Partial NephrectomyNCT00743106
The Effect of Fenoldopam in Solitary Partial Nephrectomy Surgery
A study testing Fenoldopam in people with Partial Nephrectomy, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This trial will study the effects of fenoldopam on renal function in patients who have a single kidney undergoing surgery to remove part of that kidney secondary to renal cell carcinoma. The investigators will monitor and evaluate throughout the perioperative course the kidney function. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Partial Nephrectomy
- What is being tested?
- Fenoldopam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Feb 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have a solitary kidney and present for a partial nephrectomy
- Patients who have one atrophic minimally functioning kidney and present for partial nephrectomy on the other kidney
Who cannot join
- History of current renal disease beyond the diagnosis of renal malignancy
- Insulin dependent diabetes mellitus, myocardial infarction without subsequent coronary artery bypass or angioplasty
- History of congestive heart failure, renovascular occlusion greater than 45 minutes or less than 15 minutes, greater than one half of the solitary kidney resected
- A major perioperative complication that would potentially affect postoperative renal function (myocardial infarction, congestive heart failure, pulmonary embolus, massive hemorrhage and hypotension, ureteral obstruction or vascular thrombosis), and evidence of nephrotoxicity due to antibiotics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Fenoldopam on Renal Function in Solitary Partial Nephrectomy Surgery
This trial will study the effects of fenoldopam on renal function in patients who have a single kidney undergoing surgery to remove part of that kidney secondary to renal cell carcinoma. The investigators will monitor and evaluate throughout the perioperative course the kidney function. Normally kidney function is predicted to show a worsening followed by an improvement after surgery.
The investigators want to specifically identify if the use of fenoldopam lessens the injury to the kidney with this surgery.
Read the detailed description
Prospective, randomized, blinded study-dividing patients into one of two groups: fenoldopam or placebo. The infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.Study time period will be approximately six weeks from the date of surgery. Specifically, the following pre- and post operative laboratory results will be recorded if available: . Basic metabolic panel - pre-op, post op days 1, 2, 3, 4, and 6 weeks
- Serum osmolality, urine osmolality, urine sodium - pre-op, post op days 1, 3
- Glomerular filtration rate - pre-op, post op days 1, 3, and 6 weeks
- Conditions
- Partial Nephrectomy
- Being tested
- Fenoldopam, Placebo
- Keywords
- nephrectomy, fenoldopam, atrophic minimally functioning kidney
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenoldopamDrug
Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours
PlaceboDrug
Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator | Placebo comparator | Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours Receives: Drug: Placebo |
| Fenoldopam Comparator | Active comparator | Fenoldopam (0.1 ~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours. Receives: Drug: Fenoldopam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular Filtration Rate (GFR) Percentage of Change From Baseline
Our intended primary analysis was to assess the effect of fenoldopam vs placebo on the GFR at post-operative day (POD) 3 with an analysis of covariance adjusting for the baseline GFR. However, because the intervention-by-baseline GFR interaction using GFR at POD 3 as the outcome was significant (P ¼ .006), the analysis of covariance was not valid. We, therefore, used the GFR percentage of change from baseline to POD 3 as the primary outcome.
Measured: percentage of change from baseline to post-operatively day 3
Secondary outcomes (1)
Postoperative Creatinine (mg/dL)
assessed the effect of fenoldopam on creatinine over time (immediately postoperatively and on postoperative day 1, 2, 3, 4)
Measured: "immediately postoperative, postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2008 (estimated)
- Study startSep 2002
- Primary completionFeb 2010
- Study completionFeb 2010
Why it stopped: Executive committee determined to close study after interim analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Partial NephrectomyStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jerome O'Hara, MD, Principal investigator, The Cleveland ClinicDaniel I Sessler, MD, Study chair, Cleveland Clnic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743106
- Sponsor's protocol ID
- 5508
- Status last verified
- Sep 2018
- First submitted
- 26 Aug 2008
- Last updated
- 19 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Esezobor 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 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fenoldopam on Renal Function in Solitary Partial Nephrectomy Surgery
- ClinicalTrials.gov ID
- NCT00743106
- Acronym / sponsor ID
- 5508
- Conditions
- Partial Nephrectomy
- Keywords
- nephrectomy, fenoldopam, atrophic minimally functioning kidney
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Executive committee determined to close study after interim analysis.
