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.

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.

Demographic study of patients' mortality rate before and after the COVID-19 outbreak: A cross-sectional study.

Background and Aim: To better guide the health policies, it is essential to clarify the socio-demographic and clinical risk factors affecting the mortality rate of patients with coronavirus disease 2019 (COVID-19). Objective: The purpose of this project is to separate hospital mortality statistics into different groups, which will definitely help in planning to reduce the mortality rate. As well, we aimed to compare factors involved in COVID-19 death between the period before and after its outbreak. Methods: This cross-sectional study was performed based on all death certificates of archived records in Rasool Akram Hospital during the years 2018 and the first half of 2019. A checklist was completed based on the variables, including death cases by time, gender, age, duration of hospitalization, department of place and time of death, cause of death, cases referred to forensic medicine, information of the patient, including educational and occupational level and birth certificate issuing city, neonatal death, and IUFD, classification of diseases according to the provided version of ICD 10 (international classification of diseases 10th edition). Results: A number of 2632 deceased patients were included in this study, 1511 (57.4%) patients who died before the start of the COVID-19 outbreak, and 1121 (42.6%) patients died in the hospital after the start of this pandemic. There were statistically significant differences in gender (higher prevalence of males), increased average age, lower occupational status, decreased number of infants, increased cause of death due to COVID-19 and increased hospitalization in Royal ICU in dead patients (p < 0.05). Conclusion: The findings show that the elderly cases are more at risk of COVID-19 mortality than other age groups, which needs more attention to this group of society and clarifies other epidemiological factors, as well as clinicopathological and public healthcare practices.

Demographic Assessment of Burn Injuries in Iranian Patients.

Objective: This study investigated the demographic characteristics and factors influencing burn injuries, primarily in low socioeconomic societies where such incidents are prevalent due to factors such as illiteracy and poverty. Methods: This cross-sectional study included all burn patients admitted to Shahid Motahari Hospital in Tehran, Iran. Demographic data such as age, sex, occupation, education level, and residence as well as detailed information about the burn incidents such as date, time, location, number of people present at the scene, and referral place was collected. Additionally, comprehensive burn details such as cause, extent, severity, previous history, and need for hospitalization directly at the emergency department were documented. Results: The study included 2213 patients (mean age 34.98±19.41 years; range 1-96), with a men predominance (60.6%). The majority of burns (64.4%) occurred at home, primarily due to accidents (99.6%), with boiling water being the most common cause (39.2%). The most frequent burns were second-degree burns (91.8%), with an average injured body area of 6.31±6.67%. There were significant correlations between burn severity and demographic factors such as age, sex, occupation, cause of burn, hospital admission, outcome, and length of stay. Remarkably, the extent of burns was negatively correlated with the distance to the hospital, while positively correlated with the length of hospital stay. Conclusion: Burn injuries were significantly influenced by demographic factors. Enhancing treatment facilities and reducing the time and distance to medical care could be crucial in high-risk cases.

Effect of calcitriol supplementation on infectious biomarkers in patients with positive systemic inflammatory response: A Randomized Controlled Trial.

Background: Sepsis is one of the common causes of hospitalization of patients in intensive care units. A significant role for vitamin D in sepsis has been proposed, which is due to its active metabolite, calcitriol. Aims: Evaluate the effect of calcitriol supplementation on infectious biomarkers, including procalcitonin and presepsin. Methods: Patients with sepsis were divided into intervention and control group. Patients in the intervention group received intravenous calcitriol daily for 3 days. The serum levels of procalcitonin and presepsin were evaluated on days 0, 3, and 5 after administration. Results: Fifty-two SIRS-positive patients were evaluated. Baseline characteristics, changes in Sequential Organ Failure Assessment (SOFA) score and blood levels of vitamin D were not significantly different between the two groups. Procalcitonin levels on day 5 and the differences between day 5 and 0 were significantly lower in the intervention group (P = 0.02). Presepsin on the third and fifth days in the intervention group was reduced, but in the control group, there was an ascending trend. However, there was no significant difference between the two groups on days 3 and 5 (P = 0.17 and P = 0.06, respectively) or between days 3 as well as 5 and the baseline presepsin level (P = 0.93 and P = 0.92, respectively). The ICU length of stay and 28-day mortality did not differ significantly either between the two arms of the study. Conclusions: Finally, the results of this study showed that the administration of intravenous calcitriol could reduce the levels of procalcitonin but did not have a significant effect on presepsin.

