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NCT00842322 Clinical Trial

Fluid Intake in Kidney Failure

Kidney Transplantation Clinical Trial

Official title:
The Effect of Increased Fluid Intake on Chronic Renal Failure

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00842322
Other study ID # OFS1
Secondary ID
Status Completed
Phase N/A
First received February 11, 2009
Last updated February 12, 2009

Study information
Verified date February 2009
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food Safety
Study type Interventional

Clinical Trial Summary

Patients with renal impairment are usually advised to increase their fluid intake. There is currently, however, no evidence supporting this recommendation. In contrast,high fluid intake could be dangerous if urine excretion is reduced. In this study the researchers investigate whether increasing fluid intake from 2 to 4 litres per day has any influence on long-term renal outcome.

Recruitment information / eligibility
Status Completed
Enrollment 76
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Patients with native kidney disease or chronic kidney transplant failure

- An effective glomerular filtration rate (eGFR) according the MDRD formula between 20 and 75ml/min/1.73m2

- Ejection fraction >20%

- Absence of liver cirrhosis or ascites

- No evidence of active glomerulonephritis or immunosuppressive therapy if native kidney disease

- Acute transplant rejection

- Urinary protein excretion below 3g/d

- Age between 18 and 70 years.

Exclusion Criteria:

- Therapy resistant edema

- Severe pulmonary disease

- Mean arterial pressure (MAP) > 120 mm Hg

- Pregnancy

- Kidney transplantation within three months prior to randomization

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• high fluid intake
fluid intake of 4 litres per day
• normal fluid intake
Fluid intake of 2 litres per day

Locations
Country Name City State
Austria Medical University Vienna Vienna

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

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