- Enrolment
- 90 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Sep 2002
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 28 Aug 2008 (estimated)
- Results
- Posted 31 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will study the effects of fenoldopam on renal function in patients who have a single kidney undergoing surgery to remove part of that kidney secondary to renal cell carcinoma. The investigators will monitor and evaluate throughout the perioperative course the kidney function. Normally kidney function is predicted to show a worsening followed by an improvement after surgery.
The investigators want to specifically identify if the use of fenoldopam lessens the injury to the kidney with this surgery.
Detailed description
Prospective, randomized, blinded study-dividing patients into one of two groups: fenoldopam or placebo. The infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.Study time period will be approximately six weeks from the date of surgery. Specifically, the following pre- and post operative laboratory results will be recorded if available: . Basic metabolic panel - pre-op, post op days 1, 2, 3, 4, and 6 weeks
- Serum osmolality, urine osmolality, urine sodium - pre-op, post op days 1, 3
- Glomerular filtration rate - pre-op, post op days 1, 3, and 6 weeks
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Comparator | Placebo comparator | Drug: PlaceboPlacebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours |
| Fenoldopam Comparator | Active comparator | Drug: FenoldopamFenoldopam (0.1 ~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who have a solitary kidney and present for a partial nephrectomy
- Patients who have one atrophic minimally functioning kidney and present for partial nephrectomy on the other kidney
Key exclusion criteria (4 listed)
- History of current renal disease beyond the diagnosis of renal malignancy
- Insulin dependent diabetes mellitus, myocardial infarction without subsequent coronary artery bypass or angioplasty
- History of congestive heart failure, renovascular occlusion greater than 45 minutes or less than 15 minutes, greater than one half of the solitary kidney resected
- A major perioperative complication that would potentially affect postoperative renal function (myocardial infarction, congestive heart failure, pulmonary embolus, massive hemorrhage and hypotension, ureteral obstruction or vascular thrombosis), and evidence of nephrotoxicity due to antibiotics
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 |
|---|---|---|
| FenoldopamFenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours | Drug | Fenoldopam Comparator |
| PlaceboPlacebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery | Drug | Placebo Comparator |
Primary outcome
Glomerular Filtration Rate (GFR) Percentage of Change From Baseline
Time frame: percentage of change from baseline to post-operatively day 3
Our intended primary analysis was to assess the effect of fenoldopam vs placebo on the GFR at post-operative day (POD) 3 with an analysis of covariance adjusting for the baseline GFR. However, because the intervention-by-baseline GFR interaction using GFR at POD 3 as the outcome was significant (P ¼ .006), the analysis of covariance was not valid. We, therefore, used the GFR percentage of change from baseline to POD 3 as the primary outcome.
1 secondary outcome
Postoperative Creatinine (mg/dL)
Time frame: "immediately postoperative, postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4"
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Related trials for Partial Nephrectomy
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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.
Jerome O'Hara, MD principal investigator
The Cleveland Clinic
Daniel I Sessler, MD study chair
Cleveland Clnic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fenoldopam in people with Partial Nephrectomy, run by The Cleveland Clinic at 1 site in United States.
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 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: stopped early, as of the sponsor's last update on 19 Sep 2018. 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 United States. 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. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Glomerular Filtration Rate (GFR) Percentage of Change From Baseline (time frame: percentage of change from baseline to post-operatively day 3). 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 NCT00743106, which also lists 1 linked publication.
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 Sep 2018.