Objectives Severe acute respiratory infection (SARI) caused by the SARS-CoV-2 virus may cause lung failure and the need for mechanical ventilation. Infection with SARS-COV-2 can lead to activation of inflammatory factors, increased reactive oxygen species, and cell damage. In addition to mucolytic effects, N-Acetylcysteine has antioxidant effects that we believe can help patients recover. In this study, we evaluate the efficacy of N-Acetylcysteine in patients with severe COVID-19. Trial design This is a prospective, randomized, single-blinded, phase 3 controlled clinical trial with two arms (ratio 1:1) parallel-group design of 40 patients, using the placebo in the control group. Participants All severe COVID-19 patients with at least one of the following five conditions: (respiration rate > 30 per minute), hypoxemia (O2 ≤ saturation, arterial oxygen partial pressure ratio <300), pulmonary infiltration (> 50% of lung area during 24 48 h), Lactate dehydrogenase (LDH) > 245 U / l, Progressive lymphopenia, and admitted to the intensive care unit of Shahid Mohammadi Hospital in Bandar Abbas and have positive PCR test results for SARS-Cov-2 and sign the written consent of the study will be included. Patients will be excluded from the study if they have a history of hypersensitivity to N-Acetylcysteine, pregnancy, or refuse to participate in the study. Intervention and comparator After randomization, participants in the intervention group receive standard of care (SOC) according to the National Committee of COVID-19 plus N-acetylcysteine (EXI-NACE 200mg/mL, in 10mL ampules of saline for parenteral injection (EXIR pharmaceutical company)) at a dose of 300 mg/kg equivalent to 20 gr as a slow single intravenous injection on the first day of hospitalization. In the control group patients receive SOC and placebo ( Sterile water for injection as the same dose). The placebo is identical in appearance to the N-acetylcysteine injection (EXIR pharmaceutical company as well). Main outcomes The primary endpoint for this study is a composite endpoint for the length of hospitalization in the intensive care unit and the patient's clinical condition. These outcomes were measured at the baseline (before the intervention) and on the 14th day after the intervention or on the discharge day. Randomisation Eligible participants (40) will be randomized in two arms in the ratio of 1: 1 (20 per arm) using online web-based tools and by permuted block randomization method. To ensure randomization concealment, random sequence codes are assigned to patients by the treatment team at the time of admission without knowing that each code is in the intervention or comparator group. Blinding (masking) All participants will be informed about participating in the study and the possible side effects of medication and placebo. Patients participating in the study will not be aware of the assignment to the intervention or control group. The principal investigator, health care personnel, data collectors, and those evaluating the outcome are aware of patient grouping. Numbers to be randomised (sample size) A total of 40 patients participate in this study, which are randomly divided; 20 patients in the intervention group will receive SOC and N-acetylcysteine, 20 patients in the control group will receive SOC and placebo. Trial status First version of the protocol was approved by the Deputy of Research and Technology and the ethics committee of Hormozgan University of Medical Sciences on February 14, 2021, with the local code 990573, and the recruitment started on March 2, 2021 and the expected recruitment end date is April 1, 2021. Trial registration The protocol was registered before starting participant recruitment entitled: Evaluation of the efficacy of N-Acetylcysteine in severe COVID-19 patients: a randomized controlled phase III clinical trial, IRCT20200509047364N3, at Iranian Registry of clinical trials on 20 February 2021. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).
Background A variety of health problems, such as metabolic syndrome (MetS), have been linked to sleep disorders. While numerous epidemiological studies have shown a U-shaped relationship between sleep duration and poor health outcomes, the results were limited and inconsistent. This study was designed to evaluate the relationship between sleep duration and MetS. Methods This population-based study was conducted on the participants aged 35–70 of Bandare-Kong Non-Communicable Diseases (BKNCD) Cohort Study, a part of Prospective Epidemiological Research Studies in IrAN (PERSIAN). MetS was diagnosed according to the National Cholesterol Education Program (NCEP) criteria and the Iranian-specific cut-off for waist circumference (≥ 95 cm). Sleep information was extracted through a standard questionnaire based on self-reported information. Data were analyzed by R software using generalized additive models (GAMs). A statistically significant level was considered as P < 0.05. Results A total of 3695 participants were included in the analyses. The mean age was 48.05 years (SD 9.36), and 2067 (55.9%) were female. The estimated Prevalence of MetS was 35.9%, and women appeared to be more likely to have MetS than men (P < 0.001). There was a non-linear and linear association between sleep duration and the risk of MetS in women and men, respectively. The lowest risk was observed among those with 7–7.5 h of sleep duration per night. Conclusion Long sleep duration was associated with increased risk of MetS and higher MetS severity score in both genders, while the short sleep duration increased the risk of Mets as well as MetS severity score just in women. The longitudinal studies would be suggested to assess the relationship between sleep quality and quantity components and MetS.
