Evaluation of the Efficacy and Safety of Intravenous Immunoglobulin (IVIG) in Moderate-to-Severe Hospitalized COVID-19 Patients: A Randomized, Open-Label Parallel-Group Study.

Purpose: Since February 2020, the world has been overwhelmed by the SARS-CoV-2 outbreak, and several patients suffered interstitial pneumonia and respiratory failure requiring mechanical ventilation, threatening the capability of healthcare systems to handle this amount of critical cases. Intravenous immunoglobulins (IVIG) possess potential immunomodulatory properties beneficial for COVID-19 patients, yet evidence supporting IVIG as adjunctive therapy remains sparse. This study evaluated the outcomes of adjunctive IVIG with the standard of care (SoC) in moderate-to-severe COVID-19 patients. Methods: This randomized study included 59 moderate-to-severe COVID-19 patients with known comorbidities. One arm (n = 33) received high-dose IVIG (400 mg/kg/day) within 48 hours for five days alongside SoC, while the other arm (n = 26) received SoC, comprising steroids, enoxaparin, and remdesivir. The primary endpoint was clinical improvement, as measured by the National Early Warning Score 2 (NEWS2) and discharged/death proportions. Secondary outcomes included IVIG safety, hospitalization duration, changes in oxygen saturation, inflammatory markers, IgG titer, CTSS (CT severity score), and radiological findings. Results: There was an improvement in the NEWS2 at the end of treatment in the IVIG arm (5.67 vs. 5.96). A significant absolute effect improvement (Day 1 vs. Day 9) was seen in serum LDH, D-dimer, hs-CRP, IL-6, CTSS, procalcitonin, respiratory rate, and chest radiographic findings. SARS-CoV-2 IgG titer increased significantly in the IVIG arm. There was a statistically significant reduction in mortality in the IVIG group (5 vs. 10). Conclusion: IVIG was a safe and effective adjunctive therapy to SoC treatment in moderate-to-severe COVID-19 patients needing ventilatory support. Furthermore, studies are required to validate our findings. This trial is registered with CTRI/2021/05/033622.

Mercury air, urine monitoring and health effects on occupationally exposed dental healthcare workers in Delhi, India.

BACKGROUND: Mercury (Hg) is a toxic heavy metal with multiple uses in various medical devices. Hg is used in dentistry as a restorative material. Such use creates significant exposure to dental practitioners. Hence, it is important to assess the risk created by Hg use in healthcare. OBJECTIVE: To quantify airborne Hg vapour exposure and Hg levels in dental healthcare workers, and determine the association of various symptoms and diseases to Hg exposure. METHODS: Air monitoring of Hg vapours were conducted in dental clinics and amalgam rooms. Urine samples were collected from occupationally exposed dental healthcare workers and urine Hg levels were measured. A cross-sectional health survey was conducted in 23 healthcare units of Delhi to determine an association between Hg exposure and various health effects. RESULTS: Hg vapour concentration ranged from 0.96µg/m3 to 15µg/m3, the highest concentration was recorded in the amalgam room (15µg/m3). Urine Hg levels in healthcare workers (0.51±0.17µg/L) were higher than the control (0.29±0.05µg/L). A cross-sectional health survey revealed a significant prevalence of confusion, forgetfulness, muscle spasm, and tremors by the respondents. CONCLUSION: Hg concentration in dental clinics may hover above the prescribed safe levels posing a definitive health risk to healthcare workers. Urinary Hg measurements did not reveal an excess of body burden except in one case. Since Hg bio accumulates, it is probable as these workers grow older, they may end up with a higher body burden of Hg that may lead to a variety of adverse health outcomes.

Clinical profile of hospitalised moderate category COVID-19 patients: Short study from a Tertiary Care Centre in Delhi.

