Tacrolimus-induced cholestatic hepatotoxicity after renal transplantation: a case report.

BACKGROUND: In this manuscript, we report a case of tacrolimus-associated hepatotoxicity in a kidney transplant recipient. CASE PRESENTATION: In this case report, a 56 years old Arab male patient who received a kidney transplant presented with icterus, weakness, and lethargy two weeks after transplantation and tacrolimus initiation. In laboratory analysis hyperbilirubinemia and a rise in hepatic enzymes were observed. All possible causes of hepatotoxicity were examined. The panel for infectious causes was negative. Drug-induced liver injury was diagnosed. The patient's immunosuppressive regimen was changed to a cyclosporine-based regimen and after this change bilirubin and hepatic enzymes decreased and the patient was discharged without signs and symptoms of hepatitis. CONCLUSION: It seems that the patient's hyperbilirubinemia was due to tacrolimus, and the patient's bilirubin decreased after stopping tacrolimus.

Clinical outcomes of kidney recipients with COVID-19 (COVID-19 in kidney recipients).

INTRODUCTION: The coronavirus disease 2019 (COVID-19) pandemic has caused significant mortality since late 2019. Patients undergoing kidney transplantation (KT) are prone to COVID-19 due to immunosuppressive drug use and various comorbidities such as hypertension and diabetes. METHODS: One hundred thirty-three KT recipients with COVID-19 were included in this retrospective cohort study. Hospital mortality was considered a primary outcome, while acute kidney injury (AKI) was considered a secondary outcome. Demographic information, maintenance immunosuppression, medical history, laboratory information, and echocardiographic and electrocardiography results of patients were recorded. Patients were also followed for 2 months post-discharge for post-COVID-19 symptoms, readmission, and transplant function. RESULTS: Regarding the primary outcome of the 133 patients, 13 died and 120 survived. The deceased patients were significantly older (median age, 64 vs. 50.5 years; p = 0.04) and had a significantly higher median serum creatinine level (p = 0.002) and lower median glomerular filtration rate (p = 0.010) than patients who survived. The incidence of AKI was 47.3%, more common in deceased patients (p = 0.038) than in patients who survived. Troponin levels were significantly higher in deceased patients and those with AKI (p = 0.0004 and p = 0.039, respectively) than in patients who survived and those without AKI. A multivariable Cox regression analysis revealed that older age (adjusted hazard ratio, 1.13; 95% confidence interval, 1.01-1.27) and AKI (adjusted hazard ratio, 3.43; 95% confidence interval, 1.34-8.79) were associated with in-hospital mortality. CONCLUSION: In conclusion, kidney recipients with COVID-19 had a higher mortality rate than the general population, with a higher prevalence in older individuals and those who experienced AKI during hospitalization than in patients who survived and those without AKI.

Effectiveness of Borage plus syrup on COVID-19 patients in intensive care units.

Introduction: COVID-19 (coronavirus disease-2019) still causes a high rate of death globally with no definite curative treatment described. The traditional plant Borage (Borago officinalis L.) is a good source of gamma-linolenic (GLA). We hypothesized that Borage plus syrup (BPS) would be beneficial in severe COVID-19 patients within an intensive care unit (ICU) setting. Materials and methods: A pilot single center, randomized trial with no placebo was undertaken. A total of 60 PCR-positive severe COVID-19 participants admitted to ICU from June 2020-December 2020 at Masih Daneshvari Hospital Tehran-Iran gave informed consent. The participants were randomly assigned to either Borage Plus Syrup (BPS, 5 ml for 5 days) (n = 30) or standard care (IFN-ß and favipiravir) as a control group (n = 30). Pao2/Fio2, serum ferritin, CRP, bilirubin, IL-6, TNF-α, ALT, AST, PCT and serum IL-8 was measured upon admission and on release. Results: All the measured parameters decreased significantly with BPS treatment. In the control group, most parameters significantly improved apart from AST and PCT. In addition, the suppression of serum TNF levels in the BPS group was greater than that seen in the control group (P ≤ 0.05). Moreover, the length of ICU stay was significantly lower in the BPS group compared with the control group (P ≤ 0.05). Conclusion: Our study shows that addition of BPS to the standard treatment regime of COVID-19 patients in ICU improved outcomes and reduced the length of ICU treatment. Natural products could be considered as new approaches for reducting the harmful consequences of COVID-19.

