Fluid Intake in Kidney Failure

NCT ID: NCT00842322

Last Updated: 2009-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Renal Failure Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High fluid intake

fluid intake of 4 litres per day

Group Type EXPERIMENTAL

high fluid intake

Intervention Type BEHAVIORAL

fluid intake of 4 litres per day

normal fluid intake

Fluid intake of 2 litres per day

Group Type EXPERIMENTAL

normal fluid intake

Intervention Type BEHAVIORAL

Fluid intake of 2 litres per day

Interventions

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high fluid intake

fluid intake of 4 litres per day

Intervention Type BEHAVIORAL

normal fluid intake

Fluid intake of 2 litres per day

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Medical University Vienna

Principal Investigators

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Martin Haas, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University Vienna

Locations

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Medical University Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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OFS1

Identifier Type: -

Identifier Source: org_study_id

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