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Completed

NCT Number: NCT01425710

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, 1050, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 30, 2011
Registry last updated
Feb 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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