Trial Outcomes & Findings for Preoperative Alpha Blockade for Pheochromocytoma (NCT NCT03176693)
NCT ID: NCT03176693
Last Updated: 2023-11-20
Results Overview
Proportion of operative time outside target thresholds: SBP \>180 or \<80; DBP \> 90; MAP\>150 or \<50; HR\>90. Arterial line blood pressure measurements were extracted from the electronic medical record every 60 seconds.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
39 participants
Primary outcome timeframe
Intraoperative, approximately 90 minutes
Results posted on
2023-11-20
Participant Flow
19 patients pretreated with phenoxybenzamine included for analysis: 15 historical patients who were pre-treated with phenoxybenzamine by their provider, 4 prospective randomized patients. 20 patients pretreated with doxazosin included for analysis: 8 prospective randomized patients, 6 crossover patients (initially assigned phenoxybenzamine but elected to receive only doxazosin due to treatment cost), 6 prospective non-randomized patients
Participant milestones
| Measure |
Phenoxybenzamine
3-4 weeks prior to date of surgery, patient will start phenoxybenzamine 10mg PO twice daily. Phenoxybenzamine will then be titrated to a blood pressure \<120/80 (sitting) with mild orthostatic hypotension (drop in systolic blood pressure by 20 points or diastolic blood pressure by 10 points from sitting to standing position); systolic blood pressure not less than 90 (standing).
Phenoxybenzamine: Non-selective alpha blocker
|
Doxazosin
3-4 weeks prior to date of surgery, patient will start doxazosin 1 mg PO daily. Phenoxybenzamine will then be titrated to a blood pressure \<120/80 (sitting) with mild orthostatic hypotension (drop in systolic blood pressure by 20 points or diastolic blood pressure by 10 points from sitting to standing position); systolic blood pressure not less than 90 (standing).
Doxazosin: Selective alpha blocker
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
20
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preoperative Alpha Blockade for Pheochromocytoma
Baseline characteristics by cohort
| Measure |
Phenoxybenzamine
n=19 Participants
3-4 weeks prior to date of surgery, patient will start phenoxybenzamine 10mg PO twice daily. Phenoxybenzamine will then be titrated to a blood pressure \<120/80 (sitting) with mild orthostatic hypotension (drop in systolic blood pressure by 20 points or diastolic blood pressure by 10 points from sitting to standing position); systolic blood pressure not less than 90 (standing).
Phenoxybenzamine: Non-selective alpha blocker
|
Doxazosin
n=20 Participants
3-4 weeks prior to date of surgery, patient will start doxazosin 1 mg PO daily. Phenoxybenzamine will then be titrated to a blood pressure \<120/80 (sitting) with mild orthostatic hypotension (drop in systolic blood pressure by 20 points or diastolic blood pressure by 10 points from sitting to standing position); systolic blood pressure not less than 90 (standing).
Doxazosin: Selective alpha blocker
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
n=99 Participants
|
56 years
n=107 Participants
|
54 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other/unknown
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=99 Participants
|
20 participants
n=107 Participants
|
39 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Intraoperative, approximately 90 minutesProportion of operative time outside target thresholds: SBP \>180 or \<80; DBP \> 90; MAP\>150 or \<50; HR\>90. Arterial line blood pressure measurements were extracted from the electronic medical record every 60 seconds.
Outcome measures
| Measure |
Phenoxybenzamine
n=19 Participants
3-4 weeks prior to date of surgery, patient will start phenoxybenzamine 10mg PO twice daily. Phenoxybenzamine will then be titrated to a blood pressure \<120/80 (sitting) with mild orthostatic hypotension (drop in systolic blood pressure by 20 points or diastolic blood pressure by 10 points from sitting to standing position); systolic blood pressure not less than 90 (standing).
Phenoxybenzamine: Non-selective alpha blocker
|
Doxazosin
n=20 Participants
3-4 weeks prior to date of surgery, patient will start doxazosin 1 mg PO daily. Phenoxybenzamine will then be titrated to a blood pressure \<120/80 (sitting) with mild orthostatic hypotension (drop in systolic blood pressure by 20 points or diastolic blood pressure by 10 points from sitting to standing position); systolic blood pressure not less than 90 (standing).
Doxazosin: Selective alpha blocker
|
|---|---|---|
|
Hemodynamic Instability
|
14 percentage of total operative time
Interval 5.0 to 34.0
|
13 percentage of total operative time
Interval 3.0 to 33.0
|
SECONDARY outcome
Timeframe: 30 days postoperativelyDeath within 30 days of surgery
Outcome measures
| Measure |
Phenoxybenzamine
n=19 Participants
3-4 weeks prior to date of surgery, patient will start phenoxybenzamine 10mg PO twice daily. Phenoxybenzamine will then be titrated to a blood pressure \<120/80 (sitting) with mild orthostatic hypotension (drop in systolic blood pressure by 20 points or diastolic blood pressure by 10 points from sitting to standing position); systolic blood pressure not less than 90 (standing).
