The effect of Membrane Permeability on End-Stage Renal Disease (ESRD) patient Outcome

Completed

Conditions: Chronic kidney disease stage 5
Urological and Genital Diseases

Registration Number: ISRCTN43474447

Lead Sponsor: Fresenius Medical Care (Germany)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 666

Inclusion Criteria

1. Age between 18 and 80 years old
2. Up to two months on renal replacement therapy

Exclusion Criteria

1. Scheduled for renal transplantation from a living donor within the period of the study
2. On hemodialysis after renal transplantation
3. Serious clinical conditions:
3.1. Nephrotic syndrome
3.2. Active malignancies
3.3. Current therapy with immunosuppressive agents
3.4. Severe congestive heart failure despite maximal therapy (New York Heart Association [NYHA] class IV)
3.5. Unstable angina pectoris
3.6. Active systemic infections (i.e. tuberculosis, systemic fungal infection, AIDS, hepatitis)
3.7. Chronic pulmonary disease requiring supplementary oxygen
3.8. Cirrhosis with encephalopathy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality, determined upon occurence throughout the complete study period.

Secondary Outcome Measures

Name	Time	Method
1. Mortality due to infections<br>2. Mortality due to cardiovascular causes<br>3. Morbidity due to all causes<br>4. Morbidity due to infections<br>5. Morbidity due to problems related to vascular access<br>6. Pre-dialysis beta2-microglobulin levels<br>7. Pre-dialysis plasma levels of Advanced Glycosylation End-products (AGE)<br>8. Hematocrit levels and related rHu-EPO dose<br>9. Triglycerides and the High Density Lipoproteins (HDL) / Low Density Lipoprotein (LDL) cholesterol ratio<br>10. Pre-dialysis bicarbonate<br>11. Nutritional parameters<br>12. Protein Catabolic Rate (PCR)<br>13. Residual renal function<br><br>1 to 5 above were determined upon occurence throughout the complete study period, and the other parameters in 6-monthly intervals.