Evaluation of the effect of Modafinil in the improvement of the level of consciousness in patients with COVID-19 encephalopathy: A randomized controlled trial.

AIM: COVID-19 can lead to encephalopathy and loss of consciousness. This double-blinded randomized clinical trial conducted in Tehran, Iran, aimed to assess the potential effectiveness of modafinil in patients with COVID-19-related encephalopathy. METHODS: Nineteen non-intubated COVID-19 patients with encephalopathy were randomized into two groups: a treatment group receiving crushed modafinil tablets and a placebo group receiving starch powder. Modafinil was administered at a dose of 100 mg every 2 h, reaching a peak dosage of 400 mg. The level of consciousness was assessed using the Glasgow Coma Score (GCS) at multiple time points on the day of medication administration. The trial was registered under IRCT20170903036041N3 on 23/5/2021. RESULTS: The average age in the modafinil and placebo groups was 75.33 and 70 years, respectively. No significant differences were observed between the two groups in terms of chronic conditions, clinical symptoms, or laboratory data. GCS scores were similar between the groups at baseline (p-value = 0.699). After four doses of modafinil, GCS scores were slightly higher in the treatment group, but this difference was not statistically significant (p-value = 0.581). GCS scores after each round of drug administration didn't significantly differ between the treatment and placebo groups (p-value = 0.908). CONCLUSION: Modafinil exhibited a slight improvement in the level of consciousness among COVID-19 patients with encephalopathy, although this improvement did not reach statistical significance when compared to the control group. Further research with larger sample sizes and longer treatment durations is recommended to explore modafinil's potential benefits in managing altered consciousness in COVID-19 patients.

Investigating Causes of Medical Errors in Intensive Care Units in Iran: A Cross-sectional Study.

Background: Medical errors cause disability and mortality in intensive care units (ICUs). We aimed to determine the occurrence and causes of medical errors in the ICUs of Iran. Methods: In this cross-sectional study, data from the family complaint files referred to The disciplinary authority of Iran Medical Council was retrospectively reviewed to explore the causes of medical errors. Statistical analysis was performed in SPSS Version 26.0. Results: A total of 293 complaint files were referred to the disciplinary commission from 2014 to 2019, of which 95 files were related to medical errors in ICUs. The median age of patients was 62 years (46-74 years) and 52 (54.7%) patients were men. Also, 37 (38.9%) patients had decreased levels of consciousness and 42 (42.2%) patients had cardiovascular disease. A total of 40 (42.1%) patients experienced a single medical error and 55 (57.9%) patients experienced more than 1. Causes of medical errors in patients were physician's or nurse's negligence in 53 (55.8%) patients, weak interaction of physician and nurse with the patient and family members in 11 (11.6%) patients, weak interprofessional interaction among physicians in 7 (7.4%) patients, equipment and structure of ICUs in 7 (7.4 patients, nature of ICUs and patients in 6 (6.3%) patients, weak physician-nurse interprofessional interaction in 5 (5.2%) patients) patients, low attention of the physician and the nurse to medication safety in 6 (6.3%) patients. Conclusion: Patient safety is impacted by a variety of medical mistakes. Interprofessional strategies can be developed and put into action to mitigate medical errors in ICUs.

Relationship between Mini Nutritional Assessment Score and Infection in Critical Care Patients.

Background: Nutrition and infectious diseases are 2 influential factors. Mini nutritional assessment (MNA) score is one of the indicators for assessing the nutritional status of the patients. The present study aimed to evaluate the relationship between MNA- short form (SF) and the infectious status of patients admitted to the intensive care unit (ICU) of Hazrat-e-Rasoul hospital in Tehran. Methods: This was a cross-sectional study performed at Hazrat-e-Rasoul hospital in Tehran from 2019 to 2020. Each patient completed the MNA-SF questionnaire. The questionnaire has 6 factors with a score range of 0 to 14, with 12 to 14 indicating "normal nutrition," 8 to 11 indicating "at risk of malnutrition," and 0 to 7 indicating "malnutrition." The patients were monitored for clinical and paraclinical signs and symptoms of infectious disease for the first 14 days after being admitted to the ICU. Then, the relationship between infection level and MNA-SF scores were recorded and the chi-square, independent samples t test, and Pearson correlation test were used. Results: In this study, 119 patients (60 men and 59 women), with a mean age of 53.82 ± 19.76 years were selected, and 71 (59.67%) of the patients had an infection. Women without infection were significantly more than men (p=0.021). In the assessment of the MNA-SF questionnaire, we found that 62 (52.1%) patients had "normal nutrition" status, 30 (25.2%), and 27 (22.7%) had "at risk for malnutrition" and "malnutrition" status, respectively. MNA-SF scores were significantly different in different age groups (p=0.040). There was a significant relationship between weight loss, mobility, and neuropsychological problems with age (p<0.001). Also, there was a meaningful relationship between nutritional status and infection (p=0.032). The results determined that noninfected cases among the patients with "normal nutrition" status were more than those "at risk for malnutrition" (p=0.007). The results of this study showed that clinical outcomes had a significant relationship with nutritional status (p=0.043). Conclusion: Based on the present study, good nutritional status can reduce infection and mortality in patients who are admitted to ICU, and the nutritional status assessed with MNA-SF can play an essential role in patients' susceptibility to infection.

