NCT00842322

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
Last Updated

February 13, 2009

Status Verified

February 1, 2009

First QC Date

February 11, 2009

Last Update Submit

February 12, 2009

Conditions

Chronic Renal FailureKidney Transplantation

Keywords

chronic kidney diseasetransplantationkidney functionfluid intakeosmolarity

Study Arms (2)

High fluid intake

EXPERIMENTAL

fluid intake of 4 litres per day

Behavioral: high fluid intake

normal fluid intake

EXPERIMENTAL

Fluid intake of 2 litres per day

Behavioral: normal fluid intake

Interventions

high fluid intakeBEHAVIORAL

fluid intake of 4 litres per day

High fluid intake
normal fluid intakeBEHAVIORAL

Fluid intake of 2 litres per day

normal fluid intake

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Therapy resistant edema
  • Severe pulmonary disease
  • Mean arterial pressure (MAP) \> 120 mm Hg
  • Pregnancy
  • Kidney transplantation within three months prior to randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Kidney Failure, ChronicRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Martin Haas, MD

    Medical University Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 11, 2009

First Posted

February 12, 2009

Last Updated

February 13, 2009

Record last verified: 2009-02

Locations

AU(1)