Background: The clinical profile of hospitalized moderate-category COVID-19 patients has been understudied globally and in India. Aim: The present study was conducted to study the clinical profile and assess the proportions of patients who progressed to severe disease and its predictors among moderate COVID-19 patients. Materials and Methods: In this single-center observational study, 100 moderate-category COVID-19 patients as per Ministry of Health and Family Welfare (MoHFW) criteria of age ≥18 years of either sex, excluding pregnant females from February to November 2021, were studied by analyzing their clinical profiles and assessing Quick Sequential Organ Failure Assessment (qSOFA), National Early Warning Score 2 (NEWS-2), and chest computed-tomography severity score (CTSS) to predict progression to severe disease. Severe disease was defined as per MoHFW criteria. Results: Out of 100 moderate-category COVID-19 patients, progression to severe disease was seen in 11 patients (11%), among which eight patients had expired, three patients were discharged, and the rest of the 89 patients (89%) who did not progress to severe disease were discharged. A higher age (62.2± 19.5 vs 54.8 ± 14.6 years), along with multivariate analysis revealing male sex (1.25 times), chronic kidney disease (2.86 times), leukocytosis (6.10 times), thrombocytopenia (1.04 times), anemia (9.3 times), a higher qSOFA score (3.6 times), and a higher NEWS-2 score on admission (1.56 times) had higher odds of progression to severe disease. A significant correlation (P < .05) of qSOFA score with serum LDH, ferritin, and hs-CRP levels; CT severity score with the serum ferritin, IL-6, and LDH levels; and NEWS-2 with serum LDH, hs-CRP, and ferritin levels were found. Moreover, the NEWS-2 score was found slightly better than qSOFA on receiver operating characteristic (ROC) curve analysis, with an area under the curve of 85.8% and 83.2%, respectively, predicting progression to severe disease. Conclusion: Our study revealed male gender, chronic kidney disease, leukocytosis, anemia, thrombocytopenia, a higher qSOFA and NEWS-2 score on admission, and further, NEWS-2 score better than qSOFA on ROC curve analysis, with an area under the curve of 85.8% and 83.2%, respectively, in predicting severe disease among hospitalized moderate COVID-19 patients.

Systemic inflammatory response syndrome criteria (SIRS) and sepsis 3 criteria for assessing outcomes in sepsis: A prospective observational study.

Background: Sepsis is a major cause of death in hospitalised patients worldwide. Most studies for assessing outcomes in sepsis are from the western literature. Sparse data from Indian settings are available comparing the systemic inflammatory response syndrome (SIRS), Sequential Organ Failure Assessment (SOFA) and quick SOFA (qSOFA) (sepsis 3 criteria) for assessing outcomes in sepsis. In this study, we aimed to compare the SIRS criteria and sepsis 3 criteria to assess disease outcome at day 28 (recovery/mortality) in a North Indian tertiary care teaching hospital. Methods: A prospective observational study was performed in the Department of Medicine from 2019 to early 2020. Patients admitted to the medical emergency with clinical suspicion of sepsis were included. Systemic inflammatory response syndrome, qSOFA and SOFA scores were calculated at the time of presentation to the hospital. Patients were followed through the course of their hospital stay. Results: Out of 149 patients, 139 were included in the analysis. Patients who died had significantly higher mean SOFA, qSOFA scores and mean change in SOFA score than patients who survived (P value <0.01). There was no statistical difference between recovery and deaths at similar SIRS scores. A 40.30% fatality rate was recorded. Systemic inflammatory response syndrome had low Area Under Curve (AUC) (0.47) with low sensitivity (76.8) and specificity (21.7). SOFA had the maximum AUC (0.68) compared to qSOFA (0.63) and SIRS (0.47). SOFA also had the maximum sensitivity (98.1) while the qSOFA score had the maximum specificity (84.3). Conclusion: SOFA and qSOFA scores had superior predictive ability as compared to the SIRS score in assessing mortality in sepsis patients.

Can Sublingual Nitrate Improve Visualization of Lower Limb Arteries on Computed Tomography Angiography?

OBJECTIVE: The aim of the study is to evaluate the role of sublingual nitrate in improving vessel visualization on peripheral computed tomography angiography (CTA). METHODS: Fifty patients clinically diagnosed with peripheral arterial disease of the lower limb were prospectively included in this study: Twenty-five underwent CTA after sublingual nitrate administration (nitrate group) and 25 without (non-nitrate group). Two blinded observers qualitatively and quantitatively assessed the data thus generated. The mean luminal diameter, intraluminal attenuation, site, and percentage of stenosis were evaluated in all segments. Assessment of collateral visualization at sites of significant stenosis was also done. RESULTS: Patients in the nitrate and non-nitrate groups were similar in age and sex characteristics ( P > 0.05).On subjective evaluation, there was significantly improved visualization of the femoropopliteal and tibioperoneal vasculature of the lower limb in the nitrate group compared with the non-nitrate group ( P < 0.05). Quantitative evaluation showed a statistically significant difference in the measured arterial diameters for all evaluated segments in the nitrate group versus the non-nitrate group ( P < 0.05). Intra-arterial attenuation was significantly greater for all segments in the nitrate group resulting in better contrast opacification in these studies. Collateral visualization around segments with more than 50% stenosis/occlusion was also better in the nitrate group. CONCLUSIONS: Our study suggests that nitrate administration before peripheral vascular CTA can improve visualization, especially in the distal segments by increasing the vessel diameter and intraluminal attenuation along with better delineation of the collateral circulation around stenotic areas. It may also improve the number of evaluable segments of vasculature in these angiographic studies.

