Kidney Failure, AcutePhase 2NCT00122018
An Investigation of N-acetylcysteine and Fenoldopam as Renal Protection Agents for Cardiac Surgery
A Phase 2 study testing N-acetylcysteine and fenoldopam in people with Kidney Failure, Acute and Kidney Failure, Chronic, run by Linda F. Barr, M.D..
Trial summary
Patients with abnormal kidney function are at increased risk for complications following heart surgery, including worsening kidney function possibly requiring dialysis, a prolonged stay in the critical care unit and hospital, and the increased risk of death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Acute, Kidney Failure, Chronic, Cardiac Surgical Procedures
- What is being tested?
- N-acetylcysteine and fenoldopam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- May 2002to Mar 2006
- Phase
- Phase 2
- 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
- Chronic creatinine clearance </= 40cc/h
- Pre-operative cardiac surgery
Who cannot join
- Pre-operative ongoing dialysis
- Nausea and vomiting
- Uncontrolled glaucoma
- Allergy to metabisulfite
- Enrollment in another clinical study within 30 days
- Pregnancy
- Acute renal failure
About this study
Official title: N-acetylcysteine and Fenoldopam Protect the Renal Function of Patients With Chronic Renal Insufficiency Undergoing Cardiac Surgery.
Patients with abnormal kidney function are at increased risk for complications following heart surgery, including worsening kidney function possibly requiring dialysis, a prolonged stay in the critical care unit and hospital, and the increased risk of death. Prior attempts at kidney protection for heart surgery patients have had mixed results. Two medicines, fenoldopam and N-acetylcysteine, have been shown to protect kidney function in other circumstances that cause kidney stress. The purpose of this study is to determine whether these medications will help to maintain the function of diseased kidneys during heart surgery.
Read the detailed description
This is a randomized, double-blinded, placebo-controlled trial to evaluate fenoldopam and N-acetylcysteine (NAC) individually, and together, as renal protective agents for patients with renal insufficiency undergoing heart surgery. Subjects have chronic renal insufficiency with creatinine clearance (CrCl) </= 40cc/min but not on pre-operative dialysis, and receive: NAC 600 mg by mouth (po) twice a day (bid) or placebo starting 24 hours pre-operative and continuing through the day of surgery; and/or fenoldopam 0.1 mcg/kg/min intravenous (IV) or saline placebo at anesthetic induction and continuing for 48 hours. Outcome data include: nadir, post-operative day 3 and post-operative day 14 CrCl, time to CrCl nadir, length of Intensive Care Unit (ICU) stay, length of post-operative hospital stay, hospital costs, mortality, and the need for hemodialysis. Intraoperative and post-operative pressor use is being monitored. The enrollment will include 80 patients (20 in each group).
- Being tested
- N-acetylcysteine, fenoldopam
- Keywords
- Kidney failure, Cardiac Surgery, Fenoldopam, N-acetylcysteine
- Medical subject headings
- Acute Kidney Injury, Kidney Failure, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
Also called Mucomyst
fenoldopamDrug
Also called Corlopam
| Study group | Role | What they receive |
|---|---|---|
| NAC | Experimental | N-acetylcysteine started day prior to surgery, continued through night of surgery Receives: Drug: N-acetylcysteine |
| fenoldopam | Experimental | fenoldopam started at surgery continued for 24 hours Receives: Drug: fenoldopam |
| NAC and fenoldopam | Experimental | Both N-acetylcysteine and fenoldopam as above Receives: Drug: N-acetylcysteine; Drug: fenoldopam |
| Control | Placebo comparator | Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of post-operative hospital stay
Measured: 30-day
Length of post-operative critical care stay
Measured: 30-day
Creatinine clearance post-operative days 3, 14, and nadir
Measured: 14 day
Secondary outcomes (4)
Days to post-operative creatinine clearance nadir
Measured: 14 day
Intraoperative and post-operative pressor use (pressor-hours)
Measured: 48 hour
Hospital costs
Measured: 30-day
Mortality
Measured: 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startMay 2002
- Primary completionMar 2006
- Study completionMar 2006
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 Kidney Failure, AcuteStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Linda F. Barr, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor-investigator, Linda F. Barr, M.D., Pulmonary Critical Care Associates of Baltimore
- Investigators
- Linda F Barr, MD, Principal investigator, Pulmonary and Critical Care Assoc. of Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00122018
- Sponsor's protocol ID
- REPORT
- Status last verified
- Nov 2014
- First submitted
- 14 Jul 2005
- Last updated
- 7 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Barr LF, Kolodner K. N-acetylcysteine and fenoldopam protect the renal function of patients with chronic renal insufficiency undergoing cardiac surgery. Crit Care Med. 2008 May;36(5):1427-35. doi: 10.1097/CCM.0b013e31816f48ba.
