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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

May 8, 2008
August 1, 2012
May 2011
April 2012   (final data collection date for primary outcome measure)
TE echo LV 3-D volume changes. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00683007 on ClinicalTrials.gov Archive Site
APCO system changes. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Esophageal Echo Assessment of LV Function During Acute Normovolemic Hemodilution Using Crystalloid or Hypertonic Saline
Use of Transesophageal Echocardiography to Assess Left Ventricular Performance During Acute Normovolemic Hemodilution and Randomized Replacement With Intravenous Crystalloid or Hypertonic Saline

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).

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Hypovolemia
  • Other: Volume resuscitation (Crystalloid)
    Crystalloid vs. Hypertonic Saline Solution
  • Other: Volume resuscitation (Hypertonic Saline Solution)
    Crystalloid vs. Hypertonic Saline Solution
  • Active Comparator: 1
    Crystalloid
    Intervention: Other: Volume resuscitation (Crystalloid)
  • Active Comparator: 2
    Hypertonic Saline
    Intervention: Other: Volume resuscitation (Hypertonic Saline Solution)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
April 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Elective surgical patients requiring acute normovolemic hemodilution

Exclusion Criteria:

  • Contraindication for hemodilution
  • Contraindication for TE echo
Both
17 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00683007
232664, 200815960
No
Neal Fleming, MD, PhD, University of California, Davis
University of California, Davis
Not Provided
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
University of California, Davis
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP