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Esophageal Echo Assessment of LV Function During Acute Normovolemic Hemodilution Using Crystalloid or Hypertonic Saline

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Neal Fleming, MD, PhD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00683007
First received: May 8, 2008
Last updated: August 1, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Hypovolemia
 Other: Volume resuscitation (Crystalloid)
Other: Volume resuscitation (Hypertonic Saline Solution)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Transesophageal Echocardiography to Assess Left Ventricular Performance During Acute Normovolemic Hemodilution and Randomized Replacement With Intravenous Crystalloid or Hypertonic Saline

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • TE echo LV 3-D volume changes. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • APCO system changes. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: May 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Crystalloid
 Other: Volume resuscitation (Crystalloid)
Crystalloid vs. Hypertonic Saline Solution
Active Comparator: 2
Hypertonic Saline
 Other: Volume resuscitation (Hypertonic Saline Solution)
Crystalloid vs. Hypertonic Saline Solution

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).

  Eligibility

Ages Eligible for Study:   17 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective surgical patients requiring acute normovolemic hemodilution

Exclusion Criteria:

  • Contraindication for hemodilution
  • Contraindication for TE echo
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00683007

Locations
United States, California
University of California Davis Medical Center
Sacramento, California, United States, 95758
Sponsors and Collaborators
University of California, Davis
Investigators
Study Director: Neal W. Fleming, M.D., Ph.D. Director, Cardiovascular and Thoracic Anesthesiology, UC Davis, Department of Anesthesiology and Pain Medicine
Principal Investigator: David D. Rose, PhD Chief, Certified Registered Nurse Anesthetist, UC Davis, Department of Anesthesiology and Pain Medicine
  More Information

Publications:

Responsible Party: Neal Fleming, MD, PhD, Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT00683007     History of Changes
Other Study ID Numbers: 232664, 200815960
Study First Received: May 8, 2008
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
TE echo
hemodilution
hypertonic
saline
Arterial Pressure Cardiac Output

Additional relevant MeSH terms:
Hypovolemia
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013