Human Health Risk Assessment due to Heavy Metals in Ground and Surface Water and Association of Diseases With Drinking Water Sources: A Study From Maharashtra, India.

Background: Contamination of freshwater sources can be caused by both anthropogenic and natural processes. According to Central Pollution Control Board, Maharashtra along with 2 other states, contribute 80% of hazardous waste generated in India, including heavy metal pollution. Hence, it is important to quantify heavy metal concentrations in drinking water sources in such areas. Materials and methods: Water samples were analyzed for toxic elements (F, As, Cd, Hg, Pb, Ni, Cu, Zn, Mn, and Cr) using Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) Agilent 7500. Health risks due to ingestion and dermal contact was assessed. A total of 557 people were randomly selected, with consumers from all 4 types of water sources that is surface water, hand pump, wells, and municipal water. Spot urine samples were collected from 47 people after considering inclusion and exclusion criteria. Urine was collected for estimating mercury and arsenic levels in the study participants. Results: Arsenic contributes the most health risk from ingestion from water. Among surface water users, 14 people (32%) reported frequent loose stool (P-value < .05) (OR 2.5), and 11 people (23%) reported frequent abdominal pain (OR 1.9). Hand pump and well water users reported frequent abdominal pain (27%) (OR 1.4) and gastric discomfort (31%) (P-value < .05) (OR 3) respectively. The mean value of urinary Hg and As were 4.91 ± 0.280 and 42.04 ± 2.635 µg/L respectively. Conclusion: Frequent loose stool, gastric discomfort, and frequent abdominal pain were associated with the various sources of drinking water. Urine Hg levels were found higher than the NHANES (USA) Survey. It is recommended that frequent monitoring of drinking water should be enforced around the industrial hub, so that appropriate actions can be taken if present in excess.

Role of cardiovascular magnetic resonance imaging in COVID-19 recovered patients: A short-term follow-up study.

OBJECTIVE: Cardiac involvement in recovered COVID-19 patients assessed by cardiac magnetic resonance imaging (MRI). METHODS: Subjects recently recovered from COVID-19 and with an abnormal left ventricular global longitudinal strain were enrolled. Cardiac MRI in all the enrolled subjects was done at baseline (within 30-90 days following recovery from COVID-19) with a follow-up scan at 6 months in individuals with an abnormal baseline scan. Additionally, 20 age-and sex-matched individuals were enrolled as healthy controls (HCs). RESULTS: All the 30 enrolled subjects were symptomatic during active COVID-19 disease and were categorized as mild: 11 (36.7%), moderate: 6 (20%), and severe: 13 (43.3%). Of the 30 patients, 16 (53.3%) had abnormal CMR findings. Myocardial edema was reported in 12 (40%) patients while 10 (33.3%) had late gadolinium enhancement (LGE). No difference was observed in terms of conventional left ventricular (LV) parameters; however, COVID-19-recovered patients had significantly lower right ventricular (RV) ejection fraction, RV stroke volume, and RV cardiac index compared to HCs. Follow-up scan was abnormal in 4/16 (25%) with LGE persisting in three patients (who had severe COVID-19 [3/4;75%]). Subjects with severe COVID-19 had a greater frequency of LGE (53.8%) and myocardial edema (61.5%) as compared to mild and moderate cases. Myocardial T1 (1284 ± 43.8 ms vs. 1147.6 ± 68.4 ms; p < .0001) and T2 values (50.8 ± 16.7 ms vs. 42.6 ± 3.6 ms; p = .04) were significantly higher in post COVID-19 subjects compared to HCs. Similarly, T1 and T2 values of severe COVID-19 patients were significantly higher compared to mild and moderate cases. CONCLUSIONS: An abnormal CMR was seen in half of the recovered patients with persistent abnormality in one-fourth at 6 months. Our study suggests a need for closer follow-up among recovered subjects in order to evaluate for long-term cardiovascular sequelae. COVID-19 causes structural changes in the myocardium in a small segment of patients with partial spontaneous resolution.

