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Hydrogen - ClinicalTrials.gov

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Last Updated: 18 July 2022

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Short-Term Endogenous Hydrogen Sulfide Upregulation For Vein Graft Disease

Peripheral arterial disease remains a significant health problem in the United States, particularly with the metabolic syndrome and aging populations. Patients with advanced PAD can be viewed with surgical bypass using autogenous vein. Despite decades of vein graft research, our understanding of the vein graft failure mechanisms is vague. Our first pilot study had the aim to determine the safety and effectiveness of a PCR diet in vascular patients, but we found no significant adverse events in any of the patients receiving the diet. Patients don't like being forced to remain in the hospital research unit pre-operatively, according to the investigators. However, recent results in model organisms point to a rapid onset of PCR benefits and challenges the belief that long-term PCR is required for benefits to accrue. Both chronic and acute settings have been shown to reduce oxidative stress. Within our own human pilot study, vascular surgery patients have successfully completed 3 days of pre-operative PCR diet without experiencing adverse events or reactions. For the current study, the investigators recommend a randomised, controlled trial to determine patient satisfaction and biologic outcomes of a short-term PCR diet in comparison to a traditional ad libitum diet for 4 days prior to elective vascular surgery involving an open big surgery. This prospective, multi-year report of 226 vascular surgery patients undergoing non-emergency lower-extremity arterial vein bypass surgery randomized into two pre-operative diet groups: observational group and PCR. The Mifflin St. Jeor equation will be used to determine the 24-hour energy requirements for the PCR diet based on gender, age, height, weight, and activity factor. Daily physical fitness will be determined by questionnaire to determine the activity factor for accurate calorie restriction estimates. The entire course of the diet intervention will only be available for the first four days leading up to surgery. Subjects will be discretely randomized by the clinical research assistants after final clearance for their operation by the anesthesiology service, and their assigned group will be kept anonymous to all subsequent team members until data lock. This app helps the subject to upload a picture and a short description of their food from a mobile phone and then communicate the details with the study coordinator. Employees can do so with subjects in order to tell what exactly was eaten by the app.

Source link: https://clinicaltrials.gov/ct2/show/NCT05457881

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions