Trial · NCT01379898
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The main study parameter is defined as the percentage of intraoperative time that blood pressure is outside the predefined target range after pretreatment with either phenoxybenzamine or doxazosin. | Duration of surgery, i.e. on average 3 hours | Blood pressure and heart rate will be monitored continuesly during surgery. |
| Secondary | To attain preoperative blood pressure target values without co-medication | an expected average of 2 to 6 weeks before surgery | success rate of doxazosin and phenoxybenzamine to attain preoperative blood pressure target values without co-medication |
| Secondary | Resolution of (paroxysmal) symptoms and signs of pheochromocytoma. | an expected average of 2-6 weeks before surgery | Resulution of headache, palpitations, sweeting, paleness, nausea, flushes, fatigue and anxiety. |
| Secondary | Need for additional antihypertensive agents | an expected average of 2-6 weeks before surgery | Assessment of the number of patients who need additional antihypertensive drugs on top of the study drugs |
| Secondary | Adverse effects of study medication | an expected average of 2-6 weeks before surgery | Adverse effects of doxazosin or phenoxybenzamine |
| Secondary | Length of preoperative treatment in either outpatient or inpatient clinic. | an expected average of 2-6 weeks before surgery | Comparing duration of preoperative treatment in either outpatient or inpatient clinic |
| Secondary | Control of blood pressure and heart rate. | Duration of surgery, i.e. on average 3 hours | * number of episodes with systolic blood pressure (SBP) \> 160 mmHg * number of episodes with mean arterial blood pressure (MAP) \< 60 mmHg * duration (in minutes) of SBP \> 160 mmHg * duration (in minutes) of MAP \< 60 mmHg * number of episodes with heart rate \> 100/min * duration (in minutes) of heart rate \> 100/min * amount and type of vasoactive agents needed during surgery for adequate blood pressure control. * cumulative amount and type of intravenous fluids administered |
| Secondary | Length of hospital stay. | Participants will be followed for the duration of hospital stay an expected average of 2-5 weeks. | Number of days the patient is staying in the hospital before and after surgery |
| Secondary | Composite semi-quantitative score of intra- and postoperative hemodynamic control. | During surgery and the first 24 hours after surgery at the intensive/ medium care unit | Composite semi-quantitative score of intra- and postoperative hemodynamic control based on the following parameters: * blood pressure and heart rate outside target range * need for administration of vasoactive agents * need for administration of intravenous fluids |
| Secondary | Postoperative hypoglycaemia | First 24 hours postoperative | Frequency and severity (in mmol/L)of hypoglycaemia during first 24 hours after surgery. |
| Secondary | Perioperative mortality. | From first administration of study medication until 30 days after surgery. | Death from any cause occurring during period from first administration of study medication until 30 days after surgery. |
| Secondary | Perioperative cardiovascular morbidity. | From first administation of study medicaion until 30 days after surgery. | Cardiovascular events occurring during period from first administration of study medication until 30 days after surgery. Cardiovascular events are: myocardial infarction, cardiac arrhythmia requiring medical intervention, heart failure, cerebrovascular ischemia, cerebrovascular haemorrhage. |
| Secondary | Composite endpoint of perioperative mortality and perioperative cardiovascular morbidity. | From first administration of study medication until 30 days after surgery. | Death from any cause occurring or cardiovascular events occurring during period from first administration of study medication until 30 days after surgery. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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