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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Martin Niederle, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01425710
First received: August 24, 2011
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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
Pheochromocytoma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Non-invasive Evaluation of Fluid Status and Cardiac Output During Operative Treatment of Pheochromcytoma

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Cardiac output (CO) [ Time Frame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours ] [ Designated as safety issue: No ]
    measured using esophageal doppler

  • Systemic vascular resistance (SVR) [ Time Frame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours ] [ Designated as safety issue: No ]
    measured using esophageal doppler

  • Stroke volume (SV) [ Time Frame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours ] [ Designated as safety issue: No ]
    measured using esophageal doppler

  • Corrected aortic flow time(FTc) [ Time Frame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours ] [ Designated as safety issue: No ]
    measured using esophageal doppler

  • Central venous pressure [ Time Frame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours ] [ Designated as safety issue: No ]
    Measured using esophageal doppler

  • Heart rate [ Time Frame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours ] [ Designated as safety issue: No ]
  • Arterial blood pressure [ Time Frame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours ] [ Designated as safety issue: No ]
    systolic, diastolic, mean; continuous invasive measurement


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

whole blood, serum


Enrollment: 15
Study Start Date: August 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01425710

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

No publications provided

Responsible Party: Martin Niederle, MD, DMedSc, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01425710     History of Changes
Other Study ID Numbers: pheo
Study First Received: August 24, 2011
Last Updated: February 12, 2014
Health Authority: Austria: Ethics committee, Med Uni Vienna

Keywords provided by 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

ClinicalTrials.gov processed this record on August 20, 2014