Comparing the Characteristics of Mucormycosis Between Cases with and without COVID-19; a Cross-sectional Study.

Introduction: Mucormycosis as a rare but life-threatening disease with 46-96% mortality, which challenged the healthcare system during the COVID-19 pandemic. This study aimed to compare the characteristics of mucormycosis between cases with and without COVID-19. Methods: This cross-sectional study was done in two referral hospitals, Imam Hossein and Labbafinezhad Hospitals, Tehran, Iran, between 21 March to 21 December 2021. Data related to all hospitalized adults subject with the diagnosis of mucormycosis during the study period was collected from patients' profiles and they were divided into two groups of with and without COVID-19 based on the results of real time PCR. Then demographic, clinical, and laboratory findings as well as outcomes were compared between the two groups. Results: 64 patients with the mean age of 53.40±10.32 (range: 33-74) years were studied (53.1% male). Forty-three (67.2%) out of the 64 subjects had a positive COVID-19 PCR test. The two groups had significant differences regarding some symptoms (cough (p < 0.001), shortness of breath (p = 0.006)), acute presentation (p = 0.027), using immunosuppressive (p = 0.013), using corticosteroid (p < 0.001), and outcomes (mortality (p = 0.018), need for intubation (p < 0.001)). 22 (34.3%) patients expired during hospital admission. Univariate analysis showed the association of in-hospital mortality with need for ventilation (p < 0.001), sinus involvement (p = 0.040), recent use of dexamethasone (p = 0.011), confirmed COVID-19 disease (p = 0.025), mean body mass index (BMI) (p =0.035), hemoglobin A1c (HbA1c) (p = 0.022), and median of blood urea nitrogen (BUN) (p =0.034). Based on the multivariate model, confirmed COVID-19 disease (OR = 5.01; 95% CI: 1.14-22.00; p = 0.033) and recent use of dexamethasone (OR= 4.08, 95% CI: 1.05-15.84, p = 0.042) were independent predictors of mortality in this series. Conclusion: The mucormycosis cases with concomitant COVID-19 disease had higher frequency of cough and shortness of breath, higher frequency of acute presentation, higher need for immunosuppressive, corticosteroid, and ventilator support, and higher mortality rate. The two groups were the same regarding age, gender, BMI, risk factors, underlying diseases, symptoms, and sites of involvement.

Case report: Bilateral simple Syndactyly in a toddler with maternal exposure to cabergoline.

Cabergoline is routinely prescribed in the management of prolactin excreting adenomas and is associated with low risk of congenital malformations and teratogenicity. Here, we reported the case of a bilateral simple syndactyly in a toddler with maternal exposure to cabergoline during the pregnancy. This association has not been previously described before.

Case Report: Pneumonia in a Patient With Combined Variable Immunodeficiency: COVID-19 or Pneumocystis Pneumonia?

Combined variable immunodeficiency (CVID) is a primary immunodeficiency, characterized by impairment in immune system function. These patients are susceptible to opportunistic infections, which may mimic COVID-19 manifestations. Also, misdiagnosis or delayed diagnosis of opportunistic infections can lead to perilous consequences. We report a 28-year-old woman with a history of combined variable immunodeficiency disorder (CVID) and ulcerative colitis (UC) complained of fever, cough, and dyspnea. According to the clinical and radiological manifestations and the COVID-19 epidemic, she was admitted with a primary diagnosis of COVID-19 pneumonia. After a week, the patient did not respond to treatment, so she underwent bronchoscopy. Using polymerase chain reaction (PCR) methodology, we detected DNA of Pneumocystis jirovecii, the causative agent of a life-threatening pneumonia (PCP), in respiratory specimens. The patient was hypersensitive to common PCP treatments, so she was treated with high-dose clindamycin. However, the patient's clinical condition aggravated. Besides, we found evidence of pneumothorax, pneumomediastinum, and pneumopericardium in chest CT scan. We inserted a catheter for the patient to evacuate the air inside the mediastinum. Also, we added caspofungin to the treatment. The patient eventually recovered and was discharged from the hospital about a week later. Thus, during the COVID-19 epidemic, in febrile patients with respiratory symptoms, physicians should not think only of COVID-19. They must consider opportunistic infections such as PCP, especially in immunocompromised patients.

