Ultrasound Measurement of Reactive Hyperemia in Critical Care (URHC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01726595|
Recruitment Status : Recruiting
First Posted : November 15, 2012
Last Update Posted : February 28, 2018
The investigators hypothesize that doctors and nurses can undergo a brief period of training and then use ultrasound to accurately measure blood flow in a forearm artery after a brief period when this flow is interrupted with a blood pressure cuff, a measurement the investigators call reactive hyperemia. Reactive hyperemia indicates whether the small blood vessels in the body are healthy -- lower reactive hyperemia indicates worse small blood vessel function. When measured by experienced ultrasound experts, low reactive hyperemia strongly predicts death in critically ill patients with infection (severe sepsis).
The investigators are conducting this study to determine if doctors and nurses, without specific pre-existing expertise in ultrasound, can be trained to make these measurements accurately. If so, the investigators will prove that these measurements can be applied reliably in real-world practice.
The investigators also hypothesize that reactive hyperemia predict the outcomes of illness not just in patients with severe infection, but in other critically ill patients as well.
Finally, the investigators hypothesize that reduced blood flow after blood pressure cuff occlusion is linked with other abnormalities of blood, previously identified in critically ill patients. For example, red blood cells from patients with severe sepsis have been shown to be stiffer than normal, so they are less able to flow along the small blood vessel passages of the body. Red blood cells become stiffer when there is a certain type of stress in the body known as "oxidative stress."
If the investigators show that low reactive hyperemia, stiff red blood cells, and oxidative stress are linked, the investigators hope to develop new treatments that reduce oxidative stress, reduce the stiffness of red blood cells, and in turn improve reactive hyperemia. Improvements in reactive hyperemia indicate improvements in small blood vessel function. Better small blood vessel function means better delivery of oxygen throughout the body. The investigators believe that this will improve outcomes for critically ill patients.
|Condition or disease|
|Severe Sepsis Critical Illness|
|Study Type :||Observational|
|Estimated Enrollment :||252 participants|
|Official Title:||Ultrasound Measurement of Reactive Hyperemia in Critical Care: Prognostic and Pathophysiologic Significance|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||July 2019|
Patients with severe sepsis or septic shock
non-infected critically ill
Patients with severe non-infectious systemic inflammatory response syndrome
- hospital mortality [ Time Frame: vital status at hospital discharge, an expected average of 3 weeks ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01726595
|Contact: Kathleen L. Falkner, R.N., B.S.N.||(585) 276-3144||Kathleen_Falkner@urmc.rochester.edu|
|United States, New York|
|University of Rochester Medical Center||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Kathleen L. Falkner, R.N., B.S.N. 585-276-3144 Kathleen_Falkner@urmc.rochester.edu|
|Sub-Investigator: Orren Wexler, M.D.|
|Sub-Investigator: Rodel Banal, M.D.|
|Principal Investigator:||Anthony P. Pietropaoli, M.D., M.P.H.||University of Rochester|