PheochromocytomaNCT01425710
Non-invasive Evaluation of Fluid Status and Cardiac Output During Operative Treatment of Pheochromcytoma
An observational study of Pheochromocytoma, run by Medical University of Vienna at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pheochromocytoma
- How many people
- 15 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2011to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from pheochromocytoma will be recruited by the Department of Surgery, Medical University of Vienna
Who may be able to join
- Planned laparoscopic adrenalectomy for pheochromocytoma (Biochemical confirmed adrenal and extraadrenal pheochromocytoma)
- Planned laparoscopic adrenalectomy for hormonally inactive adrenal tumor
Who cannot join
- Risk of esophageal bleeding or perforation exists (i.e., liver disease with portal hypertension and/or esophageal varicoses, other esophageal anomalies).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pheochromocytoma
- Keywords
- Pheochromocytoma, Adrenalectomy, Cardiac output, Fluid managment, Esopagheal doppler sonography
- Medical subject headings
- Pheochromocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output (CO)
measured using esophageal doppler
Measured: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
Systemic vascular resistance (SVR)
measured using esophageal doppler
Measured: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
Stroke volume (SV)
measured using esophageal doppler
Measured: 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
Measured: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
Central venous pressure
Measured using esophageal doppler
Measured: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
Heart rate
Measured: 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
Measured: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
Secondary outcomes (4)
Changes in serum Concentration: Epinephrine
Measured: 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
Measured: 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
Measured: 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
Measured: 7 timepoints during anesthesia (Administration of rocuronium, intubation, cut, intraabdominal air insufflation, ligature of v. suprarenalis, tumor exstirpation, end of operation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PheochromocytomaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Niederle, Medical University of Vienna
- Investigators
- Martin B Niederle, MD, DMedSc, Principal investigator, Medical University of ViennaEdith Fleischmann, Prof, MD, Study chair, Medical University of ViennaBruno Niederle, Prof, MD, Study chair, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425710
- Sponsor's protocol ID
- pheo
- Status last verified
- Feb 2014
- First submitted
- 24 Aug 2011
- Last updated
- 13 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30976898
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Evaluation of Fluid Status and Cardiac Output During Operative Treatment of Pheochromcytoma
- ClinicalTrials.gov ID
- NCT01425710
- Acronym / sponsor ID
- pheo
- Conditions
- Pheochromocytoma
- Keywords
- Pheochromocytoma, Adrenalectomy, Cardiac output, Fluid managment, Esopagheal doppler sonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 30 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from pheochromocytoma will be recruited by the Department of Surgery, Medical University of Vienna
Key inclusion criteria (2 listed)
- Planned laparoscopic adrenalectomy for pheochromocytoma (Biochemical confirmed adrenal and extraadrenal pheochromocytoma)
- Planned laparoscopic adrenalectomy for hormonally inactive adrenal tumor
Key exclusion criteria (1 listed)
- Risk of esophageal bleeding or perforation exists (i.e., liver disease with portal hypertension and/or esophageal varicoses, other esophageal anomalies).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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
Heart rate
Time frame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours
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
4 secondary outcomes
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2014.
- Derived from this study: PubMed 30976898Niederle 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin B Niederle, MD, DMedSc principal investigator
Medical University of Vienna
Edith Fleischmann, Prof, MD study chair
Medical University of Vienna
Bruno Niederle, Prof, MD study chair
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pheochromocytoma, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output (CO) (time frame: parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01425710, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2014.