Effect of High-dose Vitamin D on IL-1ß Blood Level in Patients with Moderate Stroke: A Randomized Clinical Trial.

Background: Vitamin D has neuroprotective and anti-inflammatory effects in stroke patients, but its effect on pro-inflammatory and inflammatory cytokines, especially IL-1, has been investigated in a few trials. Objectives: This study aimed to determine the effect of prescribing a high dose of vitamin D on the anti-inflammatory parameters, short-term and long-term prognosis of patients with ischemic stroke. Methods: This randomized clinical trial was performed on 42 patients randomly divided into two equal groups of 21 in Imam Hussein Hospital. The patients were allocated through block randomization methods to receive 300,000 units of vitamin D (intramuscularly) or not receive it as a control group. Age, gender, and clinical and laboratory information were recorded. The stroke severity was calculated according to the National Institute of Health Stroke Scale (NIHSS) at the beginning of hospitalization and upon hospital discharge. The 3-month prognosis of the patients was recorded according to the Barthel criteria three months after the stroke. Vitamin D3 levels were recorded before and after injection, while the neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) were assessed on the first day and for 7 consecutive days after hospitalization. All statistical analyses were performed using STATA version 14. A P-value < 0.05 was considered significant. Results: The mean age of the patients was 61.45 ± 4.74 years. There were 18 female (42.86%) and 24 male patients (57.14%). In the vitamin D group, the mean IL-1 decreased compared to before the intervention (-23.60 ± 103.83), but this decrease was not statistically significant (P = 0.070). In addition, the changes in IL-1 after the intervention were statistically different between the two groups (mean difference of -23.60 ± 103.83 in the vitamin D group vs. 15.96 ± 9.64 in the control group). The mean IL-6 decreased in both groups after the intervention compared to before, although these changes were not statistically significant (P > 0.05). In the group receiving vitamin D compared to the control group, the mean NLR decreased by about 2 units, the PLR decreased by about 10 units, and the NIHSS score decreased by about one unit during the study. However, these changes were not statistically significant (P > 0.05). Conclusions: A high dose of vitamin D can improve the NIHSS score and decrease IL-1 and IL-6, although these changes were not statistically significant. The mean NLR and PLR decreased after using high-dose vitamin D.

Sinopharm (HB02)-associated vaccine-induced immune thrombotic thrombocytopenia: a case report.

BACKGROUND: Vaccine-induced thrombotic thrombocytopenia is associated with the coronavirus disease 2019 vaccines. It has been reported by vector-based vaccines. To the best of our knowledge, there is no report about vaccine-induced thrombotic thrombocytopenia in whole-virus vaccines. We are presenting the first case of vaccine-induced thrombotic thrombocytopenia with this type of vaccine. CASE PRESENTATION: An 18-year-old male Caucasian patient with complaints of severe abdominal, low back, and lower extremity pain presented to the medical center. He received the first dose of the Sinopharm (HB02) vaccine against coronavirus disease 2019 10 days before hospital attendance. In the laboratory examination, decreased platelet count and increased D-dimer were observed. During hospital admission, the diagnosis of pulmonary embolism was reached. He received vaccine-induced thrombotic thrombocytopenia therapy consisting of intravenous immune globulin and direct oral anticoagulant. Platelet count increased and he was discharged after 1 month. CONCLUSION: This case highlights the possibility of vaccine-induced thrombotic thrombocytopenia occurrence by whole-virus coronavirus disease 2019 vaccines. Compared with vector-based vaccines, this phenomenon is rare for whole-virus vaccines. More studies on this type of vaccine regarding thrombotic thrombocytopenia should be considered.

Effect of Oral Caffeine on Weaning from Mechanical Ventilation in Intubated ICU Patients.

Background: The role of caffeine as a brain stimulant in improving the respiratory characteristics of patients under mechanical ventilation is unclear. This study aimed at determining the effect of oral caffeine in helping to release (Liberation) from the ventilator in intubated patients under mechanical ventilation admitted to the intensive care unit. Materials and Methods: General ICU patients with more than 48 hours of dependency on a ventilator were randomly divided into two groups. The intervention group received 200mg caffeine tablets twice a day through a gastric tube, while the control group received a placebo of the same amount. Every day, patients were assessed for the likelihood of being disconnected from the device. If their clinical condition was deemed suitable, the device mode was switched to spontaneous, and their Rapid Shallow Breathing Index (RSBI) was calculated. Based on this information, a decision was made regarding whether to proceed with weaning. Results: Caffeine use in ICU patients significantly reduced the airway resistance index of patients (P <0.05). However, although this drug reduced the length of hospital stay in the ICU and the duration of intubation of patients, these changes were not statistically significant (P> 0.05). Conclusion: Caffeine may improve respiratory status and reduce the duration of intubation and hospitalization in the ICU.