Evaluation of medication reconciliation process in internal medicine wards of an academic medical center by a pharmacist: errors and risk factors.

Medication reconciliation based on complete medication histories has been introduced to minimize medication errors and its associated healthcare costs in the transitions of care. In this study, to evaluate the routine process of medication reconciliation in an academic medical center, medication history taken at the time of admission by physicians and the first order prescribed in the hospital was compared to a comprehensive reconciliation form filled by a pharmacist using direct interview of the patients and caregivers, patient's insurance records and medication packages they brought from home. Two hundred and fifty-seven patients admitted in the internal wards of an academic medical center between June and September 2019 were investigated. In 6% of the patients, drug history was not included in the medical history form. Other patients were using 8.59 drugs in average, with a mean of 3.55 medication discrepancies in the history-taking process. Most commonly occurring errors were drug omissions (2.23 per patient on average) and incorrect frequency (0.96 per patient on average). There was a mean of 0.7 potentially harmful discrepancies for each patient. The mean number of drug discrepancies in new prescriptions from the hospital was 1.25, and almost half of patients had a potentially harmful discrepancies reordered in the hospital. There was no statistically meaningful relationship between patients' gender, physicians' gender, or the time of history taking and the total number of medication errors. History of ischemic heart disease was significantly associated with higher number of medication errors (p = 0.05). The results suggest that the medication reconciliation process in this academic center is inefficient. Using a systematic approach in medication reconciliation and gathering the best possible medication history, with a pharmacist who has better understanding of drugs' potential interactions and harmful errors can improve this process and prevent such errors in the future.

Rapid spread and high mortality due to community-acquired pneumonia caused by Acinetobacter baumannii (CAP-AB) in a Covid-19 intensive care unit.

Acinetobacter baumannii is a rare but dangerous gram-negative bacteria causing nosocomial infections, especially in intensive care units. The increased use of antibiotics in the treatment of bacterial infections leads to drug resistance, delays, or failures in treatment. The patient is a 48-year-old man with coronavirus disease (COVID-19) being treated in the intensive care unit. After contracting Acinetobacter baumannii, the patient's condition deteriorated, and he developed severe pulmonary problems. Due to the unknown presence of Acinetobacter baumannii in the patient, this bacterium transmitted to six other patients in the ward, which resulted in their deaths. In this report, we describe the causes and risk factors of the disease, and the results of laboratory tests and therapeutic processes.

Mental Health Status among Healthcare Workers during COVID-19 Pandemic.

Objective: COVID-19, which is an international concern by far, had fundamental impacts on mental health of medical staff. Healthcare workers are the high-risk group to endure the emotional outcomes brought about by the outbreak. This study assesses the mental consequences of healthcare workers during the acute phase of COVID-19 pandemic in Tehran. Method : We conducted a cross-sectional study on healthcare workers from two tertiary referral hospitals in Tehran province. A total of 222 of the staff participated in the study. Our questionnaires comprised Impact of Event Scale-Revised (IES-R) and 12-item General Health Questionnaire (GHQ-12), which were handed to participants to obtain data on their general mental problems in addition to the psychological impacts of the evolving virus on this particular group. Epidemiologic and sociodemographic information of participants, level of perceiving exposure to disease, and underlying diseases of each of them were gathered during the recruitment period. Results: Results showed high probabilities (98.2%) in mental disorders among healthcare workers. Since our study was done during the initial phase of the pandemic, development of mental issues due to the newly emerged infectious virus was expected. However, we recorded mild (41.4%) to moderate (31.5%) impact of this novel virus. The possibility of having mental problems was much higher in females, assistant nurses, individuals with lower education, and those who provided care for COVID-19 patients. Conclusion: COVID-19 has brought about increased distress among healthcare workers. Noticeably, the forefront group in combating this virus bear the most emotional complications. Thus, efforts should be taken into practice to provide proper psychological support for this vulnerable group.