Phenoxybenzamine: Non-selective alpha blocker
|
Doxazosin
n=20 Participants
3-4 weeks prior to date of surgery, patient will start doxazosin 1 mg PO daily. Phenoxybenzamine will then be titrated to a blood pressure \<120/80 (sitting) with mild orthostatic hypotension (drop in systolic blood pressure by 20 points or diastolic blood pressure by 10 points from sitting to standing position); systolic blood pressure not less than 90 (standing).
Doxazosin: Selective alpha blocker
|
|---|---|---|
|
Mortality
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Preoperative (2-3 weeks prior to surgery)Outcome measures
| Measure |
Phenoxybenzamine
n=19 Participants
3-4 weeks prior to date of surgery, patient will start phenoxybenzamine 10mg PO twice daily. Phenoxybenzamine will then be titrated to a blood pressure \<120/80 (sitting) with mild orthostatic hypotension (drop in systolic blood pressure by 20 points or diastolic blood pressure by 10 points from sitting to standing position); systolic blood pressure not less than 90 (standing).
Phenoxybenzamine: Non-selective alpha blocker
|
Doxazosin
n=20 Participants
3-4 weeks prior to date of surgery, patient will start doxazosin 1 mg PO daily. Phenoxybenzamine will then be titrated to a blood pressure \<120/80 (sitting) with mild orthostatic hypotension (drop in systolic blood pressure by 20 points or diastolic blood pressure by 10 points from sitting to standing position); systolic blood pressure not less than 90 (standing).
Doxazosin: Selective alpha blocker
|
|---|---|---|
|
Daily Cost of Drug
|
442.20 Dollars
Interval 323.44 to 634.58
|
5.06 Dollars
Interval 1.88 to 8.92
|
SECONDARY outcome
Timeframe: From date of surgery (-2 to 3 weeks, -1 day, 30 days, 3 months, 6 months, 1 year)Population: Due to staff turnover and COVID-19 restrictions, data was not collected or analyzed.
Patients will take the SF-36 as well as a symptom survey describing the frequency and impact on their quality of life at several time points including prior to starting alpha blockade, immediately prior to surgery after being sufficiently blocked, and postoperatively at 30 days, 3 months, 6 months, and 1 year
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Postoperatively during inpatient stay and during readmissions up to 30 days postoperativelyMorbidity will be graded by Clavien Classification of adverse events
Outcome measures
| Measure |
Phenoxybenzamine
n=19 Participants
3-4 weeks prior to date of surgery, patient will start phenoxybenzamine 10mg PO twice daily. Phenoxybenzamine will then be titrated to a blood pressure \<120/80 (sitting) with mild orthostatic hypotension (drop in systolic blood pressure by 20 points or diastolic blood pressure by 10 points from sitting to standing position); systolic blood pressure not less than 90 (standing).
Phenoxybenzamine: Non-selective alpha blocker
|
Doxazosin
n=20 Participants
3-4 weeks prior to date of surgery, patient will start doxazosin 1 mg PO daily. Phenoxybenzamine will then be titrated to a blood pressure \<120/80 (sitting) with mild orthostatic hypotension (drop in systolic blood pressure by 20 points or diastolic blood pressure by 10 points from sitting to standing position); systolic blood pressure not less than 90 (standing).
Doxazosin: Selective alpha blocker
|
|---|---|---|
|
Morbidity as Assessed by Occurrence of Adverse Events
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: up to 30 days post-surgeryOutcome measures
| Measure |
Phenoxybenzamine
n=19 Participants
3-4 weeks prior to date of surgery, patient will start phenoxybenzamine 10mg PO twice daily. Phenoxybenzamine will then be titrated to a blood pressure \<120/80 (sitting) with mild orthostatic hypotension (drop in systolic blood pressure by 20 points or diastolic blood pressure by 10 points from sitting to standing position); systolic blood pressure not less than 90 (standing).
Phenoxybenzamine: Non-selective alpha blocker
|
Doxazosin
n=20 Participants
3-4 weeks prior to date of surgery, patient will start doxazosin 1 mg PO daily. Phenoxybenzamine will then be titrated to a blood pressure \<120/80 (sitting) with mild orthostatic hypotension (drop in systolic blood pressure by 20 points or diastolic blood pressure by 10 points from sitting to standing position); systolic blood pressure not less than 90 (standing).
Doxazosin: Selective alpha blocker
|
|---|---|---|
|
Participants Admitted to Post-operative Intensive Care Unit (ICU)
|
2 Participants
|
1 Participants
|
Adverse Events
Phenoxybenzamine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Doxazosin
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place