Heavy Metal Accumulation in Fruits and Vegetables and Human Health Risk Assessment: Findings From Maharashtra, India.

background: Vegetables are consumed enormously by humans all over the world. Consumption of contaminated fruits and vegetables is the most likely route of heavy metal exposure. Hence, it is important to quantify heavy metal concentration in frequently consumed fruits and vegetables. materials and methods: The main aim of our study is to investigate heavy metal (Pb, Cd, As, and Hg) contamination in 24 different kinds of vegetables and fruits grown in the industrialized city of Solapur, Maharashtra, India. Potential health risks due to the consumption of fruits and vegetables were assessed. Heavy metal concentration and quality of native soil were also determined. Vegetable and fruit samples were analyzed using Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) Agilent 7500. results: The mean concentrations of selected heavy metals in fruits and vegetables analyzed were: Lead (0.17 ± 0.38 mg/kg) > Mercury (0.06 ± 0.09 mg/kg) > Cadmium (0.02 ± 0.007 mg/kg) > Arsenic (0.002 ± 0.003 mg/kg). Among them, garlic showed the highest heavy metal accumulation followed by potato. conclusion: Overall, vegetables showed higher metal accumulations than fruits. Some vegetables showed alarming levels of human health risk indices such as the Metal Pollution Index (MPI), Health Risk Index (HRI) and Hazard Index (HI), suggesting that reducing the intake amount of these vegetables may lower the adverse health effects.

Effect of Supplementation of Vitamin C and Thiamine on the Outcome in Sepsis: South East Asian Region.

INTRODUCTION: The global burden of sepsis is overwhelming and novel therapeutic agents is the need of the hour. The present study was designed to understand the role of Malondialdehyde as a marker of the oxidative stress in sepsis, as well as the effect of supplementation of Vitamin C and Thiamine in patients of sepsis. METHODS: 80 patients of sepsis were randomly divided into 4 groups of 20 each. Twenty age-sex matched healthy volunteers were chosen as controls. The first group received Vitamin C, the second group received Thiamine, the third group received both and the fourth group received neither. Vitamin C (2g 8 hourly) and Thiamine (200 mg 12 hourly) were given intravenously for five days. The outcome was recorded in terms of mortality in the various groups as well as by the improvement in SOFA scores (ΔSOFA). The serum levels of Vitamin C, Thiamine and Malondialdehyde were estimated. RESULTS: Among the 80 patients, 17 (21%) were in septic shock. The mortality rate was 10% overall, and 47% among patients of septic shock. No additional mortality benefit was observed in the groups supplemented with Vitamin C and Thiamine. However, the ΔSOFA score in patients who received both Vitamin C and Thiamine was significantly higher as compared to the other groups. The mean malondialdehyde level was higher in patients of sepsis (1.81±1.18 µmol/l) as compared with healthy controls (0.78 ± 0.36 µmol/l). The Vitamin C level and Thiamine level (estimated indirectly by TPP effect), at presentation were 5.14±4.19 ng/ml and 52.99±28.45 % in patients of sepsis, which was significantly lower than that in healthy controls, in whom the levels were 14.64±5.51 ng/ml and 27.55±13.67% respectively. CONCLUSION: Vitamin C and Thiamine supplementation is a cost-effective approach with a good safety profile. Additional studies including a larger population is required to study the mortality benefits and reaffirm our findings.

A case report on uneventful anticoagulation and persistence of Type 1 Respiratory Failure post severe COVID-19 infection in a patient of Osler-Weber-Rendu syndrome.

The SARS-CoV-2 pandemic has led researchers worldwide to study the patterns of association of SARS-CoV-2 with different diseases, which have been a prime focus of medical literature. Osler-Weber-Rendu syndrome, also known as hereditary hemorrhagic telangiectasia (HHT), is a rare genetic disorder in which patients present with recurrent epistaxis, nostril manipulations, and multiple arteriovenous malformations (AVMs) along with telangiectasias involving internal organs and mucocutaneous areas. In addition, these AVMs are prone to bleeding or act as a nidus for thrombus formation, apart from other serious complications, such as chronic hypoxemia, anemia, pulmonary artery hypertension, heart failure, and cerebrovascular accidents. Here, we present a case report of a patient who presented with acute onset respiratory complaints, had multiple episodes of epistaxis in the past, and was later diagnosed with HHT as per Curaçao criteria in our hospital. Doppler ultrasound over the left calf region showed an AVM. Contrast-enhanced computed tomography (CECT) angiography of the chest and abdomen revealed multiple pulmonary and hepatic AVMs along with splenic and uterine telangiectasias and malformations, who on acquiring severe COVID-19 infection developed complications such as anemia, pulmonary artery hypertension, sepsis, acute kidney injury, and post-COVID-19 persistence of Type 1 respiratory failure. Furthermore, the risk-benefit ratio of anticoagulation therapy in such patients with COVID-19 infection is tricky and challenging. However, our patient was prophylactically anti-coagulated with enoxaparin for 12 days with an uneventful outcome.

Sewer gas poisoning causing transient and focal ST-segment elevation in the ECG: Case report.

