Fluid Intake in Kidney Failure

February 12, 2009 updated by: Medical University of Vienna

The Effect of Increased Fluid Intake on Chronic Renal Failure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Martin Haas, MD, Medical University Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 11, 2009

First Submitted That Met QC Criteria

February 11, 2009

First Posted (Estimate)

February 12, 2009

Study Record Updates

Last Update Posted (Estimate)

February 13, 2009

Last Update Submitted That Met QC Criteria

February 12, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OFS1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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