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

NCT01425710 | Completed

• 1 other identifier: pheo
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Pheochromocytoma

Keywords

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

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (4)

• 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)

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Planned laparoscopic adrenalectomy for pheochromocytoma (Biochemical confirmed adrenal and extraadrenal pheochromocytoma)
• Planned laparoscopic adrenalectomy for hormonally inactive adrenal tumor

You may not qualify if:

• Risk of esophageal bleeding or perforation exists (i.e., liver disease with portal hypertension and/or esophageal varicoses, other esophageal anomalies).

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1050, Austria

Location

Related Publications (1)

• 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.

  PMID: 30976898 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood, serum

MeSH Terms

Conditions

Pheochromocytoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Martin B Niederle, MD, DMedSc

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

• Edith Fleischmann, Prof, MD

  Medical University of Vienna

  STUDY CHAIR

• Bruno Niederle, Prof, MD

  Medical University of Vienna

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DMedSc

Study Record Dates

• First Submitted: August 24, 2011
• First Posted: August 30, 2011
• Study Start: August 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: February 13, 2014

Record last verified: 2014-02

Locations

AU (1)