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Lack of consistent reference devices
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The purpose of this study is to retrospectively evaluate the hemodynamic response to goal directed fluid therapy fluid during open abdominal surgery where goal directed fluid therapy is a standard of care after establishing a pre-incision baseline response to fluids.
Electronic and annotated observation data to support an algorithm library
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initial bolus pre-incision | Other | Initial pre-incision bolus of 500 cc of fluids with hemodynamic response recorded |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Initial bolus pre-incision | Procedure | Measured hemodynamic response to pre-incision bolus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dynamic Hemodynamic Response to Fluid Resuscitation | Physiological parameters compared before and after fluid bolus for fluid resuscitation. | Up to 6 hours but not to exceed duration of surgical procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy E Miller, MB ChB, FRCA | DUHS Department of Anestheiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
Data collected for new algorithm development
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Patients meeting the inclusion and exclusion criteria were recruited in the pre-op clinic. Recruitment started on 15-AUG-2014 with ended in January 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Initial Bolus Pre-incision | Initial pre-incision bolus of 500 cc of fluids with hemodynamic response recorded Initial bolus pre-incision: Measured hemodynamic response to pre-incision bolus |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Self hemodynamic baseline before surgical incision.
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| ID | Title | Description |
|---|---|---|
| BG000 | Initial Bolus Pre-incision | Initial pre-incision bolus of 500 cc of fluids with hemodynamic response recorded Initial bolus pre-incision: Measured hemodynamic response to pre-incision bolus |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dynamic Hemodynamic Response to Fluid Resuscitation | Physiological parameters compared before and after fluid bolus for fluid resuscitation. | Reference devices were in disagreement so the algorithm could not be verified | Posted | Up to 6 hours but not to exceed duration of surgical procedure |
|
|
Two weeks. Consent in pre-op clinic to end of surgical procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-surgical Bolus | Pre-surgical bolus of 500 cc before incision rather than during incision for baseline hemodynamic data |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment | Hypertensive event during open abdominal procedure |
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Reference devices did not agree so trial terminated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timothy Miller MB ChB, FRCA | Duke University Medical Center, Department of Anesthesiology | (+1) 919 6819660 | timothy.miller2@duke.edu |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 2 |
| 18 |
| 0 |
| 18 |
|
| Blood Loss | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment | Excessive blood loss during the open abdominal procedure managed by fluid resuscitation |
|
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