Fluid Intake in Kidney Failure

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00842322
First received: February 11, 2009
Last updated: February 12, 2009
Last verified: February 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Martin Haas, MD, Medical University Vienna
ClinicalTrials.gov Identifier: NCT00842322     History of Changes
Other Study ID Numbers: OFS1
Study First Received: February 11, 2009
Last Updated: February 12, 2009
Health Authority: Austria: Agency for Health and Food Safety

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

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

ClinicalTrials.gov processed this record on October 20, 2014