A Randomized Effectiveness Trial of Early Hemodynamic Support in Patients Demonstrating a "Triple Low" of Mean-arterial Pressure, End-tidal Anesthetic Concentration, and Bispectral Index
This study is currently recruiting participants.
Verified September 2012 by Outcomes Research Consortium
Sponsor:
Outcomes Research Consortium
Information provided by (Responsible Party):
Daniel I. Sessler, M.D., Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00998894
First received: October 19, 2009
Last updated: September 7, 2012
Last verified: September 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | October 19, 2009 | ||||||||
| Last Updated Date | September 7, 2012 | ||||||||
| Start Date ICMJE | October 2009 | ||||||||
| Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
reaction time [ Time Frame: 90-day ] [ Designated as safety issue: No ] Alert will prompt staff to enact quicker hemodynamic support, thus reduction in mortality |
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| Original Primary Outcome Measures ICMJE |
The investigators propose to test the theory that early automatic identification of a "Triple Low" clinical condition and decision-support alerts will prompt earlier hemodynamic support and a consequent reduction in mortality. [ Time Frame: 90-day ] [ Designated as safety issue: No ] | ||||||||
| Change History | Complete list of historical versions of study NCT00998894 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Mean Arterial Pressure (MAP) [ Time Frame: intra-operative ] [ Designated as safety issue: No ] Alert will prompt staff to offer quicker hemodynamic support and increase of Mean Arterial Pressure (MAP). |
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| Original Secondary Outcome Measures ICMJE |
Early automatic identification of a "Triple Low" clinical condition and decision-support alerts will prompt earlier hemodynamic support and a consequent consequent increase in MAP. [ Time Frame: intra-operative ] [ Designated as safety issue: No ] | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A Randomized Effectiveness Trial of Early Hemodynamic Support in Patients Demonstrating a "Triple Low" of Mean-arterial Pressure, End-tidal Anesthetic Concentration, and Bispectral Index | ||||||||
| Official Title ICMJE | A Randomized Effectiveness Trial of Early Hemodynamic Support in Patients Demonstrating a "Triple Low" of Mean-arterial Pressure, End-tidal Anesthetic Concentration, and Bispectral Index | ||||||||
| Brief Summary | The investigators propose to test the theory that smart alarms for the Triple Low State incorporated into a decision support system built into an electronic anesthesia record will prompt clinicians to intervene earlier in situations that would otherwise provoke little concern, and that the alert system will reduce 90-day mortality. Specifically, the investigators will test the hypothesis that providing Triple Low alerts reduces 90-day mortality. Secondary outcomes will be the fraction of alerts that generate early clinician responses and the consequent increase in MAP. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | adults presenting for non-cardiac surgery under volatile general anesthesia |
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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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 9846 | ||||||||
| Estimated Completion Date | November 2013 | ||||||||
| Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00998894 | ||||||||
| Other Study ID Numbers ICMJE | 09-453 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Daniel I. Sessler, M.D., Outcomes Research Consortium | ||||||||
| Study Sponsor ICMJE | Outcomes Research Consortium | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Outcomes Research Consortium | ||||||||
| Verification Date | September 2012 | ||||||||
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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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