PubMed 18434903Esezobor CI, Bhatt GC, Effa EE, Hodson EM. Fenoldopam for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD012905. doi: 10.1002/14651858.CD012905.pub2.
PubMed 39607014
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-acetylcysteine and Fenoldopam Protect the Renal Function of Patients With Chronic Renal Insufficiency Undergoing Cardiac Surgery.
- ClinicalTrials.gov ID
- NCT00122018
- Acronym / sponsor ID
- REPORT
- Keywords
- Kidney failure, Cardiac Surgery, Fenoldopam, N-acetylcysteine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Linda F. Barr, M.D.University, hospital or other
- Collaborators
- Abbott
- Study start
- May 2002
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 21 Jul 2005 (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 abnormal kidney function are at increased risk for complications following heart surgery, including worsening kidney function possibly requiring dialysis, a prolonged stay in the critical care unit and hospital, and the increased risk of death. Prior attempts at kidney protection for heart surgery patients have had mixed results. Two medicines, fenoldopam and N-acetylcysteine, have been shown to protect kidney function in other circumstances that cause kidney stress. The purpose of this study is to determine whether these medications will help to maintain the function of diseased kidneys during heart surgery.
Detailed description
This is a randomized, double-blinded, placebo-controlled trial to evaluate fenoldopam and N-acetylcysteine (NAC) individually, and together, as renal protective agents for patients with renal insufficiency undergoing heart surgery. Subjects have chronic renal insufficiency with creatinine clearance (CrCl) </= 40cc/min but not on pre-operative dialysis, and receive: NAC 600 mg by mouth (po) twice a day (bid) or placebo starting 24 hours pre-operative and continuing through the day of surgery; and/or fenoldopam 0.1 mcg/kg/min intravenous (IV) or saline placebo at anesthetic induction and continuing for 48 hours. Outcome data include: nadir, post-operative day 3 and post-operative day 14 CrCl, time to CrCl nadir, length of Intensive Care Unit (ICU) stay, length of post-operative hospital stay, hospital costs, mortality, and the need for hemodialysis. Intraoperative and post-operative pressor use is being monitored. The enrollment will include 80 patients (20 in each group).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NAC | Experimental | Drug: N-acetylcysteineN-acetylcysteine started day prior to surgery, continued through night of surgery |
| fenoldopam | Experimental | Drug: fenoldopamfenoldopam started at surgery continued for 24 hours |
| NAC and fenoldopam | Experimental | Drug: N-acetylcysteine, Drug: fenoldopamBoth N-acetylcysteine and fenoldopam as above |
| Control | Placebo comparator | –Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic creatinine clearance </= 40cc/h
- Pre-operative cardiac surgery
Key exclusion criteria (7 listed)
- Pre-operative ongoing dialysis
- Nausea and vomiting
- Uncontrolled glaucoma
- Allergy to metabisulfite
- Enrollment in another clinical study within 30 days
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 |
|---|---|---|
| N-acetylcysteineAlso: Mucomyst | Drug | NAC, NAC and fenoldopam |
| fenoldopamAlso: Corlopam | Drug | NAC and fenoldopam, fenoldopam |
Primary outcome
Length of post-operative hospital stay
Time frame: 30-day
Length of post-operative critical care stay
Time frame: 30-day
Creatinine clearance post-operative days 3, 14, and nadir
Time frame: 14 day
4 secondary outcomes
Days to post-operative creatinine clearance nadir
Time frame: 14 day
Intraoperative and post-operative pressor use (pressor-hours)
Time frame: 48 hour
Hospital costs
Time frame: 30-day
Mortality
Time frame: 30-day
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 7 Nov 2014.
- Results publication: PubMed 18434903Barr LF, Kolodner K. N-acetylcysteine and fenoldopam protect the renal function of patients with chronic renal insufficiency undergoing cardiac surgery. Crit Care Med. 2008 May;36(5):1427-35. doi: 10.1097/CCM.0b013e31816f48ba.
- Derived from this study: PubMed 39607014Esezobor CI, Bhatt GC, Effa EE, Hodson EM. Fenoldopam for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD012905. doi: 10.1002/14651858.CD012905.pub2.
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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.
Linda F Barr, MD principal investigator
Pulmonary and Critical Care Assoc. of Baltimore
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-acetylcysteine and fenoldopam in people with Kidney Failure, Acute and Kidney Failure, Chronic, run by Linda F. Barr, M.D..
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 2 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 7 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Length of post-operative hospital stay (time frame: 30-day). The study lists 3 primary outcomes in all. 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 NCT00122018, 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 7 Nov 2014.