Non-invasive Evaluation of Fluid Status and Cardiac Output During Operative Treatment of Pheochromcytoma
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Purpose
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.
| Condition |
|---|
|
Pheochromocytoma |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Non-invasive Evaluation of Fluid Status and Cardiac Output During Operative Treatment of Pheochromcytoma |
- Cardiac output (CO) [ Time Frame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours ] [ Designated as safety issue: No ]measured using esophageal doppler
- Systemic vascular resistance (SVR) [ Time Frame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours ] [ Designated as safety issue: No ]measured using esophageal doppler
- Stroke volume (SV) [ Time Frame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours ] [ Designated as safety issue: No ]measured using esophageal doppler
- Corrected aortic flow time(FTc) [ Time Frame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours ] [ Designated as safety issue: No ]measured using esophageal doppler
- Central venous pressure [ Time Frame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours ] [ Designated as safety issue: No ]Measured using esophageal doppler
- Heart rate [ Time Frame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours ] [ Designated as safety issue: No ]
- Arterial blood pressure [ Time Frame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours ] [ Designated as safety issue: No ]systolic, diastolic, mean; continuous invasive measurement
- 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) ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
whole blood, serum
| Estimated Enrollment: | 15 |
| Study Start Date: | August 2011 |
| Groups/Cohorts |
|---|
|
Pheochromocytoma Group
Intraoperative esophageal doppler sonography during laparoscopic adrenalectomy performed for pheochromocytoma
|
|
Control group
Intraoperative esophageal doppler sonography during laparoscopic adrenalectomy for non-pheochromocytoma adrenal tumor
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients suffering from pheochromocytoma will be recruited by the Department of Surgery, Medical University of Vienna
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).
Contacts and Locations| Contact: Martin B Niederle, MD, DMedSc | 0043 1 40400 4102 | martin.niederle@meduniwien.ac.at |
| Austria | |
| Medical University of Vienna | Recruiting |
| Vienna, Austria, 1050 | |
| 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 |
More Information
No publications provided
| Responsible Party: | Martin Niederle, MD, DMedSc, Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT01425710 History of Changes |
| Other Study ID Numbers: | pheo |
| Study First Received: | August 24, 2011 |
| Last Updated: | August 27, 2011 |
| Health Authority: | Austria: Ethics committee, Med Uni Vienna |
Keywords provided by Medical University of Vienna:
|
Pheochromocytoma Adrenalectomy Cardiac output Fluid managment Esopagheal doppler sonography |
Additional relevant MeSH terms:
|
Pheochromocytoma Paraganglioma Neuroendocrine Tumors Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on May 22, 2013