Linear mixed model analysis to evaluate correlations between remdesivir adverse effects with age and gender of patients with mild Covid-19 pneumonia.

We aimed to assess longitudinal changes in clinical indexes of corona disease 2019 (Covid-19) patients with mild pulmonary infection during 5 days of remdesivir therapy and determine the effect of age and gender on remdesivir adverse effects (AE). Patients' clinical data including inflammatory markers, liver and renal function tests, and heart rate (HR) were extracted from medical records. Linear mixed model (LMM) was used to analyze longitudinal changes in patients' clinical indexes. Gender and age were inserted in LMM as covariates to find their correlation with AE and clinical indexes. Of 84 patients, 35 patients met our criteria for the study. There were significant increases in mean levels of white blood cell (WBC; p = 0.005), alanine aminotransferase (ALT; p = 0.001), aspartate aminotransferase (p = 0.001), blood urea nitrogen (BUN; p = 0.001), and creatinine (p = 0.006), whereas mean levels of erythrocyte sedimentation rate (p = 0.005), C-reactive protein (p = 0.001), alkaline phosphatase (p = 0.001), and potassium (p = 0.003) decreased significantly. Estimated glomerular filtration rate (p = 0.001) and HR (p = 0.001) showed a notable decline over the course of treatment. LMM analysis showed that mean changes in WBC (ß = 0.94, p = 0.029), creatinine (ß = 0.12, p = 0.020), and HR (ß = 6.47, p = 0.008) were greater in males than in females. Also, age of patients had a significant effect on the mean changes of WBC (ß = -0.02, p = 0.023), sodium (ß = -0.06, p = 0.010), BUN (ß = 0.23, p = 0.001), and HR (ß = -0.29, p = 0.001). Despite no renal and liver dysfunction, Covid-19 patients with mild pulmonary infection may develop some remdesivir AE and attributed side effects might be affected by gender and age of patients.

The outcome of using intravenous immunoglobulin (IVIG) in critically ill COVID-19 patients': a retrospective, multi-centric cohort study.

BACKGROUND: During the COVID-19 pandemic, different treatments have been used in critically ill patients. Using intravenous immunoglobulin (IVIG) has been suggested in various studies as an effective option. Our study aims to access the efficacy of IVIG in critically ill COVID-19 patients. METHODS: In this retrospective matched cohort study, records of three tertiary centers with a large number of COVID-19 admissions were evaluated and used. Based on treatment options, patients were divided into two groups, standard COVID-19 treatment (109 patients) and IVIG treatment (74 patients) patients. Also, the effect of IVIG in different dosages was evaluated. Patients with IVIG treatment were divided into three groups of low (0.25 gr/kg), medium (0.5 gr/kg), and high (1 gr/kg) dose. Data analysis was performed using an independent t test and one-way analysis of variance (ANOVA) to compare the outcomes between two groups, including duration of hospitalization, intensive care unit (ICU) length of stay, and mortality rate. RESULTS: The duration of hospitalization in the IVIG group was significantly longer than standard treatment (13.74 days vs. 11.10 days, p < 0.05). There was no significant difference between the two groups in ICU length of stay, the number of intubated patients, and duration of mechanical ventilation (p > 0.05). Also, initial outcomes in IVIG subgroups were compared separately with the standard treatment group. The results indicated that only the duration of hospitalization in the IVIG subgroup with medium dose is significantly longer than the standard treatment group (p < 0.01). CONCLUSION: Our data indicate that the use of IVIG in critically ill COVID-19 patients could not be beneficial, based on no remarkable differences in duration of hospitalization, ICU length of stay, duration of mechanical ventilation, and even mortality rate.