Introduction: Serum concentration of vitamin D is associated with the severity of liver disease, and, as the liver disease progresses, its level is reduced. Many studies have investigated serum levels of vitamin D in cholestatic liver diseases such as primary biliary cirrhosis and alcohol-related liver diseases. Data on the vitamin D level in patients with liver cirrhosis are inadequate. The general objective of this study was to determine serum vitamin D levels in patients with liver cirrhosis. Methods: In this cross-sectional study, cirrhosis diagnosis was conducted based on stable clinical and paraclinical symptoms, serological markers of hepatitis and liver enzymes, and liver biopsy on patient referred to Shahid Mohammadi Hospital in Bandar Abbas in 2015. The severity of cirrhosis in these patients was determined according to Child-Pugh (CHILD) classification and model for end-stage liver disease (MELD) score. Vitamin D lower than 50 nmol / L equal to 20ng / ml was considered as vitamin D deficiency; data were analyzed using the IBM SPSS 21.0 statistical software and using descriptive statistics, independent student t-test, chi-square, and Pearson test. Results: Seventy-eight patients (43.3%) were in the case group, and 102 cases (56.7%) were in the control group. The mean age of the patients participating in the study was 48.45 years. Among them, 124 patients (68.9%) were male and 56 (31.1%) were female. Hepatitis B and hepatitis C, each with 22 patients (28.9%), were the most common cause of cirrhosis in our patients. The mean duration of disease in patients participating in the study was 48.42 ± 12.31 months. The frequency of CHILD classes was, respectively, 32 patients (41%) in class A, 33 patients (42.3%) in class B, and 13 patients (16.7%) in class C. Vitamin D levels were significantly higher in the control group (P <0.001). There was an adverse relationship between the score on the Child-Pugh, MELD, and levels of vitamin D (P <0.001). Conclusion: Vitamin D levels were significantly lower in cirrhotic patients; further, if the severity of cirrhosis is higher, vitamin D levels are lower. According to our results, it is recommended to check the vitamin D levels in cirrhotic patients and treatment in vitamin D deficiency cases.
Aim: Due to the high prevalence of sickle cell anemia and beta-shaped sickle cell thalassemia in this region, we decided to conduct this study with the aim of investigating the status of pulmonary function in these patients in Bandar Abbas. Method: The statistical population in this study included all patients with sickle cell anemia and sickle cell beta-thalassemia who had referred to the hematology clinic from 2019-2020, which was equal to 60 people. Also, the workers who had referred to the specialized lung clinic for periodic health tests entered the study by observing the criteria for leaving the review as a control group. Participants were subjected to spirometry and pulmonary volumes were measured. Result: The patients in the case group, 39 (65%) were from sickle cell anemia, and 21 (35%) were from the sickle cell beta-thalassemia. In this study, all the studied parameters had a significant difference between the study group and the control, except for the mean age (p=0.906). In the control group, the values of FEV1 (Forced expiratory volume in 1 second), FVC (Forced vital capacity), and FEF25-75% (Forced expiratory flow 25-75%) are higher than these values in the case group, and this difference is significant (P <0.001). Conclusion: The results of the present study showed that the levels of FEV1, FVC and FEF 25-75% in the control group are higher than these values in the patient group and this difference is significant.
The novel coronavirus infection 2019 (COVID-19) is a pandemic viral disease officially named by World Health Organization (WHO) on March 11, 2020. It is mainly a respiratory disease but can involve other organs. Extrapulmonary presentations are broad and not well recognized. COVID-19 may trigger diabetic ketoacidosis (DKA) in a patient with adequately controlled diabetes. Pregnancy is an incomplete immune suppression status, making women more susceptible to infections, and the disease-related morbidity is higher during pregnancy. Herein, we present the case of a 23-year-old diabetic pregnant woman at 28 weeks gestation with acute pancreatitis, DKA, hypertriglyceridemia, with confirmed COVID-19 infection using polymerase change reaction (PCR). She underwent antiviral therapy, adequate intravenous hydration, insulin infusion, and plasmapheresis in the intensive care unit (ICU). Her condition ultimately improved. COVID-19 with simultaneous pregnancy and diabetes mellitus increases the risk of metabolic disorders. Therefore, rapid diagnosis and adequate management would be considered.
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