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

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 Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1050
    • Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from pheochromocytoma will be recruited by the Department of Surgery, Medical University of Vienna

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac output (CO)	measured using esophageal doppler	parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
Systemic vascular resistance (SVR)	measured using esophageal doppler	parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
Stroke volume (SV)	measured using esophageal doppler	parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
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
Central venous pressure	Measured using esophageal doppler	parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
Heart rate		parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: August 24, 2011
• First Submitted That Met QC Criteria: August 27, 2011
• First Posted (Estimate): August 30, 2011

Study Record Updates

• Last Update Posted (Estimate): February 13, 2014
• Last Update Submitted That Met QC Criteria: February 12, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Cardiac output; Pheochromocytoma; Adrenalectomy; Fluid managment; Esopagheal doppler sonography
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Paraganglioma; Pheochromocytoma
• Other Study ID Numbers: pheo