Investigating the Effect of High-Dose Vitamin D3 Administration on Inflammatory Biomarkers in Patients with Moderate to Severe Traumatic Brain Injury: A Randomized Clinical Trial.

Background: Traumatic brain injury (TBI) is one of the most common neurological disorders worldwide. We aimed to investigate the efficacy of high-dose vitamin D3 on inflammatory biomarkers in patients with moderate to severe TBI. Methods: Thirty-five moderate to severe TBI patients were randomly assigned to intervention and control groups. Patients in the intervention group received a single intramuscular (IM) dose of 300,000 IU vitamin D. The primary endpoints were interleukin levels (IL-1ß and IL-6), and the secondary endpoints were changes in neutrophil to lymphocyte ratio (NLR), platelet to lymphocyte ratio (PLR), Glasgow Coma scale (GCS), and Glasgow Outcome Scale-Extended (GOS-E) scores compared between intervention and control arms of the study. The linear Generalized Estimating Equations were used for trend analysis and evaluating the association of independent factors to each outcome. Results: The results revealed a significant decrease in IL-1ß levels (-2.71±3.02, in the intervention group: P=0.001 vs. -0.14±3.70, in the control group: P=0.876) and IL-6 (-88.05±148.45, in the intervention group: P=0.0001 vs. -35.54±175.79, in the control groupL P=0.325) 3 days after the intervention. The improvement in the GCS score (P=0.001), reduction in NLR (P=0.001) and PLR (P=0.002), and improvement in the GOS-E score (P=0.039) was found to be greater in the vitamin D3 arm of the study than the control group. Conclusion: Administration of high-dose vitamin D3 in the acute phase of TBI could be effective in lowering the inflammatory markers and improving the level of consciousness and long-term performance outcomes.Trial Registration Number: IRCT20180522039777N2.

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 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.

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.

Effect of High-Dose Vitamin D on Duration of Mechanical Ventilation in ICU Patients.

The relationship of vitamin D3 with the duration of mechanical ventilation and mortality is still unknown. Therefore, this study aimed to determine the effect of using high-dose vitamin D on the duration of mechanical ventilation among the patients admitted to the intensive care unit. The current double-blinded clinical trial was performed on 44 mechanically ventilated, adult patients. Using permuted block randomization, the patients were recruited in intervention and placebo arms. In the placebo group, four patients were excluded due to death before 72 h. The vitamin D level was measured in both groups on entrance and 7th day of the study. The intervention and placebo groups received intramuscular injection of 300000 IU vitamin D and identical placebo, respectively. SOFA and CPIS score were evaluated daily for 7 days and on 14th and 28th days of the study. Also duration of mechanical ventilation and mortality rate were recorded. Fourteen males and 8 females were recruited in the intervention group, as well as 13 males and 5 females in the control group. There was no significant difference in baseline characteristics of the patients including gender and age. The mean duration of the mechanical ventilation was 17.63 ± 14 days in the intervention group versus 27.72 ± 22.48 days in the control group (p = 0.06). Mortality rate in control and intervention groups was 61.1% versus 36.3% (p = 0.00), respectively. Administration of high-dose vitamin D could reduce mortality in mechanically ventilated patients. Despite decrease of 10 days in duration of mechanical ventilation, the difference was not statistically significant. Larger studies are recommended.

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.

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.

Familiarity of Physicians and Nurses with Different Aspects of Oxygen Therapy; a Brief Report.

INTRODUCTION: Oxygen is a drug and physician and nurses should be familiar with the effects and potential risks of oxygen therapy. The current study aimed to assess familiarity of physicians and nurses with various aspects of oxygen therapy. METHOD: In this cross sectional study, the familiarity of physicians and nurses with various aspects of oxygen therapy in a teaching hospital was evaluated using a validated questionnaire. The collected data were analyzed using SPSS 21 software. RESULTS: 57 physicians and 79 nurses returned the completed questionnaire (response rate 97.1%). Mean clinical work experience of participants was 6.9±5.7 (1-15) years. 98.2% of physicians believed that oxygen therapy can be associated with risk and should be recorded in the patient's medical file. These measures were 92.4% and 98.2% for nurses. 38 (27.9%) participants correctly pointed out the reasons for oxygen therapy. Regarding necessary measurements and monitoring for oxygen therapy, 49 (86%) physicians and 65 (82.3%) nurses chose the correct answer. In addition, regarding necessity of blood gas analysis during oxygen therapy, 44 (77.2%) physicians and 55 (69.6%) nurses chose the correct answer. CONCLUSION: The findings showed that the familiarity level of participants with some aspects of O2 therapy such as its indications, necessary measurements and monitoring during therapy, and identifying delivery devices was fair to weak (<80%).

