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


N/A
18 Years
80 Years
Open (Enrolling)
Both
Pheochromocytoma

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Trial Information

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


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.


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).

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Cardiac output (CO)

Outcome Description:

measured using esophageal doppler

Outcome Time Frame:

parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours

Safety Issue:

No

Principal Investigator

Martin B Niederle, MD, DMedSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of Vienna

Authority:

Austria: Ethics committee, Med Uni Vienna

Study ID:

pheo

NCT ID:

NCT01425710

Start Date:

August 2011

Completion Date:

Related Keywords:

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

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