In India, a large number of sanitary care workers are involved in manual scavenging. This exposes them to sewer gas mainly consisting of hydrogen sulphide. Sewer gas toxicity primarily causes neurological injury, followed by cardiac and respiratory involvement. A few cases of diffuse ST-segment elevation in the electrocardiogram (ECG) following hydrogen sulphide poisoning are known in the literature. Here, we report a case of acute sewer gas poisoning in a 45-year-old man with transient and focal ST-segment elevation in the anteroseptal leads of the ECG mimicking acute anterior wall myocardial infarction.

Expert Consensus Statements on the Use of Corticosteroids in Non-severe COVID-19.

INTRODUCTION: There is strong evidence for the use of corticosteroid in the management of severe coronavirus disease-2019 (COVID-19). However, there is still uncertainty about the timing of corticosteroids. We undertook a modified Delphi study to develop expert consensus statements on the early identification of a subset of patients from non-severe COVID-19 who may benefit from using corticosteroids. METHODS: A modified Delphi was conducted with two anonymous surveys between April 30, 2021, and May 3, 2021. An expert panel of 35 experts was selected and invited to participate through e-mail. The consensus was defined as >70% votes in multiple-choice questions (MCQ) on Likert-scale type statements, while strong consensus as >90% votes in MCQ or >50% votes for "very important" on Likert-scale questions in the final round. RESULTS: Twenty experts completed two rounds of the survey. There was strong consensus for the increased work of breathing (95%), a positive six-minute walk test (90%), thorax computed tomography severity score of >14/25 (85%), new-onset organ dysfunction (using clinical or biochemical criteria) (80%), and C-reactive protein >5 times the upper limit of normal (70%) as the criteria for patients' selection. The experts recommended using oral or intravenous (IV) low-dose corticosteroids (the equivalent of 6 mg/day dexamethasone) for 5-10 days and monitoring of oxygen saturation, body temperature, clinical scoring system, blood sugar, and inflammatory markers for any "red-flag" signs. CONCLUSION: The experts recommended against indiscriminate use of corticosteroids in mild to moderate COVID-19 without the signs of clinical worsening. Oral or IV low-dose corticosteroids (the equivalent of 6 mg/day dexamethasone) for 5-10 days are recommended for patients with features of disease progression based on clinical, biochemical, or radiological criteria after 5 days from symptom onset under close monitoring. HOW TO CITE THIS ARTICLE: How to cite this article: Nasa P, Chaudhry D, Govil D, Daga MK, Jain R, Chhallani AA, et al. Expert Consensus Statements on the Use of Corticosteroids in Non-severe COVID-19. Indian J Crit Care Med 2021;25(11):1280-1285.

Massive hemoptysis causing mortality in a post COVID-19 infected Asian male patient: Presenting as pulmonary mucormycosis, pulmonary tuberculosis and later sino-nasal mucormycosis.

While the developed nations are discussing giving a third dose of the COVID-19 vaccine to immunocompromised individuals, there are still challenges that are of global concern, especially in developing countries. The Delta variant which is predominantly responsible for the disease burden has now been reported in over 148 countries. The catastrophe caused in the Indian subcontinent has highlighted some associations, most notable being the unprecedented rise in the cases of mucormycosis in COVID-19 patients referred to as CAM (COVID-19 associated mucormycosis). This life-threatening opportunistic fungal infection which was historically associated with immunosuppression has reached a new peak as its incidence has increased many folds with the advent of COVID-19. Here we present one of the very first Case reports on how to post COVID immunosuppression state, uncontrolled blood sugar levels in the background of diabetic ketoacidosis led to the development of pulmonary mucormycosis with superimposed pulmonary tuberculosis and later Sino-nasal mucormycosis eventually leading to life-threatening massive hemoptysis, causing mortality of a post-COVID-19 infected middle-aged diabetic Asian male patient who presented twenty days after COVID-19 infection. However, our patient did not have risk factors such as severe COVID-19 infection requiring hospitalization, use of steroids or other immunomodulatory drugs like remdesivir or tocilizumab. Our case report aims to bring forth this post COVID pulmonary mucormycosis with pulmonary tuberculosis association as well as highlight the fact that tuberculosis is still a major public health burden that should not be forgotten in the fight to combat the pandemic.

Leishmaniasis.

