Randomised controlled trial of the benefits of oral essential amino acids in haemodialysis patients at high risk for hospitalisatio
Completed
- Conditions
- End Stage Renal Disease (ESRD), and haemodialysisUrological and Genital DiseasesRenal Disease
- Registration Number
- ISRCTN21593740
- Lead Sponsor
- Recip AB (Sweden)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
1. Patients on maintenance haemodialysis for at least four months at high risk of hospitalisation. This is defined as:
a. no more than two weeks post discharge from an acute hospitalisation and a serum albumin below 4.0 g/dl
b. a serum albumin below 3.8 g/dl
Exclusion Criteria
1. Patients who have difficulties in taking pills, due to problems swallowing or intractable vomiting
2. Patients who have a short time life expectancy or are awaiting non-cadaveric kidney transplantation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome was comparing the time of the composite primary outcome of :<br>1. Hospitalisation, other than for uncomplicated dialysis access procedure<br>2. Prolonged Emergency Room (ER) visit (more than 16 hours)<br>3. Out of hospital death
- Secondary Outcome Measures
Name Time Method Secondary efficacy analyses, for the following outcomes comparing the change in the given parameter from baseline to the last available study measurement:<br>1. Change in subjective global assessment<br>2. Change in grip strength<br>3. Change in quality of life measures (using Short Form 12 instrument)<br>4. Change in lowest post dialysis weight