Using Two Predictor Scoring Systems Together to Increase the Chance of Identifying the Augmented Renal Clearance Phenomenon: A Cross-sectional Study.

INTRODUCTION: Augmented Renal Clearance (ARC) reflects a measured creatinine clearance (CrCl) of more than 130 ml/min. Also, there are two scoring systems for the prediction of the ARC phenomenon i.e., the ARC score (ARCS) and the Augmented Renal Clearance in Trauma Intensive Care score (ARCTICs). The objectives of the current study were the evaluation the effect of using both scoring systems, on the chance of identifying this phenomenon and evaluating the accuracy of the three commonly used formulas for estimating glomerular filtration rate (eGFR) in ICU patients. METHODS: In this prospective cross-sectional study, the CrCls of all patients admitted to the ICU were evaluated by using ARCS and ARCTICS, and for high-risk subjects based on scoring systems, a 12-hour urine sample was collected to measure CrCl. Besides, daily serum creatinine was recorded to estimate the daily eGFR. RESULTS: During the study period, 810 subjects were evaluated and 145 were categorized as high-risk using scoring systems. The ARC phenomenon was confirmed in 79 patients on the recruitment day and 81.01 and 18.98% of them were recruited by ARCS and ARCTICS, respectively. The ROC curves showed AUCs > 0.5 for CockcroftGault (C-G) and CKD-EPI with the cut-off of 100.48 and 107.05 mL/min/ 1.73m2, respectively; to detect the ARC phenomenon. CONCLUSION: We recommend using ARCS and ARCTICS simultaneously to assess critically ill patients regarding the possibility of the ARC phenomenon which should be confirmed by using urinary CrCl, as none of the formulas could accurately detect the ARC phenomenon, neither the 12-hour CrCl.  DOI: 10.52547/ijkd.6695.

A randomized controlled clinical trial on efficacy and safety of anakinra in patients with severe COVID-19.

INTRODUCTION: Hyperinflammatory state has a role in the pathogenesis of COVID-19. Anakinra could reduce inflammation and help to combat the condition. In this study, we aimed to assess the safety and efficacy of anakinra (PerkinRA®) in severe COVID-19. METHOD: The study was an open-label, randomized, controlled trial conducted in Imam Hossein Medical Center from May to July 2020. Patients with a confirmed diagnosis of COVID-19 were included in this study. We administered anakinra 100 mg daily intravenously. All patients received COVID-19 pharmacotherapy based on the represented national guideline. The need for invasive mechanical ventilation is considered the primary outcome. RESULTS: Thirty patients were included in this study, and 15 of them received Anakinra. Nineteen patients were male (63.3%), and 11 were female (36.7%). The mean age of patients was 55.77 ± 15.89 years. In the intervention group, the need for invasive mechanical ventilation was significantly reduced compared to the control group (20.0% vs. 66.7%, p = .010). Also, these patients had a significantly lower length of hospital stay (p = .043). No significant higher rate of infection was recorded. CONCLUSION: Anakinra as an immunomodulatory agent has been associated with the reduced need for mechanical ventilation in patients admitted to intensive care units because of severe COVID-19. The medication reduced the hospital length of stay. Furthermore, no increased risk of infection was observed. Further randomized placebo-controlled trials with a larger sample size are needed to confirm these findings.

Blood purification with CytoSorb in critically ill COVID-19 patients: A case series of 26 patients.

Severe forms of the coronavirus disease 2019 (COVID-19) can progress to sepsis-like complications accompanied by "cytokine storm" for which the most effective treatment has not yet been established. Our study describes the results of CytoSorb hemoadsorption in COVID-19 patients treated on the intensive care unit (ICU). In this retrospective study, 26 patients with COVID-19 and acute respiratory distress syndrome (ARDS) were treated with hemoadsorption therapy. Pre-, and post-treatment values (clinical and laboratory) were compared. Data are expressed as mean (confidence intervals, CI), or median [interquartile ranges, IQR], as appropriate. Patients received 2 hemoadsorption treatments. This resulted in a significant decrease in norepinephrine requirements, and inflammatory marker plasma concentrations (procalcitonin, C-reactive protein, ferritin) when comparing pre versus post treatment levels. The PaO2 /FiO2 and overall organ function (ie, Sequential Organ Failure Assessment-SOFA score) also improved significantly. Patients stayed on the ICU for 9 days and 21 of them survived. To the best of our knowledge, this is one of the largest case series to date reporting early experiences on extracorporeal hemoadsorption therapy in SARS-CoV-2 positive patients with hyperinflammation and moderate ARDS. Treatment proved to be effective, technically feasible and well-tolerated.

Impact of a High-protein Nutritional Intake on the Clinical Outcome of the Neurocritical Patients.

