An interventional study of Volume resuscitation (Crystalloid) and Volume resuscitation (Hypertonic Saline Solution) in Acute Hypovolemia, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 17 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-05-30.
Sponsored by University of California, Davis · Not applicable, Interventional, and Treatment
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).
133 studies on the registry are indexed under Hypovolemia; 19 are open to participants now.
This study's enrollment of 9 is below the median of 43 across 66 interventional studies indexed under Hypovolemia.
Browse Hypovolemia studies →University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Crystalloid
Other: Volume resuscitation (Crystalloid)
Hypertonic Saline
Other: Volume resuscitation (Hypertonic Saline Solution)
Crystalloid vs. Hypertonic Saline Solution
Crystalloid vs. Hypertonic Saline Solution
TE echo LV 3-D volume changes.
Time frame: 1 hour
APCO system changes.
Time frame: 1 hour
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, Davis