Trial Outcomes & Findings for The Effect of Fenoldopam in Solitary Partial Nephrectomy Surgery (NCT NCT00743106)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

90 participants

Primary outcome timeframe

percentage of change from baseline to post-operatively day 3

Results posted on

2018-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours Placebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery	Fenoldopam 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. Fenoldopam: Fenoldopam (0.1 \~g/kg/min)started during surgery and lasting for a total of 24 hours
Overall Study STARTED	42	48
Overall Study COMPLETED	34	43
Overall Study NOT COMPLETED	8	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours Placebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery	Fenoldopam 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. Fenoldopam: Fenoldopam (0.1 \~g/kg/min)started during surgery and lasting for a total of 24 hours
Overall Study Met intraoperative exclusion criterion	8	5

Baseline Characteristics

The Effect of Fenoldopam in Solitary Partial Nephrectomy Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=34 Participants Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours Placebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery	Fenoldopam n=43 Participants 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. Fenoldopam: Fenoldopam (0.1 \~g/kg/min)started during surgery and lasting for a total of 24 hours	Total n=77 Participants Total of all reporting groups
Age, Continuous	59 years STANDARD_DEVIATION 9 • n=5 Participants	59 years STANDARD_DEVIATION 10 • n=7 Participants	59 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	33 Participants n=7 Participants	62 Participants n=5 Participants
Race/Ethnicity, Customized White	31 participants n=5 Participants	42 participants n=7 Participants	73 participants n=5 Participants
Race/Ethnicity, Customized Others	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants
GFR	59 mL/min STANDARD_DEVIATION 19 • n=5 Participants	59 mL/min STANDARD_DEVIATION 19 • n=7 Participants	59 mL/min STANDARD_DEVIATION 19 • n=5 Participants
creatinine	1.2 mg/dL n=5 Participants	1.2 mg/dL n=7 Participants	1.2 mg/dL n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=34 Participants Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours Placebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery	Fenoldopam n=43 Participants 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. Fenoldopam: Fenoldopam (0.1 \~g/kg/min)started during surgery and lasting for a total of 24 hours
Glomerular Filtration Rate (GFR) Percentage of Change From Baseline	-39 percentage change Standard Deviation 28	-28 percentage change Standard Deviation 38

SECONDARY outcome

Timeframe: "immediately postoperative, postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4"

assessed the effect of fenoldopam on creatinine over time (immediately postoperatively and on postoperative day 1, 2, 3, 4)

Outcome measures

Outcome measures
Measure	Placebo n=34 Participants Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours Placebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery	Fenoldopam n=43 Participants 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. Fenoldopam: Fenoldopam (0.1 \~g/kg/min)started during surgery and lasting for a total of 24 hours
Postoperative Creatinine (mg/dL) immediately postoperative	1.44 mg/dL Standard Error 0.07	1.37 mg/dL Standard Error 0.06
Postoperative Creatinine (mg/dL) postoperative day 1	2.14 mg/dL Standard Error 0.11	2.04 mg/dL Standard Error 0.12
Postoperative Creatinine (mg/dL) postoperative day 2	2.66 mg/dL Standard Error 0.23	2.38 mg/dL Standard Error 0.19
Postoperative Creatinine (mg/dL) postoperative day 3	2.65 mg/dL Standard Error 0.25	2.46 mg/dL Standard Error 0.25
Postoperative Creatinine (mg/dL) postoperative day 4	2.76 mg/dL Standard Error 0.30	2.61 mg/dL Standard Error 0.33

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fenoldopam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jerome O'Hara, MD

Cleveland Clinic Foundation

Phone: 216-444-8278

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place