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Fluid Intake in Kidney Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00842322
First Posted: February 12, 2009
Last Update Posted: February 13, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical University of Vienna
  Purpose
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.

Condition Intervention
Chronic Renal Failure Kidney Transplantation Behavioral: high fluid intake Behavioral: normal fluid intake

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Increased Fluid Intake on Chronic Renal Failure

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Enrollment: 76
Arms Assigned Interventions
Experimental: High fluid intake
fluid intake of 4 litres per day
Behavioral: high fluid intake
fluid intake of 4 litres per day
Experimental: normal fluid intake
Fluid intake of 2 litres per day
Behavioral: normal fluid intake
Fluid intake of 2 litres per day

  Eligibility

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00842322


Locations
Austria
Medical University Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Martin Haas, MD Medical University Vienna
  More Information

Responsible Party: Martin Haas, MD, Medical University Vienna
ClinicalTrials.gov Identifier: NCT00842322     History of Changes
Other Study ID Numbers: OFS1
First Submitted: February 11, 2009
First Posted: February 12, 2009
Last Update Posted: February 13, 2009
Last Verified: February 2009

Keywords provided by Medical University of Vienna:
chronic kidney disease
transplantation
kidney function
fluid intake
osmolarity

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases