An Algorithm for Intra-operative Goal-directed Haemodynamic Management in Non-cardiac Surgery (ERAS_feasi)
| Tracking Information | |||||
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| First Received Date ICMJE | June 27, 2011 | ||||
| Last Updated Date | September 7, 2011 | ||||
| Start Date ICMJE | September 2007 | ||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
hospital length of stay [ Time Frame: a period of 60 days ] [ Designated as safety issue: No ] The perioperative hospital length of stay is assessed. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01384097 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | An Algorithm for Intra-operative Goal-directed Haemodynamic Management in Non-cardiac Surgery | ||||
| Official Title ICMJE | An Algorithm for Intra-operative Goal-directed Haemodynamic Management in Non-cardiac Surgery - a Feasibility Study | ||||
| Brief Summary | A systematic literature search a goal-directed haemodynamic algorithm was created. The hypothesis of this study was that the goal-directed haemodynamic algorithm is feasible and can improve clinical outcome. |
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| Detailed Description | After a systematic literature search a goal-directed haemodynamic algorithm was created. The algorithm was adapted to international standards and consensus was reached through a modified Delphi method at international meetings. The feasibility of using the algorithm for intraoperative haemodynamic management was tested and the resultant clinical data analyzed retrospectively for several types of surgery with the hypothesis that the goal-directed haemodynamic algorithm is feasible in the clinical setting and can improve clinical outcome. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients undergoing a surgical repair of hip fractures, open right hemicolectomy and extended hemicolectomy, radical tumor debulking in primary ovarian cancer or a pylorus-preserving pancreatic head resection. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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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 | Completed | ||||
| Enrollment ICMJE | 774 | ||||
| Completion Date | June 2011 | ||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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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 | NCT01384097 | ||||
| Other Study ID Numbers ICMJE | ERAS_feasibility | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Claudia Spies, Charite University, Berlin, Germany | ||||
| Study Sponsor ICMJE | Charite University, Berlin, Germany | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Charite University, Berlin, Germany | ||||
| Verification Date | September 2011 | ||||
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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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