Disease-related malnutrition of neurocritical illness harms its treatment, which increases the mortality rate. The aim of this study was evaluating the effect of a high protein diet on the dietary factors, clinical outcome, and mortality rate of neurocritical patients. In a randomized controlled trial, 15 neurocritical patients were recruited in each group. The patients in the intervention and control groups received high protein and conventional protein regimens, respectively. The Clinical Extended Glasgow Outcome Scale (GOSE) measured at one, two, and three months later. Acute Physiology and Chronic Health Evaluation II (APACHE-II) score, Glasgow Coma Scale, the serum level of transthyretin (TTR) on the first, 3rd and fifth days of admission, and nitrogen balance (NB) at the baseline and fifth day of the study were recorded. Thirty patients, 15 in each group, entered into the study. There was no statistically significant difference in the baseline characteristics of the patients between the two groups of the study. The 28-days-mortality rate in the intervention and control group were 33.3% (n = 5) and 73.3% (n = 11), P-value = 0.034, respectively. The GOSE scores were higher in the patients who received a high protein diet, and lower in the patients with lower baseline TTR, higher APACHE-II score, older age, and a baseline negative nitrogen balance. The high protein diet may decrease the mortality rate, and improve the clinical outcome of neurocritical patients. The baseline TTR level, APACHE II score, and NB are prognostic factors for the prediction of the GOSE in neurocritical patients.

Maternal death due to COVID-19.

BACKGROUND: Despite 2.5 million infections and 169,000 deaths worldwide (as of April 20, 2020), no maternal deaths and only a few pregnant women afflicted with severe respiratory morbidity have been reported to be related to COVID-19 disease. Given the disproportionate burden of severe and fatal respiratory disease previously documented among pregnant women following other coronavirus-related outbreaks (SARS-CoV in 2003 and MERS-CoV in 2012) and influenza pandemics over the last century, the absence of reported maternal morbidity and mortality with COVID-19 disease is unexpected. OBJECTIVE: To describe maternal and perinatal outcomes and death in a case series of pregnant women with COVID-19 disease. STUDY DESIGN: We describe here a multiinstitution adjudicated case series from Iran that includes 9 pregnant women diagnosed with severe COVID-19 disease in their second or third trimester. All 9 pregnant women received a diagnosis of SARS-CoV-2 infection by reverse transcription polymerase chain reaction nucleic acid testing. Outcomes of these women were compared with their familial/household members with contact to the affected patient on or after their symptom onset. All data were reported at death or after a minimum of 14 days from date of admission with COVID-19 disease. RESULTS: Among 9 pregnant women with severe COVID-19 disease, at the time of reporting, 7 of 9 died, 1 of 9 remains critically ill and ventilator dependent, and 1 of 9 recovered after prolonged hospitalization. We obtained self-verified familial/household cohort data in all 9 cases, and in each and every instance, maternal outcomes were more severe compared with outcomes of other high- and low-risk familial/household members (n=33 members for comparison). CONCLUSION: We report herein maternal deaths owing to COVID-19 disease. Until rigorously collected surveillance data emerge, it is prudent to be aware of the potential for maternal death among pregnant women diagnosed as having COVID-19 disease in their second or third trimester.

Comparison of Intravenous Ampicillin-sulbactam Plus Nebulized Colistin with Intravenous Colistin Plus Nebulized Colistin in Treatment of Ventilator Associated Pneumonia Caused by Multi Drug Resistant Acinetobacter Baumannii: Randomized Open Label Trial.

The purpose of this study was evaluating the efficacy and safety of intravenous (IV) ampicillin-sulbactam plus nebulized colistin in the treatment of Ventilator-Associated Pneumonia (VAP) caused by MDR Acinetobacter (MDRA) in ICU patients as an alternative to IV plus nebulized colistin. In this single-blinded RCT, one group received IV colistin and another group IV ampicillin-sulbactam (16 and 12 patients from total 28 patients, respectively) for 14 days or since clinical response. Both groups received nebulized colistin by mesh nebulizer. There were no statistically significant differences between the 2 groups in baseline characteristics and previous antibiotic therapy. In follow up period, no significant difference was observed between 2 groups in rate of microbiological eradication, clinical signs of VAP improvement, survival rate and length of hospital as well as ICU stays. Although we have found no significant differences in Acute Kidney Injury (AKI) incidence between two groups, comparison of cumulative patient-days with stages 2 and 3 AKI with days with no or stage 1 AKI, according to AKIN criteria, revealed significant difference in IV colistin versus IV ampicillin-sulbactam group (p = 0.013). The results demonstrated that the high dose IV ampicillin-sulbactam plus nebulized colistin regimen has comparable efficacy with IV plus nebulized colistin in the treatment of VAP caused by MDRA, with sensitivity to colistin only, with probably lower incidence of kidney injury.

