Trials / Terminated
TerminatedNCT02708407
PD-HF: A Trial of Peritoneal Dialysis in Patients With Severe Heart Failure and Chronic Kidney Disease
PD-HF: A Multi-centre Randomised Controlled Trial of Intermittent Peritoneal Dialysis With Icodextrin-based Solutions on Patients With Severe Heart Failure and Stage 3-4 Chronic Kidney Disease
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- University of Nottingham · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This trial is to establish whether ultrafiltration by peritoneal dialysis is a clinically effective treatment for patients with severe heart failure and moderate chronic kidney disease, thus improving quality of life and symptoms.
Detailed description
The trial is a multi-centre, prospective, randomised, unblended, controlled trial of intermittent PD with a single daily exchange of icodextrin plus best standard care versus best standard care for the treatment of severe HF and moderate CKD. A second exchange with glucose based solution may be given, should it be required in the investigator's/clinician's opinion. Investigators will randomise 130 participants for 32 weeks with randomisation stratified by participating centre. Participants will be recruited from specialist-led outpatient HF services in 6 NHS trusts and be managed by both cardiologists and nephrologists. PD catheter insertion will occur according to the participating centre's institutional protocol. Treatment begins 1 week after catheter insertion and consists of a single nightly exchange.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Peritoneal Dialysis | One week after insertion of a PD catheter the intervention group will received a single nightly exchange, using dialysis fluid containing icodextrin; a variable proportion of participants may require a second exchange as directed by the consultant nephrologist as part of routine care. The second exchange would use dialysis fluid containing glucose, not icodextrin. Support and training will be given to each participant by the PD specialist team. |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2017-06-01
- Completion
- 2017-06-01
- First posted
- 2016-03-15
- Last updated
- 2020-01-23
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02708407. Inclusion in this directory is not an endorsement.