Leishmaniasis is one of the chronic debilitating vector-borne diseases caused by obligate intracellular protozoa. The global burden of disease although not increasing but potential risk of spread is there. At least 20 species of Leishmania are pathogenic to human beings. The transmission is from female sandfly through a blood meal. The disease pathogenesis is dependent on parasite and host mechanism-primarily cell-mediated immunity. The three common forms are visceral, cutaneous, and mucocutaneous. The diagnostic tests are mainly based on aspiration from the spleen or bone marrow. The use of K39 antibodies is the best serodiagnostic test. Antimonial, amphotericin B, miltefosine, and paromomycin are the drugs used to treat leishmaniasis. Amphotericin therapy shows the response within 7 to 10 days in most subjects, and 2 weeks of therapy is sufficient. However, those going into relapse need new treatment regimes. There is a definite benefit of combination therapy. However, there is still no breakthrough on a vaccine for prophylaxis. How to cite this article: Daga MK, Rohatgi I, Mishra R. Leishmaniasis. Indian J Crit Care Med 2021;25(Suppl 2):S166-S170.

Lactate enhanced-quick Sequential Organ Failure Assessment 2 (LqSOFA2): A new score for bedside prognostication of patients with sepsis.

Background & objectives: Early diagnosis and prompt treatment remain a challenge in sepsis. To study the role of quick Sequential Organ Failure Assessment (qSOFA), blood lactate levels and a new score Lactate - Enhanced-qSOFA 2 (LqSOFA2) in predicting outcome in patients with sepsis and their association with established severity scores. Methods: This was a prospective, observational study in patients admitted to ICU of a tertiary care hospital in north India. qSOFA, Acute Physiology and Chronic Health Evaluation II (APACHE II), SOFA score and LqSOFA2 were calculated in 150 patients with sepsis. Measurements of lactate and SOFA score was done on days one, three and seven. Results: The mean arterial pressure (MAP) was significantly higher in survivors (70.14±19.54 vs. 48.53±26.86). The mean qSOFA significantly predicted mortality (1.81 vs. 2.63; P<0.0001). The mean lactate on days one, three and seven in survivors were 2.27±0.91, 1.72±0.77 and 1.14±0.48, respectively, while it was 4.32±2.35, 3.57±2.28 and 2.13±1.22, respectively, in the non-survivor group (P<0.001). The new score LqSOFA2 also significantly predicted mortality between non survivors and survivors (3.52±0.71 vs. 2.37±0.91). There was a significant correlation of qSOFA with SOFA and APACHE II on day one. Lactate levels and SOFA correlated on all three days. Interpretation & conclusions: qSOFA, a novel score and lactate can independently predict mortality in patients with sepsis. They correlate with APACHE II and SOFA but fail to equilibrate with either. The combination score LqSOFA2 showed marginal (statistically insignificant) increase in predictive accuracy and specificity when compared to lactate or qSOFA alone. Early diagnosis by LqSOFA2 makes it a good standalone bedside prognostic marker.

Drug utilization, rationality, and cost analysis of antimicrobial medicines in a tertiary care teaching hospital of Northern India: A prospective, observational study.

BACKGROUND: The burden of bacterial infections is huge and grossly under-represented in the current health-care system. Inappropriate use of antimicrobial medicines (AMMs) poses a potential hazard to patients by causing antibiotic resistance. This study was conducted to assess the: (i) AMM consumption and use patterns in patients attending the outpatients and inpatients of Medicine and Surgery departments of the hospital. (ii) Appropriateness of the AMM in the treatment prescribed, and (iii) cost incurred on their use in admitted patients. MATERIALS AND METHODS: An observational, prospective study was conducted among inpatients and outpatients of the Medicine and Surgery departments of a tertiary care hospital of northern India. Analysis of 2128 prescriptions and 200 inpatient records was performed using a predesigned format. The use of AMMs was reviewed using anatomical therapeutic chemical classification and defined daily doses (DDDs). To evaluate the expenditure incurred on AMMs, ABC analysis was performed. RESULTS: AMMs were prescribed to 37.9% outpatients and 73% of admitted patients. The percentage encounters with AMMs was 40.6% (medicine) and 25.6% (surgery) outpatients. The total DDDs/100 patient days of AMMs in medicine and surgery were 3369 and 2247. Bacteriological evidence of infection and AMM sensitivity was present in only 8.5% of cases. Over 90% of AMMs were prescribed from the hospital essential medicines list. Most of the AMMs were administered parenterally (64.9%). Multiple AMMs were prescribed more to inpatients (84.2% vs. 4.2% outpatients). Overall, expenditure on AMM was 33% of the total cost of treatment on medicine. ABC analysis showed that 74% of the expenditure was due to newer, expensive AMM, which constituted only 9% of the AMM used. The AMM therapy was found to be appropriate in 88% of cases as per Kunin's criteria for rationality. CONCLUSION: AMMs are being commonly prescribed without confirmation of AMM sensitivity in the hospital. A large proportion of expenditure is being incurred on expensive AMM used in a few number of patients. There is a need for developing a policy for rational use of AMM in the health facility.

