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

• ClinicalTrials.gov Identifier: NCT01425710
• Recruitment Status: Completed
• First Posted: August 30, 2011
• Last Update Posted: February 13, 2014
• Sponsor: Medical University of Vienna
• Information provided by (Responsible Party): Martin Niederle, Medical University of Vienna

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
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: August 2011
• Actual Primary Completion Date: July 2013
• Actual Study Completion Date: July 2013

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Cardiac output (CO) [ Time Frame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours ]
   measured using esophageal doppler
2. Systemic vascular resistance (SVR) [ Time Frame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours ]
   measured using esophageal doppler
3. Stroke volume (SV) [ Time Frame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours ]
   measured using esophageal doppler
4. Corrected aortic flow time(FTc) [ Time Frame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours ]
   measured using esophageal doppler
5. Central venous pressure [ Time Frame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours ]
   Measured using esophageal doppler
6. Heart rate [ Time Frame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours ]
7. Arterial blood pressure [ Time Frame: 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 :

1. Changes in serum Concentration: Epinephrine [ Time Frame: 7 timepoints during anesthesia (Administration of rocuronium, intubation, cut, intraabdominal air insufflation, ligature of v. suprarenalis, tumor exstirpation, end of operation) ]
2. Changes in serum concentration: Norepinephrine [ Time Frame: 7 timepoints during anesthesia (Administration of rocuronium, intubation, cut, intraabdominal air insufflation, ligature of v. suprarenalis, tumor exstirpation, end of operation) ]
3. Changes in serum concentration: Dopamin [ Time Frame: 7 timepoints during anesthesia (Administration of rocuronium, intubation, cut, intraabdominal air insufflation, ligature of v. suprarenalis, tumor exstirpation, end of operation) ]
4. Changes in plasma concentration: Metanephrines [ Time Frame: 7 timepoints during anesthesia (Administration of rocuronium, intubation, cut, intraabdominal air insufflation, ligature of v. suprarenalis, tumor exstirpation, end of operation) ]

Biospecimen Retention:   Samples Without DNA

whole blood, serum

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

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

Austria

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Martin Niederle, MD, DMedSc, Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT01425710
• Other Study ID Numbers: pheo
• First Posted: August 30, 2011
• Last Update Posted: February 13, 2014
• Last Verified: February 2014

Keywords provided by Martin Niederle, Medical University of Vienna:

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

Additional relevant MeSH terms:

Pheochromocytoma; Paraganglioma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue