Renal FailurePhase 3NCT00298454
Forced Diuresis Versus Observation in Resolving Renal Failure After Haemofiltration in Critically Ill Patients
A Phase 3 study testing Furosemide in people with Renal Failure and Critically Ill, run by Frisius Medisch Centrum at 1 site in Netherlands.
Trial summary
Intensive care patients with multiple organ dysfunction syndrome often show renal failure with the need for hemofiltration. Resolving renal failure after cessation of hemofiltration may or may not be accompanied by oliguria. Whether or not the administration of diuretics at that moment is appropriate is not known. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure, Critically Ill
- What is being tested?
- Furosemide
- How many people
- 72 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2005to Apr 2007
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cessation of hemofiltration
- mechanical ventilation
- written informed consent
Who cannot join
- pre-existent renal failure
- glomerulonephritis
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Dept of intensive care, Medical Centre Leeuwarden
Leeuwarden, Provincie Friesland, 8901 BR
About this study
Official title: Forced Diuresis Vs Observation in Resolving Renal Failure After Haemofiltration in Critically Ill Patients (Fodorefh)
Intensive care patients with multiple organ dysfunction syndrome often show renal failure with the need for hemofiltration. Resolving renal failure after cessation of hemofiltration may or may not be accompanied by oliguria. Whether or not the administration of diuretics at that moment is appropriate is not known. The study randomises between furosemide or placebo when hemofiltration is stopped. Study endpoint is recovery of renal function.
Read the detailed description
Introduction:
Virtually all intensive care (IC) patients with prolonged IC stay have multiple organ dysfunction syndrome. Frequently renal failure is present. The resolution of renal failure is often relatively late. After cessation of hemofiltration, oliguria may be present, at least for some time. Increasing diuresis by diuretics will probably increase clearance. As a result, intensive care stay and outcome may improve. However, diuretics might also be harmful as it is when applied in developing renal failure.
Aim of the study:
To study whether the stimulation of diuresis by furosemide when hemofiltration is stopped enhances renal recovery and secondary shortens the length of IC-stay.
Setting:
IC-patients treated at the Medical Centre Leeuwarden with MODS and renal failure are included when hemofiltration is stopped. The ICU is mixed medical and surgical, 16 beds with full time intensivists responsible for hemofiltration.
Study design:
Prospective randomised placebo controlled single centre trial.
Methods:
Inclusion criteria. Patients with mechanical ventilation in whom hemofiltration is stopped. Written informed consent must be obtained.
Excluded are patients with pre-existent serum creatinin of 150 umol/l or clearance less than 30 ml/min. Patients admitted with renal failure as the primary admission diagnosis in case acute renal failure is due to glomerulonephritis.
Creatinin clearance is measured in a 4 hour period directly after cessation of hemofiltration. The patient is then randomised for furosemide or sodium chloride. Furosemide is administered at 0.5 mg/kg/hour. Dehydration is prevented by infusing the patient the volume of their diuresis.
Daily creatinin clearance is calculated.
Primary endpoints:
- Recovery of renal function (clearance more than 30 ml/min)
- Stable or declining serum creatinin in case of persistent clearance less than 30 ml/min
- Need for re-start of renal replacement therapy (metabolic acidosis, hyperkalaemia, fluid overload, uremia or uremic complications)
Secondary endpoints:
Length of stay ICU, mortality.
Poweranalysis:
36 patients per group for alpha 0.05 and beta 0.8 and 30% faster recovery of renal failure for the intervention group.
Statistical analysis:
Student t for normally distributed variables, otherwise non-parametric tests. Kaplan Meier and Cox regression for time to recovery of renal function.
- Conditions
- Renal Failure, Critically Ill
- Being tested
- Furosemide
- Keywords
- renal failure, oliguric, critically ill, furosemide
- Medical subject headings
- Renal Insufficiency, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurosemideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Creatinin clearance
Secondary outcomes (2)
length of stay in the intensive care and hospital
intensive care and hospital mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2006 (estimated)
- Study startDec 2005
- Study completionApr 2007
Why it stopped: Number included has been reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 72 participants
Sponsor and investigators
- Lead sponsor
- Frisius Medisch Centrum
- Sponsor type
- University, hospital or other
- Investigators
- Peter van der Voort, MD, PhD, MSc, Principal investigator, Dept of intensive care, Medical Centre Leeuwarden, PO Box 888,8901BR Leeuwarden, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298454
- Sponsor's protocol ID
- 200601
- Status last verified
- Apr 2007
- First submitted
- 1 Mar 2006
- Last updated
- 19 Apr 2007
- Results posted
- No
Publications
Hashimoto H, Yamada H, Murata M, Watanabe N. Diuretics for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2025 Jan 29;1(1):CD014937. doi: 10.1002/14651858.CD014937.pub2.
PubMed 39878152van der Voort PH, Boerma EC, Koopmans M, Zandberg M, de Ruiter J, Gerritsen RT, Egbers PH, Kingma WP, Kuiper MA. Furosemide does not improve renal recovery after hemofiltration for acute renal failure in critically ill patients: a double blind randomized controlled trial. Crit Care Med. 2009 Feb;37(2):533-8. doi: 10.1097/CCM.0b013e318195424d.
