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

Completed

• Conditions: Pheochromocytoma

• Registration Number: NCT01425710
• Lead Sponsor: Medical University of Vienna

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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-24
• Study First Submitted QC: 2011-08-27
• Study First Posted: 2011-08-30
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-12
• Last Update Posted: 2014-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stroke volume (SV)	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
Cardiac output (CO)	parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours	measured using esophageal doppler
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
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

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria