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Non-invasive Evaluation of Fluid Status and Cardiac Output During Operative Treatment of Pheochromcytoma

Non-invasive Evaluation of Fluid Status and Cardiac Output During Operative Treatment of Pheochromcytoma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01425710
Enrollment
15
Registered
2011-08-30
Start date
2011-08-31
Completion date
2013-07-31
Last updated
2014-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pheochromocytoma

Keywords

Pheochromocytoma, Adrenalectomy, Cardiac output, Fluid managment, Esopagheal doppler sonography

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.

Interventions

None listed

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Arterial blood pressureparameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hourssystolic, diastolic, mean; continuous invasive measurement
Central venous pressureparameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hoursMeasured using esophageal doppler
Heart rateparameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
Cardiac output (CO)parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hoursmeasured using esophageal doppler
Systemic vascular resistance (SVR)parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hoursmeasured using esophageal doppler
Stroke volume (SV)parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hoursmeasured using esophageal doppler
Corrected aortic flow time(FTc)parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hoursmeasured using esophageal doppler

Secondary

MeasureTime frame
Changes in serum concentration: Norepinephrine7 timepoints during anesthesia (Administration of rocuronium, intubation, cut, intraabdominal air insufflation, ligature of v. suprarenalis, tumor exstirpation, end of operation)
Changes in serum concentration: Dopamin7 timepoints during anesthesia (Administration of rocuronium, intubation, cut, intraabdominal air insufflation, ligature of v. suprarenalis, tumor exstirpation, end of operation)
Changes in plasma concentration: Metanephrines7 timepoints during anesthesia (Administration of rocuronium, intubation, cut, intraabdominal air insufflation, ligature of v. suprarenalis, tumor exstirpation, end of operation)
Changes in serum Concentration: Epinephrine7 timepoints during anesthesia (Administration of rocuronium, intubation, cut, intraabdominal air insufflation, ligature of v. suprarenalis, tumor exstirpation, end of operation)

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026