Anesthesiology & Pain Medicine >> Research >> Focus Areas >> Pain Medicine & Neuroscience >> Open Label Study of the Safety and Efficacy of Conivaptan...
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Research Focus Areas:
Pain Medicine & Neuroscience

Open Label Study of the Safety and Efficacy of Conivaptan (Vaprisol) to Raise Serum Sodium Levels in Patients With Severe Traumatic Brain Injury

Principal Investigators

M. M. Treggiari, M.D., Ph.D., M.P.H., S. A. Deem, M.D., N.D. Yanez III, Ph.D.

Description

Traumatic brain injury (TBI) is a significant cause of morbidity and mortality in the United States. Annually, over 200,000 people are hospitalized and 50,000 die due to TBI. After the initial brain injury, additional injury (secondary injury) can occur due to brain swelling and an increase in the pressure inside the closed skull (high intracranial pressure). The use of fluids with high concentration of sodium (salt) is a common practice for severe TBI subjects because it causes water in the brain to shift from inside the brain cells to within blood vessels of the brain. This decreases brain swelling and, thereby, reduces intracranial pressure.

We hypothesize that increasing the sodium levels in the blood by removing water from the body instead of adding high quantities of salt might be better tolerated. We want to investigate if removing water from the body might allow achieving consistent, raised blood sodium levels, so that the benefits of high sodium blood levels can be achieved with fewer risks of side effects. We also hypothesize that consistently high sodium blood levels in the acute care setting will allow superior effects on the reduction of brain swelling. This approach might improve subject outcomes, while decreasing the potential for side effects related to hypertonic saline administration.

Conivaptan (Vaprisol®) is a drug used in patients with low serum sodium to promote water loss in the kidneys. This drug is FDA approved for the treatment of low blood sodium when the body's total fluid levels are normal or high. Conivaptan (Vaprisol®) has been demonstrated to increase sodium levels in a controlled fashion, while being well tolerated by a variety of subjects.

Our plan is to utilize conivaptan (Vaprisol®) to promote isolated water loss, in combination with normal (physiologic) fluid replacement to maintain a normal blood volume status.. The goal of this therapy is to raise blood sodium in a controlled fashion in subjects with severe TBI, and reduce the use of hypertonic saline infusion. We hypothesize that this therapy will maintain a stable state of high blood sodium, while decreasing the overall sodium load needed to achieve these goals.

Pain Medicine & Neuroscience:
Research Projects

An Internet CBT Intervention for Pediatric Chronic Pain and Disability
T. Palermo, Ph.D.
Cervical Sympathetic Block in Patients with Cerebral Vasospasm following Aneurysmal Subarachnoid Hemmorhage
M. DePinto, M.D., M.M. Treggiari, M.D., Ph.D., M.P.H.
Controlling Pain After Trauma
D. Patterson, Ph.D., S. R. Sharar, M.D., M. Jensen, Ph.D., H. Hoffman, Ph.D., et al.
Cytokine and Neurotransmitter Interactions in Sleep Regulation
M. R. Opp, Ph.D., L. Imeri, M.D.
Disability from Pediatric Traumatic Brain Injury
P Rivara, M.D., M. S. Vavilala, M.D.
Drug Interactions at the Human Blood-Brain Barrier
J. D. Unadkat, Ph.D., K. B. Domino, M.D., M.P.H., A. Collier, M.D., et al.
Effectiveness of Oxymorphone for Acute Postoperative Pain Pediatric Subjects
S.Bhananker, M.D.
Identifying Virtual Reality Analgesia Mechanisms by Pharmacologic Manipulation
S. R. Sharar, M. D., D.A. Patterson, Ph.D, H.Hunter, Ph.D., et al.
Influence of Dexmedetomidine on the Evoked Potentials During Spine Surgery
Rozet, M.D.
Innovations In Pediatric Pain Research
T. Palermo, Ph.D.
Ketorolac in Surgical Infants: Pharmacokinetics/Analgesia
A.M. Lynn, M.D.
Mechanism Of Action Of Volatile Anesthetics
P.G. Morgan, M.D.
Memantine for Post-Operative Pain Control in the Opiate-Tolerant Patient
G. Terman, M.D., Ph.D.
Modulation of Pruritus by Spinal Cannabinoids
G. W. Terman, M.D.,Ph.D.
Molecular Mechanisms of Sleep Responses to Viral Infection
James Krueger, PhD (WSU: PI); Mark R. Opp, PhD (co-investigator/subcontract PI)
Neonatal Pain, Depression and Pain Susceptibility at Maturity in Rats
Gayle Page, DNSc, RN (Johns Hopkins: PI); Mark R. Opp, PhD (co-investigator/subcontract PI)
Neurologic Injury after Non-Supine Surgery Registry
L. A. Lee, M.D., L. Stephens, Ph.D., K. B. Domino, M.D., M.P.H., K. L. Posner, Ph.D.
Neuron-glial communication and brain aging
Paula Bickford, PhD (University of South Florida: PI); Carmelina Gemma, PhD (co-investigator/subcontract PI)
Neuronal-Glial Dialogue and Cognition
Carmelina Gemma, PhD (PI)
Neurotoxic Effects of Volatile Anesthetics in C. Elegans
P.G. Morgan, M.D.
Open Label Study of the Safety and Efficacy of Conivaptan (Vaprisol) to raise serum sodium levels in patients with severe traumatic brain injury
M. M. Treggiari, M.D., Ph.D., M.P.H., S. A. Deem, M.D., N.D. Yanez III, Ph.D.
Optimizing the Control of Pain from Severe Burns
D. Patterson, Ph.D.; S R. Sharar, MD; D. Heimbach, MD., J Doctor, Ph.D.
Patient Perceptions of the Benefits of Long-Term Opioid Therapy (PLOT) Initiative-Beliefs and Behaviors
D. C. Turk, Ph.D., J. P. Robinson., M.D., R. Landau, M.D.
Sepsis Outcomes and Aging: Role of Sleep Disruption and the Blood Brain Barrier
Mark R. Opp, PhD (PI); William A. Banks, MD (co-investigator); Richard M. Raymond, PhD (co-investigator)
Shared Decision Making in Orthopaedic Spine Surgery to Improve Patient Safety
K. B. Domino,M.D, M.P.H.; K. L. Posner, Ph.D. et al.
Sleep-Wake Disturbances in Adolescents with Chronic Pain Research
T. Palermo, Ph.D.
Subgroups of FMS: Symptoms, Beliefs & Tailored Treatments
D.C. Turk, Ph.D., J. Robinson, M.D., Ph.D.
Subjective and Neuroimaging Assessment of Combined Opioid and Virtual Reality Analgesia
S. R. Sharar, M.D., T. Richards, Ph.D.
Ultrasound Guided Rectus Sheath Block for Post-Operative Pain Control Following Umbilical Hernia Repair
S. Flack, M.D.
University of Washington Urologic Chronic Pelvic Pain Syndromes Discovery Center
D. S. Buchwald, M.D., N. Jimenez, M. D., et al.
Web-based CBT for Opioid-treated Chronic Pain Patients With Aberrant Behavior
Rosenblum, Ph.D., D.C. Turk, Ph.D.