Assessing multiple sclerosis-related quality of life among Iranian patients using the MSQOL-54 tool: a cross-sectional study.

BACKGROUND: Multiple sclerosis (MS) is a chronic autoimmune disease and is one of the most costly medical conditions that imposed families with catastrophic health expenditures. There is an increasing trend in using alternative medicines including, dietary supplements, herbs, vitamins, and minerals. To date, the association between dietary as well as herbal supplements and QoL in MS patients is under researched; thus, this study aimed to assess the association between the self-reported supplement used and QoL between MS patients. METHODS: This cross-sectional study was conducted on patients with MS referring to Shahid Kazemi Pharmacy, based in the city of Tehran, Iran, as a national pharmacy providing specialized pharmaceutical products and pharmaceutical care to patients. The Multiple Sclerosis Quality of Life-54 (MSQoL-54) tools was performed to evaluate MS patients QoL. RESULTS: A total number of 382 patients with MS participated in this study. They include 89 (23.3%) men and 293 (76.7%) women, aged 40 ± 10.9 years old. The overall score of the MSQoL-54 questionnaire was 41.58 out of 100. Physical health composite (PHC) and mental health composite (MHC) were 69.60 and 62.99 from 100, respectively. This study revealed that 76.4% of patients used at least one vitamin daily; 92.4% of patients do not receive any herbal product. Vitamin D is the most widely used supplement, followed by calcium, while vitamin C is the least consumed. No correlation was observed regarding supplement use and overall QoL, PHC, or MHC. There were no significant differences between QoL's dimensions score in patients who used supplements. The results showed that increasing the number of supplements used did not relate to overall QoL, PHC, or MHC. In addition, there was not any correlation between the duration used of supplements and QoL's dimensions score in MS patients (p-value> 0.05). CONCLUSIONS: The dietary supplement appears to be popular among MS patients. The study results showed that the number of supplementations and their long-term use in patients with MS were not associated with higher QoL. Similarly, the herbal supplements have failed to improve QoL.

Safety and efficacy of Favipiravir in moderate to severe SARS-CoV-2 pneumonia.

BACKGROUND: We examined the safety and efficacy of a treatment protocol containing Favipiravir for the treatment of SARS-CoV-2. METHODS: We did a multicenter randomized open-labeled clinical trial on moderate to severe cases infections of SARS-CoV-2. Patients with typical ground glass appearance on chest computerized tomography scan (CT scan) and oxygen saturation (SpO2) of less than 93% were enrolled. They were randomly allocated into Favipiravir (1.6 gr loading, 1.8 gr daily) and Lopinavir/Ritonavir (800/200 mg daily) treatment regimens in addition to standard care. In-hospital mortality, ICU admission, intubation, time to clinical recovery, changes in daily SpO2 after 5 min discontinuation of supplemental oxygen, and length of hospital stay were quantified and compared in the two groups. RESULTS: 380 patients were randomly allocated into Favipiravir (193) and Lopinavir/Ritonavir (187) groups in 13 centers. The number of deaths, intubations, and ICU admissions were not significantly different (26, 27, 31 and 21, 17, 25 respectively). Mean hospital stay was also not different (7.9 days [SD = 6] in the Favipiravir and 8.1 [SD = 6.5] days in Lopinavir/Ritonavir groups) (p = 0.61). Time to clinical recovery in the Favipiravir group was similar to Lopinavir/Ritonavir group (HR = 0.94, 95% CI 0.75 - 1.17) and likewise the changes in the daily SpO2 after discontinuation of supplemental oxygen (p = 0.46) CONCLUSION: Adding Favipiravir to the treatment protocol did not reduce the number of ICU admissions or intubations or In-hospital mortality compared to Lopinavir/Ritonavir regimen. It also did not shorten time to clinical recovery and length of hospital stay.

