Fluid Intake in Kidney Failure
Primary Purpose
Chronic Renal Failure, Kidney Transplantation
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
high fluid intake
normal fluid intake
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Renal Failure focused on measuring chronic kidney disease, transplantation, kidney function, fluid intake, osmolarity
Eligibility Criteria
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
Sites / Locations
- Medical University Vienna
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
High fluid intake
normal fluid intake
Arm Description
fluid intake of 4 litres per day
Fluid intake of 2 litres per day
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00842322
First Posted
February 11, 2009
Last Updated
February 12, 2009
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT00842322
Brief Title
Fluid Intake in Kidney Failure
Official Title
The Effect of Increased Fluid Intake on Chronic Renal Failure
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure, Kidney Transplantation
Keywords
chronic kidney disease, transplantation, kidney function, fluid intake, osmolarity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High fluid intake
Arm Type
Experimental
Arm Description
fluid intake of 4 litres per day
Arm Title
normal fluid intake
Arm Type
Experimental
Arm Description
Fluid intake of 2 litres per day
Intervention Type
Behavioral
Intervention Name(s)
high fluid intake
Intervention Description
fluid intake of 4 litres per day
Intervention Type
Behavioral
Intervention Name(s)
normal fluid intake
Intervention Description
Fluid intake of 2 litres per day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Haas, MD
Organizational Affiliation
Medical University Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
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Fluid Intake in Kidney Failure
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