Citrate Versus Heparin for the Lock of Non-tunneled Hemodialysis Catheters in Patients Hospitalised in ICU

NCT ID: NCT01962116

Last Updated: 2018-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

405 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-14

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

After obtaining written informed consent and inclusion, patients will be randomised into 2 groups for the type of dialysis catheter lock:

* The first group will have a citrate lock
* The second group will have a heparin lock Patients will be stratified according to the centre and type of Renal Replacement Therapy (RRT) continuous or intermittent.

The daily surveillance of patients will not be different from the usual surveillance of patients on Renal Replacement Therapy.

The hemodialysis catheters used will be specific Renal Replacement Therapy catheters.

The decision to withdraw the catheter will be made by the investigator and based on clinical criteria (complications related to the catheter, termination of Renal Replacement Therapy…)

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patients With Acute Renal Insufficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Heparin lock

Group Type PLACEBO_COMPARATOR

unfractionated heparin

Intervention Type DRUG

Citrate lock

Group Type EXPERIMENTAL

Citrate 4%

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Citrate 4%

Intervention Type DRUG

unfractionated heparin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients aged \> 18 years
* Requiring RRT for acute renal insufficiency
* For which a 1st non-tunneled catheter is placed
* In the jugular or femoral position
* After written informed consent has been obtained from the patient, a member of the family or a person of trust

Exclusion Criteria

* Patient presenting active poorly controlled bleeding
* Known allergy to citrate
* Acute liver failure (Prothrombin level \<30%)
* Thrombopenia \< 30 000/mm3
* Known or suspected heparin-induced thrombopenia
* Known systemic bacterial infection at the time the catheter is placed
* catheter in the subclavicular position
* Persons not affiliated to a national health insurance scheme
* Pregnant women
* Adults under guardianship
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Dijon

Dijon, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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)

Quenot JP, Helms J, Bourredjem A, Dargent A, Meziani F, Badie J, Blasco G, Piton G, Capellier G, Mezher C, Rebibou JM, Nadji A, Crepin T, Barbar SD, Fleck C, Cransac A, Boulin M, Binquet C, Soudry-Faure A, Bruyere R; VERROU-REA Trial Investigators and the CRICS TRIGGERSEP Group (Clinical Research in Intensive Care and Sepsis Trial Group for Global Evaluation and Research in Sepsis). Trisodium citrate 4% versus heparin as a catheter lock for non-tunneled hemodialysis catheters in critically ill patients: a multicenter, randomized clinical trial. Ann Intensive Care. 2019 Jul 1;9(1):75. doi: 10.1186/s13613-019-0553-4.

Reference Type DERIVED
PMID: 31264073 (View on PubMed)

Bruyere R, Soudry-Faure A, Capellier G, Binquet C, Nadji A, Torner S, Blasco G, Yannaraki M, Barbar SD, Quenot JP. Comparison of heparin to citrate as a catheter locking solution for non-tunneled central venous hemodialysis catheters in patients requiring renal replacement therapy for acute renal failure (VERROU-REA study): study protocol for a randomized controlled trial. Trials. 2014 Nov 19;15:449. doi: 10.1186/1745-6215-15-449.

Reference Type DERIVED
PMID: 25409678 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

QUENOT DB 2012

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.