Esophageal Echo Assessment of LV Function During Acute Normovolemic Hemodilution Using Crystalloid or Hypertonic Saline
Primary Purpose
Acute Hypovolemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Volume resuscitation (Crystalloid)
Volume resuscitation (Hypertonic Saline Solution)
Sponsored by
About this trial
This is an interventional treatment trial for Acute Hypovolemia focused on measuring TE echo, hemodilution, hypertonic, saline, Arterial Pressure Cardiac Output
Eligibility Criteria
Inclusion Criteria:
- Elective surgical patients requiring acute normovolemic hemodilution
Exclusion Criteria:
- Contraindication for hemodilution
- Contraindication for TE echo
Sites / Locations
- University of California Davis Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Crystalloid
Hypertonic Saline
Outcomes
Primary Outcome Measures
TE echo LV 3-D volume changes.
Secondary Outcome Measures
APCO system changes.
Full Information
NCT ID
NCT00683007
First Posted
May 8, 2008
Last Updated
May 24, 2017
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT00683007
Brief Title
Esophageal Echo Assessment of LV Function During Acute Normovolemic Hemodilution Using Crystalloid or Hypertonic Saline
Official Title
Use of Transesophageal Echocardiography to Assess Left Ventricular Performance During Acute Normovolemic Hemodilution and Randomized Replacement With Intravenous Crystalloid or Hypertonic Saline
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Hypovolemia
Keywords
TE echo, hemodilution, hypertonic, saline, Arterial Pressure Cardiac Output
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Crystalloid
Arm Title
2
Arm Type
Active Comparator
Arm Description
Hypertonic Saline
Intervention Type
Other
Intervention Name(s)
Volume resuscitation (Crystalloid)
Intervention Description
Crystalloid vs. Hypertonic Saline Solution
Intervention Type
Other
Intervention Name(s)
Volume resuscitation (Hypertonic Saline Solution)
Intervention Description
Crystalloid vs. Hypertonic Saline Solution
Primary Outcome Measure Information:
Title
TE echo LV 3-D volume changes.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
APCO system changes.
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elective surgical patients requiring acute normovolemic hemodilution
Exclusion Criteria:
Contraindication for hemodilution
Contraindication for TE echo
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal W. Fleming, M.D., Ph.D.
Organizational Affiliation
Director, Cardiovascular and Thoracic Anesthesiology, UC Davis, Department of Anesthesiology and Pain Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David D. Rose, PhD
Organizational Affiliation
Chief, Certified Registered Nurse Anesthetist, UC Davis, Department of Anesthesiology and Pain Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95758
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
8053588
Citation
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.
Results Reference
background
PubMed Identifier
19923509
Citation
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.
Results Reference
background
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Esophageal Echo Assessment of LV Function During Acute Normovolemic Hemodilution Using Crystalloid or Hypertonic Saline
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