- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01425710
Non-invasive Evaluation of Fluid Status and Cardiac Output During Operative Treatment of Pheochromcytoma
Study Overview
Status
Conditions
Detailed Description
Pheochromocytomas and extraadrenal paragangliomas are catecholamin-producing tumours deriving from the adrenal medulla and sympathetic ganglia. The only causal therapy is surgical resection. Nowadays, laparoscopic adrenalectomy is thought to be the optimal approach. Chronic volume depletion due to chronic hypertension and preoperative α-adrenoreceptor-blockade (to avoid the effects of intraoperative catecholamine-excess) often lead to hypotension after resection of the tumour. Volume reload with high amounts of fluid is often needed. Therefor some authors recommended invasive measurement (pulmonary artery catheter) to control cardiac output parameters and fluid balance. However, there are non-invasive methods to measure cardiac output(CO), systemic vascular resistance(SVR), stroke volume(SV) and corrected aortic flow time(FTc) to estimate volume status. Except transesophageal echocardiography, other techniques such as transoesophageal doppler and pulse pressure methods exist but have not been investigated during surgical therapy for pheochromocytoma so far. The esophageal Doppler currently represents the "gold standard" for perioperative fluid replacement therapy.
The study's hypothesis is that non-invasive measurements of cardiac output (CO), systemic vascular resistance (SVR), corrected aortic flow time (FTc) and stroke volume (SV) are useful parameters during laparoscopic resection of pheochromocytoma (adrenalectomy) to document the intraoperative changes in volume status and to estimate the volume depletion.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Vienna, Austria, 1050
- Medical University of Vienna
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Planned laparoscopic adrenalectomy for pheochromocytoma (Biochemical confirmed adrenal and extraadrenal pheochromocytoma)
- Planned laparoscopic adrenalectomy for hormonally inactive adrenal tumor
Exclusion Criteria:
- Risk of esophageal bleeding or perforation exists (i.e., liver disease with portal hypertension and/or esophageal varicoses, other esophageal anomalies).
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Pheochromocytoma Group
Intraoperative esophageal doppler sonography during laparoscopic adrenalectomy performed for pheochromocytoma
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Control group
Intraoperative esophageal doppler sonography during laparoscopic adrenalectomy for non-pheochromocytoma adrenal tumor
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac output (CO)
Time Frame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
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measured using esophageal doppler
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parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
|
Systemic vascular resistance (SVR)
Time Frame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
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measured using esophageal doppler
|
parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
|
Stroke volume (SV)
Time Frame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
|
measured using esophageal doppler
|
parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
|
Corrected aortic flow time(FTc)
Time Frame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
|
measured using esophageal doppler
|
parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
|
Central venous pressure
Time Frame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
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Measured using esophageal doppler
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parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
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Heart rate
Time Frame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
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parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
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Arterial blood pressure
Time Frame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
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systolic, diastolic, mean; continuous invasive measurement
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parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Changes in serum Concentration: Epinephrine
Time Frame: 7 timepoints during anesthesia (Administration of rocuronium, intubation, cut, intraabdominal air insufflation, ligature of v. suprarenalis, tumor exstirpation, end of operation)
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7 timepoints during anesthesia (Administration of rocuronium, intubation, cut, intraabdominal air insufflation, ligature of v. suprarenalis, tumor exstirpation, end of operation)
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Changes in serum concentration: Norepinephrine
Time Frame: 7 timepoints during anesthesia (Administration of rocuronium, intubation, cut, intraabdominal air insufflation, ligature of v. suprarenalis, tumor exstirpation, end of operation)
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7 timepoints during anesthesia (Administration of rocuronium, intubation, cut, intraabdominal air insufflation, ligature of v. suprarenalis, tumor exstirpation, end of operation)
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Changes in serum concentration: Dopamin
Time Frame: 7 timepoints during anesthesia (Administration of rocuronium, intubation, cut, intraabdominal air insufflation, ligature of v. suprarenalis, tumor exstirpation, end of operation)
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7 timepoints during anesthesia (Administration of rocuronium, intubation, cut, intraabdominal air insufflation, ligature of v. suprarenalis, tumor exstirpation, end of operation)
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Changes in plasma concentration: Metanephrines
Time Frame: 7 timepoints during anesthesia (Administration of rocuronium, intubation, cut, intraabdominal air insufflation, ligature of v. suprarenalis, tumor exstirpation, end of operation)
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7 timepoints during anesthesia (Administration of rocuronium, intubation, cut, intraabdominal air insufflation, ligature of v. suprarenalis, tumor exstirpation, end of operation)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Martin B Niederle, MD, DMedSc, Medical University of Vienna
- Study Chair: Edith Fleischmann, Prof, MD, Medical University of Vienna
- Study Chair: Bruno Niederle, Prof, MD, Medical University of Vienna
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- pheo
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