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Fluid Intake in Kidney Failure

Primary Purpose

Chronic Renal Failure, Kidney Transplantation

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

high fluid intake

normal fluid intake

About this trial

This is an interventional treatment trial for Chronic Renal Failure focused on measuring chronic kidney disease, transplantation, kidney function, fluid intake, osmolarity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medical University Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

High fluid intake

normal fluid intake

Arm Description

fluid intake of 4 litres per day

Fluid intake of 2 litres per day

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00842322

First Posted

February 11, 2009

Last Updated

February 12, 2009

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT00842322

Brief Title

Fluid Intake in Kidney Failure

Official Title

The Effect of Increased Fluid Intake on Chronic Renal Failure

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Medical University of Vienna

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Renal Failure, Kidney Transplantation

Keywords

chronic kidney disease, transplantation, kidney function, fluid intake, osmolarity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High fluid intake

Arm Type

Experimental

Arm Description

fluid intake of 4 litres per day

Arm Title

normal fluid intake

Arm Type

Experimental

Arm Description

Fluid intake of 2 litres per day

Intervention Type

Behavioral

Intervention Name(s)

high fluid intake

Intervention Description

fluid intake of 4 litres per day

Intervention Type

Behavioral

Intervention Name(s)

normal fluid intake

Intervention Description

Fluid intake of 2 litres per day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin Haas, MD

Organizational Affiliation

Medical University Vienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University Vienna

City

Vienna

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

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Fluid Intake in Kidney Failure

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