Evaluation of pharmacokinetic and pharmacodynamic parameters of meropenem in critically ill patients with acute kidney disease.

PURPOSE: No study has been evaluated pharmacokinetic (PK) and pharmacodynamic (PD) properties of ß-lactam antibiotics in patients with acute kidney injury (AKI), not requiring renal replacement therapy (RRT). We evaluated the time that plasma concentrations remain above four times the MIC (ft > 4MIC) and PK parameters of meropenem in this population. METHODS: In this prospective, randomized clinical trial (RCT), all patients received standard dose (3 g daily) of meropenem for 48 h, then randomly allocated in standard or adjusted groups. The standard group received meropenem without dose adjustment. In the adjusted group, the meropenem dose was adjusted based on the Cockcroft-Gault(C-G) equation. Meropenem concentrations were measured at the peak and trough times on the 2nd and 5th days of the study. RESULTS: On the 2nd day of the study, 3 out of 10 (30%) of patients attained the PD target (≥ 80%ft > 4MIC). In the 5th day of the study, the PD target was attained in 2 out of 10 (20%) and 1 out of 5 (20%) of patients who received standard and adjusted doses of meropenem, respectively (p = 1). In all samples, increased volume of distribution (Vd) (median; IQR) (46.04; 23.06-103.18 L), terminal half-life (T1/2) (4.51; 2.67-8.88 h) and decreased clearance (6.52; 4.43-10.16 L/h) have been shown. CONCLUSION: In critically ill patients with AKI, who not receive RRT, standard doses, and adjusted according to renal function of meropenem failed to achieve PD target of ≥ 80%ft > 4MIC. Higher doses are required for this target. RETROSPECTIVELY REGISTERED: The study protocol with registered retrospectively and approved on January 19, 2019, with the number of IRCT20160412027346N5.

Evaluating the Effect of Acetazolamide on the Prevention of Post-operative Acute Kidney Injury after Coronary Artery Bypass Grafting Surgery: A Randomized, Open-labeled Clinical Trial.

Acute kidney injury (AKI) is a common complication after coronary artery bypass grafting (CABG) surgery and can be linked to the increased morbidity and mortality. Therefore, in the present study, the effect of preoperative administration of acetazolamide was evaluated to investigate whether it could prevent occurrence of post-operative AKI after CABG surgery. In this randomized controlled clinical trial, 130 patients who were candidates to undergo elective CABG surgery from January 21, 2020 to February 8, 2021 were randomly allocated to intervention group (receiving 500 mg of acetazolamide orally 2 h preoperatively) and control group. The patients were evaluated for AKI based on the kidney disease- improving global outcomes (KDIGO) criteria based on their serum creatinine (SCr) level and urine output until 7 days postoperatively. There was no significant difference in baseline demographics between the two groups. The total incidence of AKI was measured as 43%. Analysis of post-operative AKI incidence showed no statistically significant difference between the two groups (P = 0.860). Mean post-operative SCr level on day 1 was significantly higher in the acetazolamide group (P = 0.036). A significant difference was found in length of hospitalization stay between the groups, which was higher in the control group (P = 0.006). Our results did not demonstrate a significant protective effect of acetazolamide on incidence of post-operative AKI in the patients undergone elective on-pump CABG surgery.

Early Graft Function in Deceased Donor Renal Recipients: Role of N-Acetylcysteine.

Reduced graft function (RGF) in donor renal transplant recipients is caused by oxidative damage due to extensive ischemia-reperfusion (I/R) injury during transplantation. Neutrophil gelatinase-associated lipocalin (NGAL) is a promising biomarker to detect tubular injury early after renal transplantation. N-acetylcysteine (NAC) is a potent antioxidant that can reduce I/R injury by improving oxidative damage. The aim of the present study is to assess the efficacy of NAC in improving graft function and reducing renal tubular injury in deceased donor renal transplant recipients. A double-blind, randomized clinical trial was conducted on 50 deceased donor renal transplant recipients. The patients were randomized into two groups, receiving either 600 mg NAC twice daily, or placebo (days 0 to 5). Results were assessed based on the rate of RGF, levels of plasma NGAL (p-NGAL) and the estimated glomerular filtration rate (eGFR). The rate of RGF was significantly lower in the patients receiving NAC vs. placebo (21.4% vs. 50%). The measurement of p-NGAL levels showed that the patients in the NAC group had significantly greater reduction of p-NGAL by both days 1 and 5 post-transplantation than those in the placebo group. A near steady-state eGFR level was reached by week 1 in the NAC group, however, the improvement of eGFR was significantly slower in the placebo group and a near steady-state was only achieved by week 4. NAC has promising potential in reducing tubular injury and improving graft function, evidenced by significant reduction in the rate of RGF and levels of p-NGAL.