Once Versus Thrice Daily Colistin in Critically Ill Ptients with Multi-Drug Resistant Infections.

The aim of this study was to evaluate the procalcitonin (PCT) changes in two different high-dose colistin regimens in the treatment of multi-drug resistant MDR gram negative infections in ICU patients. This is a prospective study of adult ICU patients with bacteremia and ventilator associated pneumonia (VAP) caused by MDR gram negative pathogens. Patients were assigned to two colistin administration groups. Group A received 9 and group B received 3 million international units every 24 and 8 h respectively. Baseline characteristics and measurements of PCT concentrations at the start, the 3rd and the 5th day of the antibiotic therapy and their trends between the two groups were recorded and compared. of 40 patients enrolled, 34 completed the study protocol, of whom 30 (88.2%) had (VAP) and 4 (11.8%) had bacteremia. There were no statistically significant differences in the baseline characteristics between the two groups. The mean PCT levels in two study groups were; 2.34, 1.24, and 0.95 in group A and 5.89, 1.24 and 0.8 in group B at the baseline, 3rd and 5th day of colistin administration respectively (P=0.47). The ICU length of stay (LOS) in days and ICU mortality were; 31.31, 35.3% and 32.06, 22.2% in groups A and B (P=0.39, 0.87), respectively. CONCLUSION: We did not find any statistically significant differences in the serum PCT levels, ICU LOS or ICU mortality, between the two groups, who received maximum recommended dose of CMS with 2 different intervals of every 8 or 24 h.

A Randomized Placebo-controlled Trial of Clonidine Impact on Sedation of Mechanically Ventilated ICU Patients.

Clonidine has sedative and analgesic properties. Randomized studies examining these properties in mechanically ventilated ICU patients are scarce. This study was designed to assess the impact of clonidine on sedative agent use in mechanically ventilated patients. In a prospective, randomized, double blind, placebo-controlled study in a general ICU of a university medical center in Tehran, Iran, 40 patients, over 18 years on mechanical ventilation for 3 days or more randomized into 2 equal groups of clonidine and placebo. Clonidine arm received usual sedation and enteral clonidine 0.1 mg TID and escalated to 0.2 mg TID on the second day if hemodynamics remained stable. Ramsay Sedation Score was used to assess sedation. Opioids and midazolam were used in all patients. 10 patients in clonidine and 3 in placebo arms had history of drug abuse (P = 0.018). The mean of sedatives used in the clonidine/placebo arms (mg/day) were; MED (Morphine Equivalent Dose) 91.4 ± 97.9/112.1 ± 98.8 P=0.39, midazolam 7.1 ± 7.9/8.3 ± 9.2 P=0.66 and propofol 535.8 ± 866.7/139.1 ± 359.9 P=0.125. After adjusting for addiction and propofol, clonidine reduced MED use by 79.6 mg/day (P=0.005) and midazolam by 5.41 mg/day (P = 0.05). Opioids and midazolam need reduced by clonidine co-administration regardless of history of drug abuse. Acceptable side effect profile and the lower cost of clonidine could make it an attractive adjunct to sedative agents in ICU.

Study of the neuroprotective effects of memantine in patients with mild to moderate ischemic stroke.

