute Kidney InjuryHemorrhage

Interventions

trisodium citrateCitric AcidNadroparin

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CitratesTricarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHeparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Heleen M Oudemans-van Straaten, MD,PhD

    Onze Lieve Vrouwe Gasthuis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 1, 2006

First Posted

February 3, 2006

Study Start

March 1, 2003

Primary Completion

January 1, 2008

Study Completion

March 1, 2008

Last Updated

August 26, 2009

Record last verified: 2009-08

Locations

NL(1)