Fluid OverloadPhase 3NCT01628731
Furosemide Versus Ethacrynic Acid in Children With Congenital Heart Disease
A Phase 3 study testing furosemide and ethacrynic acid in people with Fluid Overload, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
Trial summary
This study aims to verify if ethacrynic acid continuous infusion is superior to furosemide continuous infusion in total urine output production during the first 24 post operative hours. Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Fluid Overload
- What is being tested?
- furosemide and ethacrynic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2012to Nov 2013
- 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 Up to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with congenital heart disease undergoing cardiac surgery
- intraoperative aortic cross clamp over 90 minutes or interventional catheterization procedures with post-operative inotrope score over 20
- sign of fluid retention after surgical procedures
Who cannot join
- Preoperative renal dysfunction
- Preoperative administration of more than 4mg/kg/die loop diuretics
- Need for renal replacement therapy at ICU admission
- Need for ECMO at ICU admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Study of Furosemide Continuous Infusion Versus Ethacrynic Acid Continuous Infusion in Children Undergoing Cardiac Surgery: Randomized Double Blind Controlled Clinical Trial
This study aims to verify if ethacrynic acid continuous infusion is superior to furosemide continuous infusion in total urine output production during the first 24 post operative hours.
Read the detailed description
Diuretic therapy in children after open heart surgery is widely administered, though no evidence currently supports if an ideal drug or an ideal dosage can be recommended. Loop diuretics are the most effective drugs in terms of urine output production but may cause some collateral effects such as metabolic alkalosis, hypovolemia, hypokalemia, ototoxicity. Furthermore, some reports showed that loop diuretics usage can be associated with an increased risk of renal dysfunction and mortality. However, their use in children with signs of fluid overload, pulmonary edema or oliguria is mandatory and widely practiced.
Furosemide and ethacrynic acid are often prescribed and administered without any specific indication, basing on clinicians preferences.
No study so far, explored the hypothesis of which of these drugs is the most effective in terms of urine output production and safe in terms of renal function.
This study aims to verify if ethacrynic acid continuous infusion is superior to furosemide continuous infusion in total urine output production during the first 24 post operative hours.
- Conditions
- Fluid Overload
- Being tested
- furosemide, ethacrynic acid
- Keywords
- loop diuretics, fluid balance, urine output, acute renal dysfunction
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
furosemideDrug
Also called lasix
furosemide, intravenous, continuous infusion, 0.2 mg/kg/h for 24 hours
ethacrynic acidDrug
Also called reomax
ethacrynic acid, intravenous, continuous infusion, 0.2 mg/kg/h for 24 hours
| Study group | Role | What they receive |
|---|---|---|
| furosemide | Active comparator | furosemide, 0.2 mg/kg/h up to 0.8 mg/kg/h for 72 hours Receives: Drug: furosemide |
| ethacryinic acid | Active comparator | ethacrynic acid, 0.2 mg/kg/h up to 0.8 mg/kg/h for 72 hours Receives: Drug: ethacrynic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean total urine output production in the first post-operative day
Verification of the superiority of ethacrynic acid compared with furosemide in improving patients' total urine output by at least 1 ml/kg/h in the first 24 post-operative hours
Measured: first 24 hours after Intensive Care Unit admission
Secondary outcomes (1)
Mean creatinine and NGAL values
Verification of the superiority of ethacrynic acid compared with furosemide in improving patients' renal function (asessed as creatinine, NGAL and pRIFLE score) in the first 72 post-operative hours
Measured: first 72 hours after Intensive Care Unit admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fluid OverloadStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bambino Gesù Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zaccaria Ricci, Bambino Gesù Hospital and Research Institute
- Investigators
- Zaccaria Ricci, MD, Principal investigator, Bambino Gesù Hospital RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628731
- Sponsor's protocol ID
- FUROCRYNIC trial-1
- Other IDs
- OBG DIURETICS
- Status last verified
- Jul 2014
- First submitted
- 24 Jun 2012
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Klinge JM, Scharf J, Hofbeck M, Gerling S, Bonakdar S, Singer H. Intermittent administration of furosemide versus continuous infusion in the postoperative management of children following open heart surgery. Intensive Care Med. 1997 Jun;23(6):693-7. doi: 10.1007/s001340050395.
PubMed 9255651van der Vorst MM, Ruys-Dudok van Heel I, Kist-van Holthe JE, den Hartigh J, Schoemaker RC, Cohen AF, Burggraaf J. Continuous intravenous furosemide in haemodynamically unstable children after cardiac surgery. Intensive Care Med. 2001 Apr;27(4):711-5. doi: 10.1007/s001340000819.
PubMed 11398698Bagshaw SM, Gibney RT, McAlister FA, Bellomo R. The SPARK Study: a phase II randomized blinded controlled trial of the effect of furosemide in critically ill patients with early acute kidney injury. Trials. 2010 May 11;11:50. doi: 10.1186/1745-6215-11-50.
