Dialysis lock leak study raises safety questions
NCT ID NCT02860299
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether heparin or citrate locks used in dialysis catheters leak into the bloodstream. It involves 76 adults with acute kidney failure. Researchers measure blood clotting and calcium levels before and after injecting the lock to check for leakage and potential risks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- citrate 4% and unfractionated heparin
- What this could lead to
- If successful, this could improve safety guidelines for catheter locks in dialysis patients.
- What could go wrong
- This is a small, completed ancillary study with only 76 participants, so results may not apply broadly. It measures biological markers, not direct patient outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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76 people
The number who actually took part.
- Start date
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Feb 2015
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient aged \> 18 years * Requiring dialysis for acute kidney failure * In whom a first non-tunnelled catheter has been inserted * In the jugular or femoral position * Once informed consent has been obtained from the patient, a family member or a person of trust Exclusion Criteria: * Patients with active and poorly-controlled bleeding * Known allergy to citrate * Liver failure (Factor V \<30%) * Thrombopenia \< 30 000/mm3 in the absence of planned corrective measures at the time of randomization * Known or suspected heparin-induced thrombopenia * Positive blood cultures without treatment or with inappropriate treatment at the time of randomization * Catheter inserted in the subclavian position * Person without national health insurance cover * Pregnant women * Adults under guardianship
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHU Dijon Bourgogne
Dijon, 21079, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.