Low rate of COVID-19 pneumonia in kidney transplant recipients-A battle between infection and immune response?

BACKGROUND: With COVID-19 pandemic, concerns about kidney transplant recipients are rising. However, the incidence, clinical course, outcome, and predictive factors of disease severity are obscured. METHODS: We describe clinical and laboratory manifestations, radiologic findings, clinical course, and finally outcome of kidney transplant recipients with COVID-19 pneumonia. RESULTS: Of 2493 kidney transplant recipients under follow-up in our clinic, 19 cases (4 cases diagnosed based on radiologic findings) were admitted. The mean age of patients was 47.6 ± 12.4 years, and the mean time from transplantation was 115.6 ± 70.3 months. Lymphopenia and eosinopenia were 84.2% and 78.9%, respectively. Nine patients did not survive the hospital course. History of acute rejection during the past 12 months, diabetes, higher N/L ratio, lower platelet count, elevated N/L x CRP, higher levels of LDH, positive D-dimer, higher troponin, and prolonged PT were associated with mortality. Among patients with positive COVID-19 test, history of acute rejection, low platelet count, and positive D-dimer were associated with poor outcome. Treatment with cyclosporine was associated with better clinical outcome. CONCLUSIONS: Low rate of admission in transplant recipients specially in the very first years of transplantation might be due to protective effects of immunosuppressive agents against cytokine storm or modification of immunity function. We suggest evaluation of T-cell number, function, and cytokine profile as a guide to manage COVID-19 mainly in patients with higher risk of mortality.

Adding Colchicine to the Antiretroviral Medication - Lopinavir/Ritonavir (Kaletra) in Hospitalized Patients with Non-Severe Covid-19 Pneumonia: A Structured Summary of a Study Protocol for a Randomized Controlled Trial.

OBJECTIVES: Colchicine is a well-known drug, which has been used for years to treat a wide range of rheumatic and inflammatory disorders. It helps break the cycle of inflammation through diverse mechanisms including reducing Intereukin-6, Interleukin-8, Tumour Necrosis Factor-alpha besides controlling oxidative stress pathways which all are important and pathologic components in the clinical course and outcome of patients infected with COVID-19. This study aims to assess the anti-inflammatory effects of colchicine in non-severe hospitalized COVID-19 patients. TRIAL DESIGN: Prospective, randomized (1:1 ratio), double blind study with parallel group design. PARTICIPANTS: Hospitalized patients with positive nasopharyngeal swab for COVID-19 infection (RT -PCR) and lung Computed tomography scan involvement compatible with COVID-19 pneumonia. The patients are not severely hypoxic, do not need intubation or invasive oxygenation. EXCLUSION CRITERIA: known hypersensitivity to colchicine; known hepatic failure; estimated glomerular filtration rate (eGFR)<30 ml/min/1.73m2 (by the CKD-EPI Creatinine Equation for Glomerular Filtration Rate (GFR) which estimates GFR based on serum creatinine. ; kidney transplant recipients, using Digoxin, QTc >450 msec. Participants will be recruited from inpatients at Labbafinejad Meidcal Center , Tehran, Iran. INTERVENTION AND COMPARATOR: Eligible enrolled patients will be randomized into two groups. Group A will receive the antiretroviral Lopinavir/Ritonavir (Kaletra) while group B will receive Lopinavir/Ritonavir (Kaletra) + Colchicine 1.5 mg loading then 0.5 mg twice daily orally. All patients in both groups will receive the same amounts of essential minerals, vitamins as antioxidants, and antibiotics. Patients of both groups will be treated under optimal treatment based on the CDC and WHO guidelines and national consensus proposed in Iran including the same dosages of Lopinavir/Ritonavir, antibiotics, trace elements and antioxidants while only in group-B patients Colchicine will be added on top of this protocol. MAIN OUTCOMES: Primary: Time for clinical improvement and lung CT score changes 14 days after treatment. Secondary: 14 days after treatment - C-Reactive Protein test x Neutrophil to Lymphocyte Ratio , Interleukin-6, malondialdehyde (MDA) levels reduction - Percentage of patients who require supplemental Oxygen - Mean hospital stay length RANDOMISATION: Patients will be allocated to each group (ratio 1:1) by using an online randomization tool: http://www.graphpad.com/quickcalcs/index.cfm BLINDING (MASKING): This will be a double-blind study in which participants and those assessing the final outcomes will be blinded to group assignment. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): Regarding the pandemic crisis and our center capacity to hospitalize confirmed COVID-19 patients, a total of 80 patients was found to be logical to be randomized into two groups of 40- patients. TRIAL STATUS: Recruitment is ongoing. Recruitment began on 20/03/2020 and the date by which the recruitment is anticipated to be completed is 30/05/2020. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04360980, registered 24/04/2020. 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.

