Percutaneous Peritoneal Dialysis Catheter Insertion (PREDICT)

Status Recruiting

Clinical Trial Summary

Peritoneal dialysis (PD) is the most frequent modality of home dialysis for patients with kidney failure. Most PD catheters are placed using a laparoscopic technique. This approach requires the availability of a qualified surgeon, time in the operating theater and general anaesthesia for the patient. Thus, the laparoscopic technique is less suitable for patients with severe heart failure or multimorbidity where general anaesthesia is not possible. PD catheters can also be inserted using a percutaneous strategy using a modified Seldinger technique. This strategy can be performed bedside under local anaesthesia, by the nephrologist, radiologist, a surgeon, physician assistant or qualified nurse. The availability of the percutaneous implantation strategy of a PD catheter in a nephrology center may accomodate more patients to receive a PD catheter insertion, including those who have a contraindication to general anaesthesia or need urgent PD. The PREDICT project aims to increase knowledge and competencies on percutaneous PD catheter insertions by training centers for this technique. By establisching a prospective registry, the outcomes of percutaneously inserted PD catheters, both in experienced and newly trained centers, will be assessed.

Clinical Trial Description

The population of the PREDICT study are adult patients requiring a peritoneal dialysis catheter insertion. Decision for percutaneous strategy of catheter insertion (versus surgical catheter insertion) is made by the treating physician. The inclusion criteria for the prospective PREDICT registry are age > 18 years and percutaneous PD catheter insertion between 1 March 2023 and 1 March 1 2026 in participating centers. Patients can be included 4 weeks before until 12 weeks after PD catheter insertion. The exclusion criteria are the inability to give informed consent and a life expectancy of less than 3 months. Demographic and clinical data will be collected for all included patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06065982
Study type	Observational [Patient Registry]
Source	Universitair Ziekenhuis Brussel
Contact	Karlien François, MD PhD
Phone	+324776055
Email	Karlien.Francois@uzbrussel.be
Status	Recruiting
Phase
Start date	June 23, 2023
Completion date	June 23, 2027

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Percutaneous Peritoneal Dialysis Catheter Insertion (PREDICT) — PREDICT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms