Clinical trial NCT01425710: Non-invasive Evaluation of Fluid Status and Cardiac Output During Operative Treatment of Pheochromcytoma
Official title: Non-invasive Evaluation of Fluid Status and Cardiac Output During Operative Treatment of Pheochromcytoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pheochromocytoma
Keywords: Pheochromocytoma
Adrenalectomy
Cardiac output
Fluid managment
Esopagheal doppler sonography
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2011-08-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from pheochromocytoma will be recruited by the Department of Surgery, Medical University of Vienna

Brief summary: 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.

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 criteria: 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).

Primary outcomes:
measure: Cardiac output (CO)
timeFrame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
measure: Systemic vascular resistance (SVR)
timeFrame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
measure: Stroke volume (SV)
timeFrame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
measure: Corrected aortic flow time(FTc)
timeFrame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
measure: Central venous pressure
timeFrame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
measure: Heart rate
timeFrame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
measure: Arterial blood pressure
timeFrame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
Secondary outcomes:
measure: Changes in serum Concentration: Epinephrine
timeFrame: 7 timepoints during anesthesia (Administration of rocuronium, intubation, cut, intraabdominal air insufflation, ligature of v. suprarenalis, tumor exstirpation, end of operation)
measure: Changes in serum concentration: Norepinephrine
timeFrame: 7 timepoints during anesthesia (Administration of rocuronium, intubation, cut, intraabdominal air insufflation, ligature of v. suprarenalis, tumor exstirpation, end of operation)
measure: Changes in serum concentration: Dopamin
timeFrame: 7 timepoints during anesthesia (Administration of rocuronium, intubation, cut, intraabdominal air insufflation, ligature of v. suprarenalis, tumor exstirpation, end of operation)
measure: Changes in plasma concentration: Metanephrines
timeFrame: 7 timepoints during anesthesia (Administration of rocuronium, intubation, cut, intraabdominal air insufflation, ligature of v. suprarenalis, tumor exstirpation, end of operation)
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Martin B Niederle, MD, DMedSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Vienna
name: Edith Fleischmann, Prof, MD
role: STUDY_CHAIR
affiliation: Medical University of Vienna
name: Bruno Niederle, Prof, MD
role: STUDY_CHAIR
References:
citation: Niederle MB, Fleischmann E, Kabon B, Niederle B. The determination of real fluid requirements in laparoscopic resection of pheochromocytoma using minimally invasive hemodynamic monitoring: a prospectively designed trial. Surg Endosc. 2020 Jan;34(1):368-376. doi: 10.1007/s00464-019-06777-z. Epub 2019 Apr 11.