Clinical Characteristics and Outcomes of COVID-19 Patients Hospitalized in Intensive Care Unit.

BACKGROUND: Meta-analysis and clinical studies suggest coronavirus disease-2019 (COVID-19) patients in ICU have a high mortality rate of 30-45%, which has evolved as a function of criteria of admission and the management modalities. MATERIALS AND METHODS: We conducted a retrospective evaluation for characteristics and outcomes in critical care set up across six months. RESULTS: 514 patients (74.3% males and 25.6% females) were evaluated. 9.72% (n = 50) patients expired, 78% (n = 39) were males. Mean age (years) was 57 (±14, range 64, 95% CI 55-58). 65.7% (n = 338) were of age more than 50 years, of which 71.5% (n = 242) were males. Males at 20% higher risk for death than women. (RR = 1.2, 95% CI 0.66-2.31, p = 0.61 NS). There was 18% less risk of mortality in female vs male with comorbidities (RR 0.82, 95% CI 0.67-1.12, p = 0.32 NS). Risk for mortality in diabetics was significantly increased by 116% vs nondiabetics. (RR 2.16, p = 0.0055, 95% CI 1.28-3.67). Highly significant risk of mortality in age group >50 years (3.13 times higher) vs age ≤50 years. (RR 3.18, 95% CI 1.71-8.64, p = 0.0003). 50.2% had moderate ARDS at admission. High flow nasal cannula was used in 47.2%. There is 5.79 times more likelihood to be on the ventilator with moderate to severe ARDS vs mild ARDS (RR = 5.79, 95% CI 3.10-11.05, p <0.0001). Risk for death was six times higher for patients on ventilator vs not on ventilator (RR = 6.08, 95% CI 3.49-10.59, p <0.0001). The mean number of days on ventilator for patients who underwent tracheostomy (n = 49) was 14 days as compared to 6.6 days in patients who were extubated (n = 57) (p <0.0001). P/F ratio had negative correlation with number of days of hospitalisation (Pearson r -0.391, 95% CI -0.46- -0.31, p <0.0001). 67% less chances of mortality in patients on steroids (RR = 0.33, 95% CI 0.19-60, p = 0.0012). Mean duration of ICU stay (days) was 8 (± 5, range 29, 95% CI 7.5-8.4). CONCLUSIONS: We observed that a strict adherence to the basic principles of ARDS management resulted in a lower mortality in ICU setting. HOW TO CITE THIS ARTICLE: Pandit RA, Gagana BN, Vaity C, Mulakavalupil B, Choudhary JS, Jain V, et al. Clinical Characteristics and Outcomes of COVID-19 Patients Hospitalized in Intensive Care Unit. Indian J Crit Care Med 2021;25(9):992-1000.

Pre-clinical evaluation of an innovative oral nano-formulation of baicalein for modulation of radiation responses.

There is an unmet medical need for non-toxic and effective radiation countermeasures for prevention of radiation toxicity during planned exposures. We have earlier shown that intraperitoneal administration of baicalein (BCL) offers significant survival benefit in animal model. Safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of baicalein has been reported in pre-clinical model systems and also in healthy human volunteers. However, clinical translation of baicalein is hindered owing to poor bioavailability due to lipophilicity. In view of this, we fabricated and characterized in-situ solid lipid nanoparticles of baicalein (SLNB) with effective drug entrapment and release kinetics. SLNB offered significant protection to murine splenic lymphocytes against 4 Gy ionizing radiation (IR) induced apoptosis. Oral administration of SLNB exhibited ~70% protection to mice against whole body irradiation (WBI 7.5 Gy) induced mortality. Oral relative bioavailability of BCL was enhanced by over ~300% after entrapment in the SLNB as compared to BCL. Oral dosing of SLNB resulted in transient increase in neutrophil abundance in peripheral blood. Interestingly, we observed that treatment of human lung cancer cells (A549) with radioprotective dose of SLNB exhibited radio-sensitization as evinced by decrease in survival and clonogenic potential. Contrary to antioxidant nature of baicalein in normal cells, SLNB treatment induced significant increase in cellular ROS levels in A549 cells probably due to higher uptake and inhibition of TrxR. Thus, a pharmaceutically acceptable SLNB exhibited improved bioavailability, better radioprotection to normal cells and sensitized cancer cells to radiation induced killing as compared to BCL suggesting its possible utility as an adjuvant during cancer radiotherapy.

Off-label drugs use in neurology outpatient department: A prospective study at a tertiary care teaching hospital.