Critical care practice in India: Results of the intensive care unit need assessment survey (ININ2018).

BACKGROUND: A diverse country like India may have variable intensive care units (ICUs) practices at state and city levels. AIM: To gain insight into clinical services and processes of care in ICUs in India, this would help plan for potential educational and quality improvement interventions. METHODS: The Indian ICU needs assessment research group of diverse-skilled individuals was formed. A pan- India survey "Indian National ICU Needs" assessment (ININ 2018-I) was designed on google forms and deployed from July 23rd-August 25th, 2018. The survey was sent to select distribution lists of ICU providers from all 29 states and 7 union territories (UTs). In addition to emails and phone calls, social medial applications-WhatsApp™, Facebook™ and LinkedIn™ were used to remind and motivate providers. By completing and submitting the survey, providers gave their consent for research purposes. This study was deemed eligible for category-2 Institutional Review Board exempt status. RESULTS: There were total 134 adult/adult-pediatrics ICU responses from 24 (83% out of 29) states, and two (28% out of 7) UTs in 61 cities. They had median (IQR) 16 (10-25) beds and most, were mixed medical-surgical, 111(83%), with 108(81%) being adult-only ICUs. Representative responders were young, median (IQR), 38 (32-44) years age and majority, n = 108 (81%) were males. The consultants were, n = 101 (75%). A total of 77 (57%) reported to have 24 h in-house intensivist. A total of 68 (51%) ICUs reported to have either 2:1 or 2≥:1 patient:nurse ratio. More than 80% of the ICUs were open, and mixed type. Protocols followed regularly by the ICUs included sepsis care, ventilator- associated pneumonia (83% each); nutrition (82%), deep vein thrombosis prophylaxis (87%), stress ulcer prophylaxis (88%) and glycemic control (92%). Digital infrastructure was found to be poor, with only 46 % of the ICUs reporting high-speed internet availability. CONCLUSION: In this large, national, semi-structured, need-assessment survey, the need for improved manpower including; in-house intensivists, and decreasing patient-to-nurse ratios was evident. Sepsis was the most common diagnosis and quality and research initiatives to decrease sepsis mortality and ICU length of stay could be prioritized. Additionally, subsequent surveys can focus on digital infrastructure for standardized care and efficient resource utilization and enhancing compliance with existing protocols.

Adrenomedullin and Its Possible Role in Improved Survival in Female Patients with Sepsis: A Study in the South East Asian Region.

AIMS AND OBJECTIVES: Serum adrenomedullin (ADM) as a prognostic biomarker to study the gender-related differences in mortality pattern and its correlation with the sequential organ failure assessment (SOFA) and acute physiologic assessment and chronic health evaluation II (APACHE II) scores in patients of sepsis. MEASUREMENTS AND MAIN RESULTS: Eighty patients of sepsis of which 36 were males and 44 were females, were taken in the study as per sepsis III guidelines. They were followed up for a period of 28 days. Serum ADM was measured on day 1 and day 5. The endpoint was mortality or survival at day 28 after admission. The death rate among males was higher, with 23 of the total 36 (63.89%) patients having died when compared with females in which 25 patients out of 44 (56.82%) had died. The observed mortality rates correlated well with average APACHE II scores. The average APACHE II score was slightly higher in males (29 ± 8.97) when compared with females (27.02 ± 8.69). Similarly, day 1 SOFA and mean SOFA values were higher in males (10.22 ± 5.36) and (10.73 ± 6.01) when compared with females (8.27 ± 4.79) and (8.89 ± 5.6), respectively. Males despite having higher mortality rates, higher APACHE II, SOFA, and mean SOFA values were still having less mean levels of serum ADM (454.40 ± 81.13 pg/mL) when compared with females (479.62 ± 126.97 pg/mL). CONCLUSION: Adrenomedullin is a protective neurohormone with antibacterial and anti-inflammatory properties. It is elevated in all patients with sepsis but the rise is more so in the female when compared with males. Higher ADM levels in females may suggest the protective effect of ADM as a part of the general protective neurohormonal stress response, which may explain the low death rate in females in sepsis. HOW TO CITE THIS ARTICLE: Daga MK, Kumar L, Mawari G, Kumar N, Singh S, Mishra TK. Adrenomedullin and Its Possible Role in Improved Survival in Female Patients with Sepsis: A Study in the South East Asian Region. Indian J Crit Care Med 2020;24(12):1180-1184.

