Chronic Renal FailureNCT00842322
Fluid Intake in Kidney Failure
A study testing high fluid intake and normal fluid intake in people with Chronic Renal Failure and Kidney Transplantation, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Renal Failure, Kidney Transplantation
- What is being tested?
- high fluid intake and normal fluid intake
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteAustria
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Therapy resistant edema
- Severe pulmonary disease
- Mean arterial pressure (MAP) > 120 mm Hg
- Pregnancy
- Kidney transplantation within three months prior to randomization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Renal Failure, Kidney Transplantation
- Being tested
- high fluid intake, normal fluid intake
- Keywords
- chronic kidney disease, transplantation, kidney function, fluid intake, osmolarity
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high fluid intakeBehavioural
fluid intake of 4 litres per day
normal fluid intakeBehavioural
Fluid intake of 2 litres per day
| Study group | Role | What they receive |
|---|---|---|
| High fluid intake | Experimental | fluid intake of 4 litres per day Receives: Behavioral: high fluid intake |
| normal fluid intake | Experimental | Fluid intake of 2 litres per day Receives: Behavioral: normal fluid intake |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Martin Haas, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842322
- Sponsor's protocol ID
- OFS1
- Status last verified
- Feb 2009
- First submitted
- 11 Feb 2009
- Last updated
- 13 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Increased Fluid Intake on Chronic Renal Failure
- ClinicalTrials.gov ID
- NCT00842322
- Acronym / sponsor ID
- OFS1
- Conditions
- Chronic Renal Failure, Kidney Transplantation
- Keywords
- chronic kidney disease, transplantation, kidney function, fluid intake, osmolarity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- First posted
- 12 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High fluid intake | Experimental | Behavioral: high fluid intakefluid intake of 4 litres per day |
| normal fluid intake | Experimental | Behavioral: normal fluid intakeFluid intake of 2 litres per day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- Therapy resistant edema
- Severe pulmonary disease
- Mean arterial pressure (MAP) > 120 mm Hg
- Pregnancy
- Kidney transplantation within three months prior to randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high fluid intakefluid intake of 4 litres per day | Behavioural | High fluid intake |
| normal fluid intakeFluid intake of 2 litres per day | Behavioural | normal fluid intake |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Haas, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high fluid intake and normal fluid intake in people with Chronic Renal Failure and Kidney Transplantation, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2009.