BACKGROUND: Off-label drug use refers to any use of an approved or cleared drug that is not included in that product's approved labeling or cleared indications for use. It may be in terms of indication, age group, dosage, or route of administration. Off-label drug prescriptions are common neurology practice. AIM: The aim of the study is to evaluate the prevalence pattern of off-label drug use in neurology. SUBJECTS AND METHODS: A prospective, observational, cross-sectional study was carried out in the neurology outpatient department of tertiary care teaching hospital. Data of patients above 18 years were recorded after obtaining their informed consent. The National Formulary of India (NFI) and British National Formulary (BNF) guidelines were used as tools for evaluation of the prevalence of off-label drug use. RESULTS: A total of 709 drugs were recorded from the prescription data of 205 patients collected in the duration of 2 months. The results reported 145 (20.45%) and 317 (44.71%) drugs as off-label as per the NFI and BNF, respectively. Prescriptions with minimum 1 off-label drug use were 78.05% - BNF and 46.83% - NFI. The indication was one of the most common causes of drugs being off-label. Out of the total 317 off-label drug uses reported, 84 were unlicensed drug use as per the BNF. There is strong and positive correlation established between the age of the patients, number of drugs prescribed, and total off-label drugs prescribed per patient in the given study. The most common off-label drug use noted was with clonazepam and amitriptyline. CONCLUSION: Off-label prescriptions practice is common in the field of neurology.

Prevalence of potentially inappropriate medications and prescription cost analysis among older cardiac patients in an outpatient department of a tertiary care hospital in India.

AIMS: The aim of this study is to evaluate potentially inappropriate medications (PIMs) in the elderly at cardiology outpatient department (OPD) of a tertiary care teaching hospital using Beers criteria and to find the direct cost burden of PIMs. MATERIALS AND METHODS: The present study was an observational cross-sectional study. Prescriptions of the patients' aged ≥65 years were collected from the cardiology OPD and were analyzed. PIMs were identified with the help of Beers 2012 criteria. Direct costs of prescribed drugs were calculated. Predictors (comorbid conditions, number of drugs prescribed) associated with PIM use were identified using bivariate analysis. Multivariate logistic regression was then applied to study the influence of these variables on PIM use. A P < 0.05 was considered statistically significant. RESULTS: A total of 236 patients received 1443 drugs. According to Beers 2012 criteria, 29.3% patients received at least one PIM followed by two and three PIMs in 10 and 23 patients, respectively. The most commonly prescribed PIM was spironolactone in 15.7% patients followed by benzodiazepines in 15 patients. The total cost of therapy for 1 day was Indian Rupee (INR) 10,029.2 while total cost of all prescribed medications in per day was INR 42.5. CONCLUSIONS: This study showed higher use of PIMs among the elderly in cardiac OPD. It is important to improve the situation of older cardiac patients who have higher use of PIMs. In older patients, high prevalence of PIMs was associated with increased cost. The use of regular continuing medical education program by the hospital and educating and training doctors on rational prescribing will help alleviate this issue.

Challenges in the successful management of a case of acute intermittent porphyria in India.

Acute intermittent porphyria (AIP) is a rare metabolic disease involving a defect in haem biosynthesis resulting in the accumulation and excessive secretion of porphyrins and its precursors. Acute attacks present with episodes of severe abdominal pain, nausea, confusion and severe life-threatening seizures. A high index of suspicion is required for the initial diagnosis of AIP.

Preparation and Characterization of Self-Microemulsifying Drug Delivery System of Olmesartan Medoxomil for Bioavailability Improvement.

Olmesartan medoxomil (OLM) is an angiotensin II receptor blocker (ARB) antihypertensive agent administered orally that has absolute bioavailability of only 26% due to the poor aqueous solubility (7.75 µg/ml). The aim of the present investigation was to develop a self-microemulsifying drug delivery system (SMEDDS) to enhance the oral absorption of OLM. The solubility of OLM in various oils, surfactants, and cosurfactants was determined. Pseudoternary phase diagrams were constructed using Acrysol EL 135, Tween 80, Transcutol P, and distilled water to identify the efficient self-microemulsification region. Prepared SMEDDS was further evaluated for its emulsification time, drug content, optical clarity, droplet size, zeta potential, in vitro dissolution, and in vitro and ex vivo drug diffusion study. The optimized formulation S2 contained OLM (20 mg), Tween 80 (33%v/v), Transcutol P (33%v/v), and Acrysol EL 135 (34%v/v) had shown the smallest particle size, maximum solubility, less emulsification time, good optical clarity, and in vitro release. The in vitro and ex vivo diffusion rate of the drug from the SMEDDS was significantly higher than that of the plain drug suspension. It was concluded that SMEDDS would be a promising drug delivery system for poorly water-soluble drugs by the oral route.