Evaluation of Plasma Catecholamine Concentration During Surgery
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | July 28, 2009 | ||||
| Last Updated Date | July 28, 2009 | ||||
| Start Date ICMJE | June 2009 | ||||
| Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluation of Plasma Catecholamine Concentration During Surgery | ||||
| Official Title ICMJE | Evaluation of Stress Hormone Concentration During the Resection of Pheochromocytoma. Comparison of Surgeon - Anesthesiologist - Patient | ||||
| Brief Summary | Stress during surgery leads to significant increase in plasma catecholamine concentrations in surgeons, anesthesiologists, and patients. |
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| Detailed Description | Hypothesis: Resection of pheochromocytomas can lead to more than normal stress in surgeons and because of abrupt hemodynamic changes in patients as well in anesthesiologists. Measurements of catecholamine concentrations at baseline, prior to surgery during and after surgery, are to be performed to test this hypothesis. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Venous blood will be drawn from the surgeon, anesthesiologist and from 8 patients to determine plasma catecholamine concentrations. Only plasma will be used for measurements. |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | The population consists of 8 patients with pheochromocytoma scheduled for tumor resection, one surgeon (with the experience of more than 50 pheochromocytoma resections) and one anesthesiologist (with the experience of more than 50 pheochromocytoma resections). |
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| Condition ICMJE | Stress | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 8 | ||||
| Estimated Completion Date | September 2010 | ||||
| Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Patients with pheochromocytoma (Older than 18 years) - Exclusion Criteria: Patients younger than 18 years. Conservative treatment. - |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00948181 | ||||
| Other Study ID Numbers ICMJE | 2009061 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Prof. Dr. Harald Groeben, Kliniken Essen-Mitte | ||||
| Study Sponsor ICMJE | Kliniken Essen-Mitte | ||||
| Collaborators ICMJE | Universität Duisburg-Essen | ||||
| Investigators ICMJE |
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| Information Provided By | Kliniken Essen-Mitte | ||||
| Verification Date | July 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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