The effects of l-carnitine supplementation on inflammatory factors, oxidative stress, and clinical outcomes in patients with sepsis admitted to the intensive care unit (ICU): study protocol for a double blind, randomized, placebo-controlled clinical trial

Background: Sepsis is a common cause for admission to the intensive care unit (ICU), and its incidence has been increasing. It is associated with a significant increase in serum inflammatory biomarkers such as C-reactive protein (CRP) and cytokines such as interleukin 1 (IL-1), IL-6, and tumor necrosis factor (TNF). Sepsis is also associated with pathophysiological changes that include fluid accumulation in the lungs, eventually leading to acute respiratory distress syndrome (ARDS), tissue edema, hypotension, and acute kidney injury (AKI). Conventional therapies include antibiotics, but these may have important adverse effects, so novel therapeutic approaches are required. In animal studies, l-carnitine improves antioxidant status, and in some clinical trials, it has been shown to reduce inflammation. It has also been shown to improve respiratory distress and help maintain coenzyme A homeostasis, metabolic flexibility, promoting the normal function of the tricarboxylic acid (TCA) cycle, and oxidation of fatty acids by peroxisomes. We aim to determine the effects of very high doses of l-carnitine on inflammatory factors, oxidative stress, and clinical outcomes of patients with sepsis in ICU. Method and design: In this double-blind, randomized controlled clinical trial, we will use block randomization of 60 patients with sepsis, aged between 20 and 65 years from Al-Zahra Hospital, Isfahan, Iran. The intervention group (n = 30) will receive three capsules of l-carnitine (each capsule contains 1000 mg l-carnitine; totally 3000 mg/day) for 7 days, and a control group (n = 30) will receive a placebo with the same dose and for the same duration in addition to usual care. At baseline, scores for clinical and nutritional status (Acute Physiology and Chronic Health Evaluation II (APACHE II), Sequential Organ Failure Assessment (SOFA), Quick SOFA (qSOFA), and NUTRIC Score) will be assessed. At beginning and end point of the study, inflammatory markers (CRP, erythrocyte sedimentation rate (ESR)), oxidative stress status (total oxidative stress (TOS), total antioxidant capacity (TAC)), and clinical variables will be evaluated also. The mortality rate will be assessed within 28 days of the beginning of the intervention. Discussion: Because of the anti-inflammatory and antioxidant properties of l-carnitine, it is possible that using a high dose of 3000 mg daily of this nutritional supplement may reduce inflammation and oxidative stress and improve subsequent mortality of critically ill patients with sepsis. Trial registration: Iranian Registry of Clinical Trials IRCT20201129049534N1. Registered on 2 May 2021

Epidemiologic evaluation of tongue reactive lesions in the archives of Qazvin and Shahid Beheshti dental schools (1998-2014)

Background: Due to the situation and different functions of tongue, it is always expose to chronic stimulations, that’s why some kinds of lesion in tongue such as reactive lesions found in order to react these reactions. Objective: To determine the prevalence of reactive lesions in the archives of tongue reactive lesions in Tehran (Shahid Beheshti) and Qazvin dental faculties archive during the past 15 years. Methods: In this descriptive-sectional and retrospective study, all records related to tongue reactive lesions were investigated in pathology archive of Tehran (Shahid Beheshti) and Qazvin dental faculties in the period of 1998-2014. In each record, patient’s demographic characteristics (age and gender), lesion type (irritation fibroma (IF), Drug induced fibrous, Pyogenic granuloma (PG), and Hyperkeratosis), lesion location in tongue, patient habit and systematic diseases were recorded. Then data were analysed with Q-square, T-test and Anova test. Findings: The average age of investigated patients was 43±16 and 69/2% of patients were female. Generally from 70 recorded file Irritation fibroma (51/4%) had the most frequency. PG (38/6%) was respectively in second frequency rank. 42/9% tongue reactive lesion were located in lateral part, 28/6% in anterior part and then, in the ventral , dorsal and posterior of tongue. Reactive lesions such as PG had the most frequency in male, respectively, while in female reactive lesions such as IF had the most frequency respectively. Conclusion: IF, PG had the most frequency in compare to other reactive lesions in Tehran (Shahid Beheshti) and Qazvin dental faculties’ archive during the past 15 years, so Changes in life style and oral hygiene will help to prevent these damages

The effects of L-carnitine supplementation on inflammation, oxidative stress, and clinical outcomes in critically Ill patients with sepsis: a randomized, double-blind, controlled trial

Abstract Background Sepsis, a life-threatening organ dysfunction caused by a host’s dysregulated response to infection with an inflammatory process, becomes a real challenge for the healthcare systems. L-carnitine (LC) has antioxidant and anti-inflammatory properties as in previous studies. Thus, we aimed to determine the effects of LC on inflammation, oxidative stress, and clinical parameters in critically ill septic patients. Methods A randomized double-blinded controlled trial was conducted. A total of 60 patients were randomized to receive LC (3 g/day, n = 30) or placebo (n = 30) for 7 days. Inflammatory and oxidative stress parameters (C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), superoxide dismutase (SOD), malondialdehyde (MDA), total antioxidant capacity (TAC), 28-day mortality rate, and some monitoring variables were evaluated. Results There was no statistically significant difference between study arms in baseline characteristics and disease severity scores. CRP (p < 0.001) and ESR (p: 0.004) significantly reduced, and SOD (p < 0.001) and TAC (p < 0.001) significantly improved in the LC group after 7 days. Between-group analysis revealed a significant reduction in CRP (p: 0.001) and serum chloride (p: 0.032), an increase in serum albumin (p: 0.036) and platelet (p: 0.004) significantly, and an increase in SOD marginally (p: 0.073). The 28-day mortality rate was also lower in the LC group compared with placebo (7 persons vs. 15 persons) significantly (odds ratio: 0.233, p: 0.010). Conclusions L-carnitine ameliorated inflammation, enhanced antioxidant defense, reduced mortality, and improved some clinical outcomes in critically ill patients with sepsis. Trial registration IRCT20201129049534N1; May 2021