An interventional study of TaurolockTMHep100 and 0.9 % saline in Catheter Related Blood Stream Infections and Intestinal Failure, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-28.
Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Prevention
The purpose of the trial is to compare two catheter lock solutions (active: 1.35% taurolidine and placebo: 0.9% saline), on the occurence of catheter related blood stream infection, in patients with intestinal failure and a central venous catheter for home parenteral support.
Patients with long-term intestinal failure rely on Home Parenteral support (HPS) delivered through a central venous catheter(CVC). Catheter Related Blood Stream Infections(CRBSI) are a frequent complication leading to increased morbidity, hospital admissions, cost, and risk of repeated replacement of the CVC. The infections often originate from contamination of the catheter hub, and growth of microorganisms on the inner lumen of the catheter imbedded in a biofilm. To prevent infections good hygiene guidelines and the use of a catheter lock solution is applied.
The primary objective is to compare two catheter lock solutions, 1,35% taurolidine and 0.9% saline, on the occurence of recurrent CRBSIs. The secondary objectives are to compare the two devices according to other catheter-related complications, adverse events and costs.
Patients with at least one prior CRBSI is included. Patients instill the solution in their CVC after each infusion of HPS, with a minimum of three times per week, depending on their individual HPS programme.
Before the blinded randomization the patients will be paired according to age and stratified according to prior CRBSI incidence.
Duration of the instillation will be 24 months.
64 studies on the registry are indexed under Intestinal Failure; 17 are open to participants now.
This study's enrollment of 61 is above the median of 38 across 42 interventional studies indexed under Intestinal Failure.
Browse Intestinal Failure studies →Rigshospitalet, Denmark is the lead sponsor of 1,007 studies on the registry; 175 are open to participants now.
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Patients receiving HPS at the department of Medical gastroenterology, Rigshospitalet, who have at least one prior CRBSI and thereby demonstrated susceptibility towards developing CRBSI while on HPS and the following:
Exclusion Criteria:
Patients who:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: TaurolockTMHep100
Device: 0.9 % saline
1.35% taurolidine containing catheter losk solution
placebo
Incidence of recurrent catheter-related bloodstream infections
Time frame: Treatment time 2 years
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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