Compare usual care in patients with treatment resistant heart failure with additional ultrafiltration by peritoneal dialysis.
ID
Source
Brief title
Condition
- Heart failures
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Hospitalization days
Secondary outcome
Mortality
Quality of life
Cardiac function
Residual renal function and urine production
Nutrition
Background summary
The prevalence of end-stage heart failure with recurrent hospitalizations is
rising. The possibility of ultrafiltration by peritoneal dialysis will be
studied in this study. We compare standard pharmacological treatment with
nocturnal peritoneal dialysis as an additional treatment in treatment-resistant
patients with congestive heart failure. We suppose the last treatment is
superior on hospitalization rate, quality of life and survival.
Study objective
Compare usual care in patients with treatment resistant heart failure with
additional ultrafiltration by peritoneal dialysis.
Study design
Prospective multicentre randomised trial.
Intervention
group I standard farmacological treatment
group II additional nocturnal peritoneal dialysis
Study burden and risks
Group 1: standard care
Group 2: placement of peritoneal dialysis catheter. After training, start
peritoneal dialysis with an overnight exchange
Visits: every six weeks, within the regular visits.
Bloodsamples: every six weeks
During visits:
• every 3 months: Quality of life questonaire, 24-urine analysis, hand grip
dynamometry
• every six months: 6 minute walking test, echocardiogram: 1 extra / year
Risk's
Patients in group 1 get the standard treatment, no extra risk's.
Patients in group 2
a. Operation risk. Low due to the small operation.
b. Catheter related complications:
- Obstipation, pericatheter leakage (1-20%), cuff extrusion (3-15%), abdominal
wall herniation (<0,1%)
- exit site infection and bacterial peritonitis (1 per 2 patient years)
De Boelelaan 1117
1081 HV
NL
De Boelelaan 1117
1081 HV
NL
Listed location countries
Age
Inclusion criteria
• Severe refractory congestive heart failure with signs of diuretic resistance which is defined as the inability to preserve euvolemia despite maximal diuretic therapy
• Dyspnoe NYHA class III and IV
• Not fit for resynchronisation therapy or patients with relapse of diuretic resistance after resynchronisation therapy
• Age at least 18 years.
• Capable of giving informed consent.
Exclusion criteria
1. Fit for resynchronisation therapy
2. On the heart transplant waiting list
3. Contraindications for peritoneal dialysis: history of multiple abdominal operations
4. MDRD < 10 or > 30 ml/min
5. Severe comorbidity with life expectancy less than 1 year
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31323.029.10 |