Interim Study: Comparison Of Safety And Efficacy of Levofloxacin Plus Colistin Regimen With Levofloxacin Plus High Dose Ampicillin/Sulbactam Infusion In Treatment of Ventilator-Associated Pneumonia Due To Multi Drug Resistant Acinetobacter.

Due to the emerging antibiotic resistance of Acinetobacter, which is the leading cause of ventilator-associated pneumonia (VAP) in critically ill patients, there is an urgent need for studies comparing various antibiotic regimens for its treatment. In this single blinded randomized clinical trial, adult patients with VAP due to multi drug resistant Acinetobacter (MDRA), were randomly assigned to receive 9×109 unit loading dose of colistin followed by 4.5×109 unit intravenously twice daily plus 750 mg intravenous levofloxacin daily or continuous infusion of ampicillin/sulbactam, 24g daily plus 750mg IV levofloxacin daily. Dose and dosing interval were adjusted according to serum creatinine levels during the study. Clinical and microbiological cure, inflammatory biomarkers, and possible adverse effects were recorded in participants. Twenty-nine patients were recruited (14 in colistin and 15 in ampicillin/sulbactam groups). Three patients were excluded in each group. Clinical response occurred in 3 (27%) and 10 (83%) in colistin and ampicillin-sulbactam arms, respectively (P = 0.007). Nephrotoxicity happened in 6 (54%) and 1 (8%) of cases in colistin and ampicillin-sulbactam groups, (P = 0.016). 14-day and 28-day survival rate were significantly higher in ampicillin-sulbactam group compared to colistin arm with P values of 0.002 and 0.049, respectively. This study revealed that levofloxacin plus high dose ampicillin/sulbactam as continuous infusion is more effective than levofloxacin plus colistin in patients with MDR Acinetobacter VAP with significantly lower risk of nephrotoxicity.

Effect of Memantine on Serum Levels of Neuron-Specific Enolase and on the Glasgow Coma Scale in Patients With Moderate Traumatic Brain Injury.

Traumatic brain injury (TBI) is a major cause of disability and death globally. Despite significant progress in neuromonitoring and neuroprotection, pharmacological interventions have failed to generate favorable results. We examined the effect of memantine on serum levels of neuron-specific enolase (NSE), a marker of neuronal damage, and the Glasgow Coma Scale (GCS) in patients with moderate TBI. Patients were randomly assigned to the control group (who received standard TBI management) and the treatment group (who, alongside their standard management, received enteral memantine 30 mg twice daily for 7 days). Patients' clinical data, GCS, findings of head computed tomography, and serum NSE levels were collected during the study. Forty-one patients were randomized into the control and treatment groups, 19 and 22 patients respectively. Baseline characteristics and serum NSE levels were not significantly different between the 2 groups. The mean serum NSE levels for the memantine and the control groups on day 3 were 7.95 ± 2.86 and 12.33 ± 7.09 ng/mL, respectively (P = .05), and on day 7 were 5.03 ± 3.25 and 10.04 ± 5.72 ng/mL, respectively (P = .003). The mean GCS on day 3 was 12.3 ± 2.0 and 10.9 ± 1.9 in the memantine and control groups, respectively (P = .03). Serum NSE levels and GCS changes were negatively correlated (r = -0.368, P = .02). Patients with moderate TBI who received memantine had significantly reduced serum NSE levels by day 7 and marked improvement in their GCS scores on day 3 of the study.

A comparative study of intravenous paracetamol and fentanyl for pain management in ICU.

Pain in ICU patients should be managed effectively and safely. Fentanyl and Paracetamol are used frequently in ICU. However experience using IV Paracetamol in the setting of critically ill patients is limited. We evaluated the analgesic effect and adverse reactions of intravenous Paracetamol compared to Fentanyl in ICU patients with mild to moderate pain. Forty patients in a general ICU were randomized into two groups of IV Paracetamol and IV Fentanyl in a single blinded fashion. Pain was assessed by Visual Analogue Scale (VAS) before drug administration and six hourly for 48 h of 1 g IV Paracetamol every 6 h for 48 h in the first group and 25 µg Fentanyl intravenously every three hours for 48 h in the second group. Patients were monitored for significant adverse reactions particularly of CNS and hepatic nature. Results showed the age, sex and pain score before analgesia was matched in both groups. Pain scores were similar in both groups at 24 h 2.60 (± 1.2) and 2.40 (± 1.5) and at 48 h 2.25 (± 0.96) and 2.05 (± 1.1) in Paracetamol and Fentanyl groups respectively. Clinical and laboratory adverse reactions were also similar in both groups. The analgesic properties of Paracetamol and Fentanyl were similar in this study. We did not observe any significant adverse effects in the two groups. Clinical and laboratory findings including liver functions remained without any statistically significant difference in two groups. This study demonstrates intravenous Paracetamol may be as safe and effective as Fentanyl in ICU patients with mild to moderate pain.