Omega-3 in Patients Undergoing Continuous Ambulatory Peritoneal Dialysis, Effects on Inflammatory Markers and Lipid Profile.

INTRODUCTION: CKD is one of the most prevalent entities associated with high morbidity and mortality. Most of the patients with renal diseases, particularly patients undergoing dialysis, suffer from cardiovascular disease and it is necessary to employ appropriate strategies to prevent and manage this complication. The aim of this study was to evaluate the anti-inflammatory effects of omega-3 in patients undergoing CAPD. METHODS: Nineteen CAPD patients with certain inclusion and exclusion criteria enrolled in this study. Omega-3 capsules with a dose of 1 g/d up to three months, were administrated. Some inflammatory markers such as ESR, CRP, HS-CRP, IL-6, MDA, and homocysteine were measured in three phases. In addition, lipid profile including triglyceride, cholesterol, LDL, and HDL were measured. RESULTS: Results of this study showed that CRP, HS-CRP, and homocysteine levels increased insignificantly (P > .05) whereas, MDA level was increased significantly (P < .05). ESR and IL-6 levels both decreased but did not show any statistically significance (P > .05). Results of lipid profile also suggested that none of the lipid levels changed significantly (P > .05). CONCLUSION: It is necessary to design large trials in order to understand clear effects of omega-3 on inflammatory markers in PD patients. In addition, the results of this current pilot study should be interpreted with caution.

N-acetylcysteine decreases urinary level of neutrophil gelatinase-associated lipocalin in deceased-donor renal transplant recipients: a randomized clinical trial.

CONTEXT: Acute kidney injury (AKI) is a common complication after kidney transplantation (KT), especially in recipients from deceased donors. Urinary neutrophil gelatinase-associated lipocalin (u-NGAL) is an early and sensitive marker of AKI after transplantation. OBJECTIVES: We assessed the renoprotective effect of N-acetylcysteine (NAC) on u-NGAL levels as an early prognostic marker of graft function immediately after transplantation. MATERIALS AND METHODS: A double-blind, randomized, placebo-controlled trial was conducted on 70 deceased-donor KT recipients ( www.irct.ir , trial registration number: IRCT2014090214693N4). Patients received 600 mg oral NAC or placebo twice daily from day 0 to 5 and urine samples were taken before, and on the first and fifth days after transplantation. U-NGAL and early graft function were compared between the two groups. RESULTS: NAC significantly reduced u-NGAL levels compared to placebo (p value = 0.02), while improvement in early graft function with NAC did not reach statistical significance. CONCLUSIONS: This study showed that NAC administration in deceased-donor KT recipients can reduce tubular kidney injury, evidenced by u-NGAL measurements. Improvement in early graft function needs a larger sample size to reach a statistical conclusion.