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

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT01425710

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pheochromocytoma

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.

Study Design

Study Type:

Observational

Actual Enrollment :

15 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Cardiac output (CO) [parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours]
measured using esophageal doppler
Systemic vascular resistance (SVR) [parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours]
measured using esophageal doppler
Stroke volume (SV) [parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours]
measured using esophageal doppler
Corrected aortic flow time(FTc) [parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours]
measured using esophageal doppler
Central venous pressure [parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours]
Measured using esophageal doppler
Heart rate [parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours]
Arterial blood pressure [parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours]
systolic, diastolic, mean; continuous invasive measurement

Secondary Outcome Measures

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)]
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)]
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)]
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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna	Vienna		Austria	1050

Sponsors and Collaborators

Medical University of Vienna

Investigators

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