Effect of a Recombinant Human Soluble Thrombomodulin on Mortality in Patients With Sepsis-Associated Coagulopathy: The SCARLET Randomized Clinical Trial.

Importance: Previous research suggested that soluble human recombinant thrombomodulin may reduce mortality among patients with sepsis-associated coagulopathy. Objective: To determine the effect of human recombinant thrombomodulin vs placebo on 28-day all-cause mortality among patients with sepsis-associated coagulopathy. Design, Setting, and Participants: The SCARLET trial was a randomized, double-blind, placebo-controlled, multinational, multicenter phase 3 study conducted in intensive care units at 159 sites in 26 countries. All adult patients admitted to one of the participating intensive care units between October 2012 and March 2018 with sepsis-associated coagulopathy and concomitant cardiovascular and/or respiratory failure, defined as an international normalized ratio greater than 1.40 without other known etiology and a platelet count in the range of 30 to 150 × 109/L or a greater than 30% decrease in platelet count within 24 hours, were considered for inclusion. The final date of follow-up was February 28, 2019. Interventions: Patients with sepsis-associated coagulopathy were randomized and treated with an intravenous bolus or a 15-minute infusion of thrombomodulin (0.06 mg/kg/d [maximum, 6 mg/d]; n = 395) or matching placebo (n = 405) once daily for 6 days. Main Outcome and Measures: The primary end point was 28-day all-cause mortality. Results: Among 816 randomized patients, 800 (mean age, 60.7 years; 437 [54.6%] men) completed the study and were included in the full analysis set. In these patients, the 28-day all-cause mortality rate was not statistically significantly different between the thrombomodulin group and the placebo group (106 of 395 patients [26.8%] vs 119 of 405 patients [29.4%], respectively; P = .32). The absolute risk difference was 2.55% (95% CI, -3.68% to 8.77%). The incidence of serious major bleeding adverse events (defined as any intracranial hemorrhage; life-threatening bleeding; or bleeding event classified as serious by the investigator, with administration of at least 1440 mL [typically 6 units] of packed red blood cells over 2 consecutive days) was 23 of 396 patients (5.8%) in the thrombomodulin group and 16 of 404 (4.0%) in the placebo group. Conclusions and Relevance: Among patients with sepsis-associated coagulopathy, administration of a human recombinant thrombomodulin, compared with placebo, did not significantly reduce 28-day all-cause mortality. Trial Registration: ClinicalTrials.gov Identifier: NCT01598831.

Role of oestrogen and its receptors in HEV-associated feto-maternal outcomes.

BACKGROUND: Pregnant women infected with HEV develops adverse pregnancy outcomes like, abortions, intrauterine fetal death, still births, neonatal deaths, preterm delivery and maternal mortality. AIM: To correlate oestrogen and its receptors ESR1α and ESR2ß levels with HEV-associated feto-maternal outcomes. MATERIAL & METHODS: A total of 142 pregnant women with HEV infection and 142 pregnant controls were included in study from Department of Obstetrics & Gynaecology and Department of Medicine, Maulana Azad Medical College (MAMC) and associated Lok Nayak Hospital (LNH), New Delhi. Three millilitre of blood sample was collected in plain for quantification of oestrogen, and its receptors ESR1α and ESR2ß using commercially available third-generation ELISA kits. RESULTS: The levels of oestrogen, ESR1α and ESR2ß were considerably higher in HEV-infected pregnant women (20.11 ± 18.19 ng/mL, 10.58 ± 3.27 ng/mL, 10.42 ± 4.71 ng/mL respectively) than pregnant controls (11.74 ± 6.42 ng/mL, 9.11 ± 1.63 ng/mL, 9.01 ± 1.18 ng/mL respectively)(P < 0.0001). It was found that oestrogen levels were significantly higher in pregnant women infected with HEV who had preterm delivery, low birth weight babies and fetal loss (19.64 ± 17.60 ng/mL, 19.71 ± 17.63 ng/mL, 33.62 ± 23.20 ng/mL respectively) than who had full term delivery, average birth weight babies and live babies (11.71 ± 8.77 ng/mL, 11.99 ± 9.44 ng/mL, 16.58 ± 14.98 ng/mL respectively)(P < 0.05). A significant negative correlation was observed between baby birth weight and oestrogen levels in HEV-infected pregnant women. CONCLUSION: The high level of oestrogen plays an important role in preterm delivery, low birth weight babies and fetal mortality in pregnant women with HEV infection through placental dysfunction. Moreover, oestrogen level is a significant predictor for preterm delivery and maternal mortality and ESR2ß levels is a significant predictor for maternal mortality in pregnant women infected with HEV.