Ischemic stroke is amongst the top four causes of mortality and the leading cause of disability in the world. The aim of this study was to evaluate the efficacy of a high dose memantine on neurological function of patients with ischemic stroke. In a randomized, 2 armed, open-label study, patients with mild to moderate cerebral thromboembolic event (CTEE) who admitted to Imam Hossein Hospital, Tehran, Iran, during preceding 24 hours, entered the study. Patients allocated in two study groups of memantine (as add-on therapy) and control. All patients were managed based on the American Heart Association and American Stroke Association (AHA/ASA) guidelines. Patients in memantine group received conventional treatment plus memantine 20 mg TID. The National Institute of Health Stroke Scale (NIHSS) was determined and recorded daily. The primary objective was comparison of the changes in NIHSS in the study groups at day 1 and day 5 of intervention. Significance level of p<0.05 was considered for statistical analysis. Patients were randomly allocated in control (15 women and 14 men, age 70.78 ± 10.92 years) and memantine (16 women and 8 men, age 73.33 ± 9.35 years) groups. There were no significant differences in age and sex distribution of two study groups as well as in comorbidities and concurrent drugs. NIHSS changes were significantly different between control (1.24 ± 0.96) and memantine group (2.96 ± 0.1), (p < 0.0001). Our results reveal that memantine added to standard treatment of CTEE could result in a remarkable decrease in the NIHSS confirming improvement of the neurological function of the patients.

Magnesium Sulfate in Exacerbations of COPD in Patients Admitted to Internal Medicine Ward.

The purpose of this study was to examine the effect of intravenous magnesium sulfate on patients with COPD exacerbation requiring hospitalization. In this randomized clinical trial 30 patients with COPD exacerbation were studied. Patients were randomly assigned to group A (case) who concurrent with standard therapy received 2 g magnesium sulfate in normal saline infused in 20 minutes on days one to three and group B (control) who received standard medications and placebo. PEFR and FEV1 were measured by before, 45 minutes and third day of entering the study. Vital signs HR, BP, RR, temperature and SpO2 were monitored during hospitalization. 21 males and 9 females patients with mean age of 68 ± 9 years, case 67 ± 10 and control 70 ± 8 were studied (15 patients in each arm of study). The mean pretreatment FEV1 was 26% ± 12, and 35% ± 18 in case and control groups respectively (P=0.137). FEV1 after 45 minutes in case group was 27% ± 9 and control group 36% ± 20 (p=0.122). FEV1 after 3 days of study was 32% ± 17 in case and 41% ± 22 in control groups (P=0.205). The mean pretreatment PEFR was 126 ± 76 l/min in case and 142 ± 62 l/min in control groups (P=0.46). Changes in PEFR were not significant 45 min (p=0.540) and 3 days (p=0.733) of the administration of intravenous magnesium sulfate. Duration of hospital stay between the two groups did not show any significant difference. This study showed that administration of intravenous magnesium sulfate in hospitalized patients with COPD exacerbation neither revealed any significant bronchodilating effect nor reduced duration of hospital stay.

Venous thromboembolism risk assessment, prophylaxis practices and interventions for its improvement (AVAIL-ME Extension Project, Iran).

BACKGROUND: Venous thromboembolism (VTE) is a major health issue worldwide. Data about VTE prophylaxis practices in developing countries are scarce. OBJECTIVES: The primary objectives of this survey were to define the VTE risk factors in hospitalized patients, to determine the rates of VTE prophylaxis administration and guideline compliance and to assess the effects of an educational program on VTE prophylaxis practices in Iran. PATIENTS AND METHODS: Data on 1219 patients from twenty hospitals in Iran were extracted from the AVAIL-ME Extension project main databank. VTE risks were categorized according to the Caprini Risk Assessment Model. Logistic regression analysis was carried out to assess factors influencing VTE prophylaxis. We also examined the impact of an educational program which consisted of awareness, risk assessment, internal protocol implementation and re-assessment, on VTE prophylaxis practices. RESULTS: Of 1219 patients, 789 (65%) and 430 (35%) were surgical and medical, respectively. VTE risks, categorized in low, moderate, high and very high were detected in 14%, 17%, 26% and 43% of patients respectively with a total of 1042(85%) patients being at risk for VTE. Of 882 (85%) eligible patients for VTE prophylaxis, 737 (83.5%) received any drug prophylaxis of whom 265 (62%) were medical and 472 (60%) were surgical. ACCP guidelines compliance was 60% and 33% in surgical and medical patients respectively. Any VTE prevention, drug prophylaxis, mechanical prophylaxis and guideline adherence were, 48% vs. 64%, 45% vs. 60%, 6% vs. 9% and 34% vs. 45% respectively (p<00.1) before and after implementation of the VTE educational program. CONCLUSIONS: Despite an overall improvement in VTE prevention, areas such as inappropriate use of VTE prophylaxis in a large number of patients, significant under-use of mechanical devices and guideline adherence require closer attention. VTE awareness education is beneficial in improving VTE prophylaxis in Iran.