Acute Decompensated Heart FailurePhase 3CRUFNCT01138683
Cardiorenal Interactions During Treatment of Acute Decompensated Heart Failure: Diuretics Versus Ultrafiltration
A Phase 3 study testing ultrafiltration and diuretics in people with Acute Decompensated Heart Failure, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The CRUF trial is a prospective randomized monocentric trial comparing different impact of diuretics versus ultrafiltration on renal congestion, plasma refill rate, echocardiographic filling pressures, neurohormonal activation and biomarkers of Acute Kidney Injury (AKI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure
- What is being tested?
- ultrafiltration and diuretics
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2010to Dec 2011
- 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
- >18 years old
- Severe systolic heart failure with ejection fraction <40%
- And Hospitalisation for decompensated heart failure
- And New York Heart Association (NYHA) III or IV
- And 1 of the following:
- Jugular vein distension>6cm
- Tissue Doppler mitral annulus lateral>12 or medial>15
- Chest X-ray: pulmonary edema or pleural effusion
Who cannot join
- Need for inotropic or vasopressive agents
- Use of intravenous (IV) contrast media
- Acute coronary syndrome
- Need of dialysis
- Severe co-morbidity
- Contra-indications for anticoagulation
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The CRUF trial is a prospective randomized monocentric trial comparing different impact of diuretics versus ultrafiltration on renal congestion, plasma refill rate, echocardiographic filling pressures, neurohormonal activation and biomarkers of Acute Kidney Injury (AKI).
- Conditions
- Acute Decompensated Heart Failure
- Being tested
- ultrafiltration, diuretics
- Keywords
- Acute decompensated heart failure, ultrafiltration, diuretics, AKI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrafiltrationProcedure or surgery
Ultrafiltration through double lumen catheter, via central vein (Vena jugularis interna or Vena femoralis, 11 French, 15 cm for right jugular or 20 cm for femoralis and jugularis left-position). Based on severity of fluid overload the cardiologist determines the ultrafiltration rate. 'Multifiltrate Fresenius' (extracorporeal blood volume 72ml) in SCUF (slow continuous ultrafiltration) modus with pediatric lines (54 ml extracorporeal volume in the AV-set) and a pediatric filter (Ultraflux® AV paed, blood volume 18ml). Heparin to maintain an APTT between 65 en 85 seconds during ultrafiltration.
diureticsDrug
Bumetanide continuous infusion to reach a prescribed negative fluid balance: dose adjustment according to the diuretic response.
| Study group | Role | What they receive |
|---|---|---|
| ultrafiltration group | Active comparator | Not described Receives: Procedure: ultrafiltration |
| diuretics group | Active comparator | Not described Receives: Drug: diuretics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AKI and determining factors in patients with acute decompensated heart failure with treated with ultrafiltration versus diuretics
Measured: at 6 months
Secondary outcomes (3)
determination of the value of Neutrophil gelatinase-associated lipocalin (NGAL) to predict AKI in acute decompensated heart failure (vs creatinine, Cystatin C,measured urinary creatinine clearance) in patients treated with diuretics vs ultrafiltration.
Measured: at 48h after treatment start
Combined endpoint of mortality/rehospitalisation-urgent outpatient visit due to heart failure
Measured: at 6 months
Kidney function measured by creatinine
Measured: after 28 days and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startFeb 2010
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sofie Gevaert, MD, Principal investigator, University Hospital Ghent, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138683
- Sponsor's protocol ID
- 2009/539
- Other IDs
- 2009-017589-22, 2009
- Acronym
- CRUF
- Status last verified
- Jan 2012
- First submitted
- 4 Jun 2010
- Last updated
- 10 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiorenal Interactions During Treatment of Acute Decompensated Heart Failure: Diuretics Versus Ultrafiltration
- ClinicalTrials.gov ID
- NCT01138683
- Acronym / sponsor ID
- CRUF / 2009/539
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- Acute decompensated heart failure, ultrafiltration, diuretics, AKI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Jun 2010 (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.
The CRUF trial is a prospective randomized monocentric trial comparing different impact of diuretics versus ultrafiltration on renal congestion, plasma refill rate, echocardiographic filling pressures, neurohormonal activation and biomarkers of Acute Kidney Injury (AKI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrafiltration group | Active comparator | Procedure: ultrafiltration |
| diuretics group | Active comparator | Drug: diuretics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- >18 years old
- Severe systolic heart failure with ejection fraction <40%
- And Hospitalisation for decompensated heart failure
- And New York Heart Association (NYHA) III or IV
- And 1 of the following:
Key exclusion criteria (7 listed)
- Need for inotropic or vasopressive agents
- Use of intravenous (IV) contrast media
- Acute coronary syndrome
- Need of dialysis
- Severe co-morbidity
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 |
|---|---|---|
| ultrafiltrationUltrafiltration through double lumen catheter, via central vein (Vena jugularis interna or Vena femoralis, 11 French, 15 cm for right jugular or 20 cm for femoralis and jugularis left-position). Based on severity of fluid overload the cardiologist determines the ultrafiltration rate. 'Multifiltrate Fresenius' (extracorporeal blood volume 72ml) in SCUF (slow continuous ultrafiltration) modus with pediatric lines (54 ml extracorporeal volume in the AV-set) and a pediatric filter (Ultraflux® AV paed, blood volume 18ml). Heparin to maintain an APTT between 65 en 85 seconds during ultrafiltration. | Procedure or surgery | ultrafiltration group |
| diureticsBumetanide continuous infusion to reach a prescribed negative fluid balance: dose adjustment according to the diuretic response. | Drug | diuretics group |
Primary outcome
Incidence of AKI and determining factors in patients with acute decompensated heart failure with treated with ultrafiltration versus diuretics
Time frame: at 6 months
3 secondary outcomes
determination of the value of Neutrophil gelatinase-associated lipocalin (NGAL) to predict AKI in acute decompensated heart failure (vs creatinine, Cystatin C,measured urinary creatinine clearance) in patients treated with diuretics vs ultrafiltration.
Time frame: at 48h after treatment start
Combined endpoint of mortality/rehospitalisation-urgent outpatient visit due to heart failure
Time frame: at 6 months
Kidney function measured by creatinine
Time frame: after 28 days and 6 months
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 10 Jan 2012.
- website of University Hospital GhentLink provided by the sponsor.
Related trials for Acute Decompensated Heart Failure
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Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure
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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.
Sofie Gevaert, MD principal investigator
University Hospital Ghent, Belgium
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 ultrafiltration and diuretics in people with Acute Decompensated Heart Failure, run by University Hospital, Ghent at 1 site in Belgium.
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 7 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 10 Jan 2012. 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 Belgium. 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 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.
What does the primary outcome measure?
Incidence of AKI and determining factors in patients with acute decompensated heart failure with treated with ultrafiltration versus diuretics (time frame: at 6 months). It is what the study was designed to measure, not a finding.
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 10 Jan 2012.