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| ID | Type | Description | Link |
|---|---|---|---|
| 200815960 | Other Identifier | UC Davis Instructional Review Goard |
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The purpose of this study is to examine how the heart functions when a calculated amount of blood is removed and how two fluids, Lactated Ringer's (considered the standard replacement fluid) and Hypertonic Saline, re-expand the vascular system.
This investigator-initiated, single-center, prospective, randomized, clinical experimental design will enroll 30 patients scheduled for elective radical prostatectomy, cystectomy, or cystoprostatectomy, and anterior/posterior spinal fusions, which includes routine acute normovolemic hemodilution (ANH) as a technique to decrease the need for banked blood transfusions. The purpose of this study is to compare two methods of volume replacement during the ANH procedure. Patients will be randomized to receive either standard crystalloid replacement with Lactated Ringers (LR) or 5% hypertonic saline. Selected measurements will be obtained by transesophageal echocardiography (TEE) for assessing changes in left ventricular volume and function associated with blood loss and replacement. This study will use the Accuson Cypress Cardiovascular System and the V5M transesophageal echocardiography probe (Siemens Medical Solutions, Malvern, PA). The TEE measurements will be recorded on magnetic optical discs and assessed off-line by the researcher after the data collection is completed using the proprietary software included in the ultrasound system. In addition, stroke volume variation measurement (SVV), Cardiac Output (CO), Cardiac Index (CI), and Stroke Volume Index (SVI) will be measured using the Vigileo (TM) arterial pressure monitor with the FloTrac (TM) sensor (Edwards Lifesciences, Irvine, CA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Crystalloid |
|
| 2 | Active Comparator | Hypertonic Saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volume resuscitation (Crystalloid) | Other | Crystalloid vs. Hypertonic Saline Solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| TE echo LV 3-D volume changes. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| APCO system changes. | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neal W. Fleming, M.D., Ph.D. | Director, Cardiovascular and Thoracic Anesthesiology, UC Davis, Department of Anesthesiology and Pain Medicine | Study Director |
| David D. Rose, PhD | Chief, Certified Registered Nurse Anesthetist, UC Davis, Department of Anesthesiology and Pain Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis Medical Center | Sacramento | California | 95758 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8053588 | Background | Cheung AT, Savino JS, Weiss SJ, Aukburg SJ, Berlin JA. Echocardiographic and hemodynamic indexes of left ventricular preload in patients with normal and abnormal ventricular function. Anesthesiology. 1994 Aug;81(2):376-87. doi: 10.1097/00000542-199408000-00016. | |
| 19923509 | Background | Kungys G, Rose DD, Fleming NW. Stroke volume variation during acute normovolemic hemodilution. Anesth Analg. 2009 Dec;109(6):1823-30. doi: 10.1213/ANE.0b013e3181ba41af. |
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| Volume resuscitation (Hypertonic Saline Solution) |
| Other |
Crystalloid vs. Hypertonic Saline Solution |
|
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D012462 | Saline Solution, Hypertonic |
| ID | Term |
|---|---|
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D006982 | Hypertonic Solutions |
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