Effect of enteral immunomodulatory nutrition formula on mortality and critical care parameters in critically ill patients: A systematic review with meta-analysis.

BACKGROUND: Enteral immunomodulatory nutrition is recommended as an adjuvant therapy for patients in intensive care units (ICU), but its effectiveness is incompletely understood. AIM: The aim of this review was to examine the effect of a commonly used immunomodulatory formula-omega-3 fatty acids, γ-linolenic acid, and antioxidants-on clinical outcomes and mortality risk in critically ill patients. DESIGN: Systematic review and meta-analysis of randomized controlled trials (RCTs). METHOD: PubMed, Scopus, and Institute for Scientific Information (ISI) Web of Knowledge databases were searched until 18 February 2021. RCTs that used the immunomodulatory formula in the ICU were included. RESULTS: Ten RCTs (1166 participants) were included in the meta-analysis. The immunomodulatory formula reduced the duration of ICU stay weighted mean difference [(WMD): -2.97 days; 95%CI: -5.59, -0.35)], mechanical ventilation (WMD = -2.20 days, 95%CI: -4.29, -0.10), sequential organ failure assessment and multiple organ dysfunction scores (Hedge's g: -0.42 U/L; 95% CI: -0.74, -0.11), decreased 8-day overall mortality risk (RR = 0.74, 95% CI: 0.58, 0.91), and extended the ICU-free days (WMD: 4.06 days, 95% CI: 0.02, 8.09). The improvement in respiratory function and reduction in mortality risk was more in patients with acute lung injury (ALI) and acute respiratory distress syndrome (ARDS). Furthermore, the reduction in mechanical ventilation and mortality risk was more evident in older (>60 years) vs young adults. CONCLUSION AND RELEVANCE TO CLINICAL PRACTICE: Taken together, the immunomodulatory formula may enhance clinical practice for critical care nurses, such that the prevalence and/or susceptibility to secondary conditions commonly encountered in the ICU (ie, ALI and ARDS) could be attenuated, ultimately allowing critical care nurses to focus their care on the primary reason for which a patient is in the ICU. The study protocol was registered in PROSPERO.

The effect of French maritime pine bark extract supplementation on inflammation, nutritional and clinical status in critically ill patients with traumatic brain injury: A randomized controlled trial.

Inflammation plays an important role in the pathophysiology of traumatic brain injury (TBI). Based on the anti-inflammatory properties of French maritime pine bark extract and the neuroprotective effects, we aimed to evaluate the effects of its supplementation on TBI. Sixty-seven TBI patients admitted to the intensive care units (ICUs) were enrolled. After stabilizing the hemodynamic status, the intervention group received 150 mg of French maritime pine bark extract supplementation (Oligopin) with enteral nutrition for 10 days. The control group received a placebo. Inflammatory status and oxidative stress markers were measured three times. Also, clinical and nutritional statuses were assessed. Supplementation, significantly decreased IL-6 (ß = -53.43 pg/ml, 95% confidence interval [CI] = -91.74, -15.13, p = .006), IL-1ß (ß = -111.66 pg/ml, 95% CI = -183.79, -39.5402, p = .002) and C-reactive protein (ß = -19.99 mg/L, 95% CI = -27.23, -12.76, p Ëƒ .001) in the intervention group compared to control group after 10 days. Clinical scores including acute physiology and chronic health evaluation II and sequential organ failure assessment were reduced (ß = -3.72, 95% CI = -5.96, -1.49, p = .001and ß = -2.07, 95% CI = -3.23, -0.90, p < .001, respectively), and Nutric score was reduced compared to control group (ß = -.60, 95% CI = -1.08, -0.12, p = .01). The survival rate was higher by 15% in the intervention group compared to control group. Oligopin supplementation in TBI patients in ICU reduced inflammation and improved the clinical status and malnutrition score and thereby reducing the mortality rate.

Effect of bariatric surgery on endogenous sex hormones and sex hormone-binding globulin levels: a systematic review and meta-analysis.