PubMed 20459801Ricci Z, Haiberger R, Pezzella C, Garisto C, Favia I, Cogo P. Furosemide versus ethacrynic acid in pediatric patients undergoing cardiac surgery: a randomized controlled trial. Crit Care. 2015 Jan 7;19(1):2. doi: 10.1186/s13054-014-0724-5.
PubMed 25563826
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Furosemide Continuous Infusion Versus Ethacrynic Acid Continuous Infusion in Children Undergoing Cardiac Surgery: Randomized Double Blind Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01628731
- Acronym / sponsor ID
- FUROCRYNIC trial-1
- Conditions
- Fluid Overload
- Keywords
- loop diuretics, fluid balance, urine output, acute renal dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Bambino Gesù Hospital and Research InstituteUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 27 Jun 2012 (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.
This study aims to verify if ethacrynic acid continuous infusion is superior to furosemide continuous infusion in total urine output production during the first 24 post operative hours.
Detailed description
Diuretic therapy in children after open heart surgery is widely administered, though no evidence currently supports if an ideal drug or an ideal dosage can be recommended. Loop diuretics are the most effective drugs in terms of urine output production but may cause some collateral effects such as metabolic alkalosis, hypovolemia, hypokalemia, ototoxicity. Furthermore, some reports showed that loop diuretics usage can be associated with an increased risk of renal dysfunction and mortality. However, their use in children with signs of fluid overload, pulmonary edema or oliguria is mandatory and widely practiced.
Furosemide and ethacrynic acid are often prescribed and administered without any specific indication, basing on clinicians preferences.
No study so far, explored the hypothesis of which of these drugs is the most effective in terms of urine output production and safe in terms of renal function.
This study aims to verify if ethacrynic acid continuous infusion is superior to furosemide continuous infusion in total urine output production during the first 24 post operative hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| furosemide | Active comparator | Drug: furosemidefurosemide, 0.2 mg/kg/h up to 0.8 mg/kg/h for 72 hours |
| ethacryinic acid | Active comparator | Drug: ethacrynic acidethacrynic acid, 0.2 mg/kg/h up to 0.8 mg/kg/h for 72 hours |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children with congenital heart disease undergoing cardiac surgery
- intraoperative aortic cross clamp over 90 minutes or interventional catheterization procedures with post-operative inotrope score over 20
- sign of fluid retention after surgical procedures
Key exclusion criteria (4 listed)
- Preoperative renal dysfunction
- Preoperative administration of more than 4mg/kg/die loop diuretics
- Need for renal replacement therapy at ICU admission
- Need for ECMO at ICU admission
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 |
|---|---|---|
| furosemideAlso: lasixfurosemide, intravenous, continuous infusion, 0.2 mg/kg/h for 24 hours | Drug | furosemide |
| ethacrynic acidAlso: reomaxethacrynic acid, intravenous, continuous infusion, 0.2 mg/kg/h for 24 hours | Drug | ethacryinic acid |
Primary outcome
Mean total urine output production in the first post-operative day
Time frame: first 24 hours after Intensive Care Unit admission
Verification of the superiority of ethacrynic acid compared with furosemide in improving patients' total urine output by at least 1 ml/kg/h in the first 24 post-operative hours
1 secondary outcome
Mean creatinine and NGAL values
Time frame: first 72 hours after Intensive Care Unit admission
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 24 Jul 2014.
- Background: PubMed 9255651Klinge JM, Scharf J, Hofbeck M, Gerling S, Bonakdar S, Singer H. Intermittent administration of furosemide versus continuous infusion in the postoperative management of children following open heart surgery. Intensive Care Med. 1997 Jun;23(6):693-7. doi: 10.1007/s001340050395.
- Background: PubMed 11398698van der Vorst MM, Ruys-Dudok van Heel I, Kist-van Holthe JE, den Hartigh J, Schoemaker RC, Cohen AF, Burggraaf J. Continuous intravenous furosemide in haemodynamically unstable children after cardiac surgery. Intensive Care Med. 2001 Apr;27(4):711-5. doi: 10.1007/s001340000819.
- Background: PubMed 20459801Bagshaw SM, Gibney RT, McAlister FA, Bellomo R. The SPARK Study: a phase II randomized blinded controlled trial of the effect of furosemide in critically ill patients with early acute kidney injury. Trials. 2010 May 11;11:50. doi: 10.1186/1745-6215-11-50.
- Derived from this study: PubMed 25563826Ricci Z, Haiberger R, Pezzella C, Garisto C, Favia I, Cogo P. Furosemide versus ethacrynic acid in pediatric patients undergoing cardiac surgery: a randomized controlled trial. Crit Care. 2015 Jan 7;19(1):2. doi: 10.1186/s13054-014-0724-5.
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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.
Zaccaria Ricci, MD principal investigator
Bambino Gesù Hospital RI
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 and ethacrynic acid in people with Fluid Overload, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
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 4 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 24 Jul 2014. 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 Italy. 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?
Mean total urine output production in the first post-operative day (time frame: first 24 hours after Intensive Care Unit admission). 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 NCT01628731, which also lists 4 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 24 Jul 2014.