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

Pheochromocytoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01425710
• Other study ID #: pheo
• Status: Completed
• Phase: N/A
• First received: August 24, 2011
• Last updated: February 12, 2014
• Start date: August 2011
• Est. completion date: July 2013

Study information

• Verified date: February 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethics committee, Med Uni Vienna
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pheochromocytoma

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac output (CO)	measured using esophageal doppler	parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours	No
Primary	Systemic vascular resistance (SVR)	measured using esophageal doppler	parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours	No
Primary	Stroke volume (SV)	measured using esophageal doppler	parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours	No
Primary	Corrected aortic flow time(FTc)	measured using esophageal doppler	parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours	No
Primary	Central venous pressure	Measured using esophageal doppler	parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours	No
Primary	Heart rate		parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours	No
Primary	Arterial blood pressure	systolic, diastolic, mean; continuous invasive measurement	parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours	No
Secondary	Changes in serum Concentration: Epinephrine		7 timepoints during anesthesia (Administration of rocuronium, intubation, cut, intraabdominal air insufflation, ligature of v. suprarenalis, tumor exstirpation, end of operation)	No
Secondary	Changes in serum concentration: Norepinephrine		7 timepoints during anesthesia (Administration of rocuronium, intubation, cut, intraabdominal air insufflation, ligature of v. suprarenalis, tumor exstirpation, end of operation)	No
Secondary	Changes in serum concentration: Dopamin		7 timepoints during anesthesia (Administration of rocuronium, intubation, cut, intraabdominal air insufflation, ligature of v. suprarenalis, tumor exstirpation, end of operation)	No
Secondary	Changes in plasma concentration: Metanephrines		7 timepoints during anesthesia (Administration of rocuronium, intubation, cut, intraabdominal air insufflation, ligature of v. suprarenalis, tumor exstirpation, end of operation)	No