BACKGROUND: Most studies have shown beneficial effect of bariatric surgery (BS) on serum levels of sex hormones. OBJECTIVE: A systematic review and meta-analysis was conducted to examine the magnitude of possible changes in levels of sex hormones following BS. SETTINGS: Electronic databases were searched, including PubMed, Scopus, Web of Science, and Embase, for relevant studies. METHODS: The heterogeneity of the studies was examined by χ2 tests and the degree of heterogeneity was estimated using I2 statistic. RESULTS: The results of pooled analyses revealed that BS caused a significant increase in luteinizing hormone (LH), follicular stimulating hormone (FSH), total testosterone (TT), and sex hormone binding globulin (SHBG) levels and conversely, decreased dehydroepiandrosterone (DHEA) and estradiol (E2) levels in males. For females, BS significantly increased LH, FSH, and SHBG levels and conversely, decreased androstenedione (AE), E2 and TT levels. Additionally, the level of progesterone (P), prolactin (PRL), free testosterone (FT) and dehydroepiandrosterone sulfate (DHEA-S) showed no significant changes in patients who had undergone BS. CONCLUSION: BS changed most sex hormones levels including LH, FSH, TT, SHBG, AE, DHEA, and E2. It seems that BS is able to exert substantial impacts on sex hormones levels and as well as sexual function, however, larger, and more precise trials are required to specifically focus on these claims.

Nutritional adequacy in critically ill patients: Result of PNSI study.

BACKGROUND & AIMS: Critically ill patients are provided with the intensive care medicine to prevent further complications, including malnutrition, disease progression, and even death. This study was intended to assess nutritional support and its' efficacy in the Intensive Care Units (ICUs) of Iran. METHODS: This cross-sectional study assessed 50 ICU's patients out of 25 hospitals in the 10 major regions of Iran's health system and was performed using the multistage cluster sampling design. The data were collected from patient's medical records, ICU nursing sheets, patients or their relatives from 2017 to 2018. Nutritional status was investigated by modified NUTRIC score and food frequency checklist. RESULTS: This study included 1321 ICU patients with the mean age of 54.8 ± 19.97 years, mean mNUTRIC score of 3.4 ± 2.14, and malnutrition rate of 32.6%. The mean time of first feeding was the second day and most of patients (66%) received nutrition support, mainly through enteral (57.2%) or oral (37%) route during ICU stay. The patients received 59.2 ± 37.78 percent of required calorie and 55.5 ± 30.04 percent of required protein. Adequate intake of energy and protein was provided for 16.2% and 10.7% of the patients, respectively. The result of regression analysis showed that the odds ratio of mNUTRIC score was 0.85 (95% confidence interval [CI] = 0.74-0.98) and APACHE II was 0.92 (95%CI = 0.89-0.95) for the prediction of energy deficiency. Nutrition intake was significantly different from patient's nutritional requirements both in terms of energy (p < 0.001) and protein (p < 0.001). Also, mean mNUTRIC score varied notably (p = 0.011) with changing in energy intake, defined as underfeeding, adequate feeding, and overfeeding. CONCLUSION: The present findings shown that, provided nutritional care for ICU patients is not adequate for their requirements and nutritional status.

Effect of evening primrose oil supplementation on lipid profile: A systematic review and meta-analysis of randomized clinical trials.

BACKGROUND: Studies have shown that evening primrose oil (EPO) supplementation might be effective in improving lipid profile, however, the results are inconsistent. This study was performed to determine the direction and magnitude of the EPO effect on the lipid profile. METHODS: PubMed, Scopus, Cochrane Library, Embase and Web of Science databases and Google Scholar were searched up to September-2019. Meta-analysis was performed using the random-effects model. Lipid profile including high-density lipoprotein (HDL), total cholesterol (TC), triglyceride (TG), and low-density lipoprotein (LDL) was considered as the primary outcome. RESULTS: A total of 926 articles were identified through database searching, of which, six RCTs were included in the meta-analysis. There were six studies on HDL, TC, and TG and four studies on LDL. EPO supplementation had no significant effect on TC, TG, LDL, and HDL. However, in subgroup analysis, a significant reduction in TG at a dose of ≤4 g/day (weighted mean difference [WMD] = -37.28 mg/dl; 95% CI: -73.53 to -1.03, p = .044) and a significant increase in HDL in hyperlipidemic subjects (WMD = 5.468 mg/dl; 95% CI: 1.323 to 9.614, p = .010) was found. CONCLUSION: Oral intake of EPO at a dose of ≤4 g/day significantly reduces serum TG levels and significantly increases HDL levels in hyperlipidemic subjects.

Evaluation of the effects of pycnogenol (French maritime pine bark extract) supplementation on inflammatory biomarkers and nutritional and clinical status in traumatic brain injury patients in an intensive care unit: A randomized clinical trial protocol.