PubMed 19114909
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forced Diuresis Vs Observation in Resolving Renal Failure After Haemofiltration in Critically Ill Patients (Fodorefh)
- ClinicalTrials.gov ID
- NCT00298454
- Acronym / sponsor ID
- 200601
- Conditions
- Renal Failure, Critically Ill
- Keywords
- renal failure, oliguric, critically ill, furosemide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Number included has been reached
- Enrolment
- 72 participants
- Lead sponsor
- Frisius Medisch CentrumUniversity, hospital or other
- Study start
- Dec 2005
- Study completion
- Apr 2007 (actual)
- First posted
- 2 Mar 2006 (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.
Intensive care patients with multiple organ dysfunction syndrome often show renal failure with the need for hemofiltration. Resolving renal failure after cessation of hemofiltration may or may not be accompanied by oliguria. Whether or not the administration of diuretics at that moment is appropriate is not known. The study randomises between furosemide or placebo when hemofiltration is stopped. Study endpoint is recovery of renal function.
Detailed description
Introduction:
Virtually all intensive care (IC) patients with prolonged IC stay have multiple organ dysfunction syndrome. Frequently renal failure is present. The resolution of renal failure is often relatively late. After cessation of hemofiltration, oliguria may be present, at least for some time. Increasing diuresis by diuretics will probably increase clearance. As a result, intensive care stay and outcome may improve. However, diuretics might also be harmful as it is when applied in developing renal failure.
Aim of the study:
To study whether the stimulation of diuresis by furosemide when hemofiltration is stopped enhances renal recovery and secondary shortens the length of IC-stay.
Setting:
IC-patients treated at the Medical Centre Leeuwarden with MODS and renal failure are included when hemofiltration is stopped. The ICU is mixed medical and surgical, 16 beds with full time intensivists responsible for hemofiltration.
Study design:
Prospective randomised placebo controlled single centre trial.
Methods:
Inclusion criteria. Patients with mechanical ventilation in whom hemofiltration is stopped. Written informed consent must be obtained.
Excluded are patients with pre-existent serum creatinin of 150 umol/l or clearance less than 30 ml/min. Patients admitted with renal failure as the primary admission diagnosis in case acute renal failure is due to glomerulonephritis.
Creatinin clearance is measured in a 4 hour period directly after cessation of hemofiltration. The patient is then randomised for furosemide or sodium chloride. Furosemide is administered at 0.5 mg/kg/hour. Dehydration is prevented by infusing the patient the volume of their diuresis.
Daily creatinin clearance is calculated.
Primary endpoints:
- Recovery of renal function (clearance more than 30 ml/min)
- Stable or declining serum creatinin in case of persistent clearance less than 30 ml/min
- Need for re-start of renal replacement therapy (metabolic acidosis, hyperkalaemia, fluid overload, uremia or uremic complications)
Secondary endpoints:
Length of stay ICU, mortality.
Poweranalysis:
36 patients per group for alpha 0.05 and beta 0.8 and 30% faster recovery of renal failure for the intervention group.
Statistical analysis:
Student t for normally distributed variables, otherwise non-parametric tests. Kaplan Meier and Cox regression for time to recovery of renal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- cessation of hemofiltration
- mechanical ventilation
- written informed consent
Key exclusion criteria (2 listed)
- pre-existent renal failure
- glomerulonephritis
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 |
|---|---|---|
| Furosemide | Drug | – |
Primary outcome
Creatinin clearance
2 secondary outcomes
length of stay in the intensive care and hospital
intensive care and hospital mortality
Results and safety
The study was stopped early (reason given: Number included has been reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2007.
- Derived from this study: PubMed 39878152Hashimoto H, Yamada H, Murata M, Watanabe N. Diuretics for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2025 Jan 29;1(1):CD014937. doi: 10.1002/14651858.CD014937.pub2.
- Derived from this study: PubMed 19114909van der Voort PH, Boerma EC, Koopmans M, Zandberg M, de Ruiter J, Gerritsen RT, Egbers PH, Kingma WP, Kuiper MA. Furosemide does not improve renal recovery after hemofiltration for acute renal failure in critically ill patients: a double blind randomized controlled trial. Crit Care Med. 2009 Feb;37(2):533-8. doi: 10.1097/CCM.0b013e318195424d.
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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.
Peter van der Voort, MD, PhD, MSc principal investigator
Dept of intensive care, Medical Centre Leeuwarden, PO Box 888,8901BR Leeuwarden, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Furosemide in people with Renal Failure and Critically Ill, run by Frisius Medisch Centrum at 1 site in Netherlands.
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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 19 Apr 2007. 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 Netherlands. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Number included has been reached). Results are not available in the source record.
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.
What does the primary outcome measure?
Creatinin clearance. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00298454, which also lists 2 linked publications.
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 19 Apr 2007.