The effect of Curcumin Supplementation on Mortality Rate and Clinical Status of Traumatic ICU-Admitted Patients: A Study Protocol for a Randomized, Triple-Blind, Placebo-Controlled Clinical Trial

Background: Traumatic injuries significantly contribute to worldwide death and disability rates, often necessitating patient admission to the intensive care unit (ICU), and there is an increased risk of disabilities, poor clinical outcomes, and mortality. Suppressing inflammatory processes in these cases is associated with reduced mortality.Objectives: This research aims to evaluate the effectiveness of curcumin, a polyphenolic phytochemical known for its anti-inflammatory and various health benefits, in improving clinical outcomes and reducing mortality among ICU patients.Methods: The current study is a randomized, triple-blind, placebo-controlled trial in patients with traumatic injuries. This study will enroll ۳۲۷ patients admitted to the ICU for traumatic injury at Bahonar Hospital in Kerman, Iran. Participants will be randomly assigned in a ۱:۱:۱ ratio to one of three groups: (۱) high-dose curcumin, (۲) low-dose curcumin, and (۳) placebo. The first intervention group will receive two tablets, each containing ۵۰۰ mg of Curcumin and ۵ mg of Piperine. The second intervention group will receive one tablet with ۵۰۰ mg of Curcumin and ۵ mg of Piperine, along with one placebo tablet. The control group will receive two placebo tablets. All patients will receive their tablets once a day for ۷ days. The primary outcomes will be the ۸-day ICU mortality, ۳۰ days and ۶۰ days mortality rates, while secondary outcomes will include the Acute Physiology and Chronic Health Evaluation (APACHE II), Sequential Organ Failure Assessment (SOFA), Modified Nutrition Risk in Critically Ill (mNUTRIC) score, Glasgow Coma Scale (GCS), mortality rates at ۱۲۰- and ۱۸۰-days, duration of hospital/ICU stay, and laboratory results. All factors will be evaluated before and after interventions.Result: This article presents the protocol for an ongoing randomized controlled trial; therefore, no results are available yet.Conlusion: If this study's results indicate that curcumin supplementation effectively improves the outcomes of ICU patients with traumatic injuries, it could offer a cost-effective and readily available treatment to improve patient outcomes and reduce the burden of traumatic injuries on healthcare systems.

کلیدواژه ها:

curcumin ، Trauma ، ICU ، mortality ، inflammation ، phytomedicine