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

NCT ID: NCT00683007

Last Updated: 2017-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-04-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Acute Hypovolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Crystalloid

Group Type ACTIVE_COMPARATOR

Volume resuscitation (Crystalloid)

Intervention Type OTHER

Crystalloid vs. Hypertonic Saline Solution

2

Hypertonic Saline

Group Type ACTIVE_COMPARATOR

Volume resuscitation (Hypertonic Saline Solution)

Intervention Type OTHER

Crystalloid vs. Hypertonic Saline Solution

Interventions

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Volume resuscitation (Crystalloid)

Crystalloid vs. Hypertonic Saline Solution

Intervention Type OTHER

Volume resuscitation (Hypertonic Saline Solution)

Crystalloid vs. Hypertonic Saline Solution

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Elective surgical patients requiring acute normovolemic hemodilution

Exclusion Criteria

* Contraindication for hemodilution
* Contraindication for TE echo
Minimum Eligible Age

17 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neal W. Fleming, M.D., Ph.D.

Role: STUDY_DIRECTOR

Director, Cardiovascular and Thoracic Anesthesiology, UC Davis, Department of Anesthesiology and Pain Medicine

David D. Rose, PhD

Role: PRINCIPAL_INVESTIGATOR

Chief, Certified Registered Nurse Anesthetist, UC Davis, Department of Anesthesiology and Pain Medicine

Locations

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University of California Davis Medical Center

Sacramento, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 8053588 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19923509 (View on PubMed)

Other Identifiers

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200815960

Identifier Type: OTHER

Identifier Source: secondary_id

232664

Identifier Type: -

Identifier Source: org_study_id

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