Patients With Acute Renal InsufficiencyPhase 3VERROU-REANCT01962116
Citrate Versus Heparin for the Lock of Non-tunneled Hemodialysis Catheters in Patients Hospitalised in ICU
A Phase 3 study testing Citrate 4% and unfractionated heparin in people with Patients With Acute Renal Insufficiency, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Acute Renal Insufficiency
- What is being tested?
- Citrate 4% and unfractionated heparin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 405 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jun 2013to 31 Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- catheter in the subclavicular position
- Persons not affiliated to a national health insurance scheme
- Pregnant women
- Adults under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Citrate Versus Heparin for the Lock of Non-tunneled Hemodialysis Catheters in Patients Hospitalised in ICU = Multicentre, Controlled, Randomised Superiority Trial
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.
Read more
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…)
- Conditions
- Patients With Acute Renal Insufficiency
- Being tested
- Citrate 4%, unfractionated heparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citrate 4%Drug
unfractionated heparinDrug
| Study group | Role | What they receive |
|---|---|---|
| Heparin lock | Placebo comparator | Not described Receives: Drug: unfractionated heparin |
| Citrate lock | Experimental | Not described Receives: Drug: Citrate 4% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of event-free survival of the first non-tunneled hemodialysis catheter (defined at the time in days from catheter insertion to withdrawal whatever the reason)
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study start14 Jun 2013
- Primary completion1 Apr 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patients With Acute Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962116
- Sponsor's protocol ID
- QUENOT DB 2012
- Acronym
- VERROU-REA
- Status last verified
- Feb 2026
- First submitted
- 27 Aug 2013
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31264073Tsujimoto 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.
PubMed 33314078Bruyere 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.
PubMed 25409678
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Citrate Versus Heparin for the Lock of Non-tunneled Hemodialysis Catheters in Patients Hospitalised in ICU = Multicentre, Controlled, Randomised Superiority Trial
- ClinicalTrials.gov ID
- NCT01962116
- Acronym / sponsor ID
- VERROU-REA / QUENOT DB 2012
- Conditions
- Patients With Acute Renal Insufficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 14 Jun 2013 (actual)
- Primary completion
- 1 Apr 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 14 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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…)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heparin lock | Placebo comparator | Drug: unfractionated heparin |
| Citrate lock | Experimental | Drug: Citrate 4% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Citrate 4% | Drug | Citrate lock |
| unfractionated heparin | Drug | Heparin lock |
Primary outcome
Duration of event-free survival of the first non-tunneled hemodialysis catheter (defined at the time in days from catheter insertion to withdrawal whatever the reason)
Time frame: up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Results publication: PubMed 31264073Quenot 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.
- Derived from this study: PubMed 33314078Tsujimoto 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.
- Derived from this study: PubMed 25409678Bruyere 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Citrate 4% and unfractionated heparin in people with Patients With Acute Renal Insufficiency, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of event-free survival of the first non-tunneled hemodialysis catheter (defined at the time in days from catheter insertion to withdrawal whatever the reason) (time frame: up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01962116, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.