BACKGROUND: Traumatic brain injury (TBI) is one of the major health and socioeconomic problems in the world. Immune-enhancing enteral formula has been proven to significantly reduce infection rate in TBI patients. One of the ingredients that can be used in immunonutrition formulas to reduce inflammation and oxidative stress is pycnogenol. OBJECTIVE: The objective of this work is to survey the effect of pycnogenol on the clinical, nutritional, and inflammatory status of TBI patients. METHODS: This is a double-blind, randomized controlled trial. Block randomization will be used. An intervention group will receive pycnogenol supplementation of 150 mg for 10 days and a control group will receive a placebo for the same duration. Inflammatory status (IL-6, IL- 1ß, C-reactive protein) and oxidative stress status (malondialdehyde, total antioxidant capacity), at the baseline, at the 5th day, and at the end of the study (10th day) will be measured. Clinical and nutritional status will be assessed three times during the intervention. The Sequential Organ Failure Assessment (SOFA) questionnaire for assessment of organ failure will be filled out every other day. The mortality rate will be calculated within 28 days of the start of the intervention. Weight, body mass index, and body composition will be measured. All analyses will be conducted by an initially assigned study arm in an intention-to-treat analysis. DISCUSSION: We expect that supplementation of 150 mg pycnogenol for 10 days will improve clinical and nutritional status and reduce the inflammation and oxidative stress of the TBI patients. TRIAL REGISTRATION: This trial is registered at clinicaltrials.gov (ref: NCT03777683) at 12/13/2018.

Effects of pycnogenol on cardiometabolic health: A systematic review and meta-analysis of randomized controlled trials.

AIM: Clinical trials on the effect of pycnogenol supplementation on cardiometabolic health have been controversial. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the potential effect of pycnogenol supplementation on cardiometabolic profile. METHODS: PubMed, Scopus, and ISI Web of Science databases were searched until October 2018. RCTs that evaluated the effects of pycnogenol on cardiometabolic parameters were included. DerSimonian and Laird random-effect models were used to compute the weighted mean differences (WMDs) and 95% confidence intervals (CIs). RESULTS: Twenty-four RCTs including 1594 participants were included in the meta-analysis. Pycnogenol significantly reduced fasting blood glucose (WMD: -5.86 mg/dl; 95% CI: -9.56, -2.15), glycated hemoglobin (WMD = -0.29%, 95%CI: -0.56, -0.01), systolic blood pressure (WMD: -2.54 mmhg; 95% CI: -4.08, -0.99), diastolic blood pressure (WMD: -1.76 mmhg; 95% CI: -3.12, -0.41), body mass index (WMD: -0.47 kg/m2; 95% CI: -0.90, -0.03), LDL cholesterol (WMD: -7.12 mg/dl; 95% CI: -13.66, -0.58) and increased HDL cholesterol (WMD: 3.27 mg/dl; 95% CI: 0.87, 5.66). CONCLUSION: This meta-analysis suggests that pycnogenol may have a role in preventing cardiometabolic disease. However, further well-designed RCTs are recommended to evaluate its long-term effects and explore the optimal duration of use and dosage.

Effect of Inhaled Colistin on the Treatment of Ventilator-Associated Pneumonia due to Multi-drug Resistant Acinetobacter.

BACKGROUND: Ventilator-Associated Pneumonia (VAP) is a hospital pneumonia that is considered in patients on mechanical ventilation for at least 48 hours with symptoms of new lower respiratory tract infections being reported in them. The present study reviews the effect of adding inhaled colistin in the treatment of ventilator-induced pulmonary infections in Intensive Care Unit (ICU) patients. MATERIALS AND METHODS: In this single blind clinical trial, patients admitted to the ICU with diagnosis of pulmonary infections caused by ventilator were investigated. In the treatment group, patients received 150 mg of colistin plus 1,000,000 units inhaled colistin every eight hours and in the control group only 300 mg of colistin every eight hours intravenously was given. Patients were followed up in terms of clinical findings for seven days after the initial diagnosis of infection. RESULTS: The results of this study showed that administration of inhaled colistin in patients admitted in ICU significantly improved culture indices, leukocyte, white blood cell count, chest X-ray, chest secretion, CPIS score and saccharification (SpO2) on the third and seventh days after treatment compared to the first day. CONCLUSION: Considering the positive effect of adding inhaled colistin to the treatment of patients admitted to ICU with pulmonary infections caused by ventilator with multi-drug resistant Acinetobacter, the use of combination drug therapy is recommended.