Phase 2 randomised placebo-controlled trial of spironolactone and dexamethasone versus dexamethasone in COVID-19 hospitalised patients in Delhi.

BACKGROUND: In this phase 2 randomised placebo-controlled clinical trial in patients with COVID-19, we hypothesised that blocking mineralocorticoid receptors using a combination of dexamethasone to suppress cortisol secretion and spironolactone is safe and may reduce illness severity. METHODS: Hospitalised patients with confirmed COVID-19 were randomly allocated to low dose oral spironolactone (50 mg day 1, then 25 mg once daily for 21 days) or standard of care in a 2:1 ratio. Both groups received dexamethasone 6 mg daily for 10 days. Group allocation was blinded to the patient and research team. Primary outcomes were time to recovery, defined as the number of days until patients achieved WHO Ordinal Scale (OS) category ≤ 3, and the effect of spironolactone on aldosterone, D-dimer, angiotensin II and Von Willebrand Factor (VWF). RESULTS: One hundred twenty patients with PCR confirmed COVID were recruited in Delhi from 01 February to 30 April 2021. 74 were randomly assigned to spironolactone and dexamethasone (SpiroDex), and 46 to dexamethasone alone (Dex). There was no significant difference in the time to recovery between SpiroDex and Dex groups (SpiroDex median 4.5 days, Dex median 5.5 days, p = 0.055). SpiroDex patients had significantly lower D-dimer levels on days 4 and 7 (day 7 mean D-dimer: SpiroDex 1.15 µg/mL, Dex 3.15 µg/mL, p = 0.0004) and aldosterone at day 7 (SpiroDex 6.8 ng/dL, Dex 14.52 ng/dL, p = 0.0075). There was no difference in VWF or angiotensin II levels between groups. For secondary outcomes, SpiroDex patients had a significantly greater number of oxygen free days and reached oxygen freedom sooner than the Dex group. Cough scores were no different during the acute illness, however the SpiroDex group had lower scores at day 28. There was no difference in corticosteroid levels between groups. There was no increase in adverse events in patients receiving SpiroDex. CONCLUSION: Low dose oral spironolactone in addition to dexamethasone was safe and reduced D-dimer and aldosterone. Time to recovery was not significantly reduced. Phase 3 randomised controlled trials with spironolactone and dexamethasone should be considered. TRIAL REGISTRATION: The trial was registered on the Clinical Trials Registry of India TRI: CTRI/2021/03/031721, reference: REF/2021/03/041472. Registered on 04/03/2021.

Professional Quality of Life in Intensive Care Unit Professionals during COVID-19 Pandemic: A Prospective Observational Cross-sectional Study.

Background and aims: The coronavirus disease-2019 (COVID-19) has significant positive and negative impacts on the professional life of intensive care unit (ICU) professionals. This study was conducted to evaluate compassion satisfaction (CS), burnout (BO), and secondary traumatic stress (STS) in ICU professionals and to study demographic and occupational variables related to them. Methods: This prospective observational study was undertaken on ICU professionals involved in direct care of critically ill COVID-19 patients. The online questionnaire consisting of demographic, work-related parameters, and professional quality of life scale version 5 (ProQOL 5) was sent to 1,080 ICU healthcare workers. The subgroups of ProQOL 5, CS, BO, and STS were calculated and compared across study parameters. Linear regression was performed to evaluate variables which were independently associated with ProQOL. Results: The response rate in the present study was 39.8%, and after evaluation, 320 responses were found eligible for final analysis. There was predominance of average levels of CS, BO, and STS. Female gender, contractual job, lesser work experience, greater workload, and COVID-19 infection in close acquittance of participants were factors observed to independently associated with increase in negative aspects of ProQOL (BO and STS). Further, increase in duty hours and COVID-19 infection in close social circle were observed to independently decrease positive aspects (CS). Conclusion: This study shows that despite majority of respondents reporting moderate levels BO and STS, CS is maintained during the COVID-19 crisis. The identification of risk factors is vital to support ICU professionals by targeted interventions. How to cite this article: Kerai S, Doda P, Saxena KN. Professional Quality of Life in Intensive Care Unit Professionals during COVID-19 Pandemic: A Prospective Observational Cross-sectional Study. Indian J Crit Care Med 2022;26(5):604-612.

A Retrospective Study on Experience of High-flow Nasal Cannula Oxygen in Critically Ill COVID-19 Adult Patients Admitted to Intensive Care Unit.

BACKGROUND: The use of high-flow nasal cannula (HFNC) in coronavirus disease-2019 (COVID-19) patients is debated due to its uncertain benefits and risks of aerosol dispersion. This retrospective study was aimed to assess the outcome of treatment with HFNC therapy in adult COVID-19 patients with acute hypoxemic respiratory failure (AHRF) admitted in intensive care units (ICU) and to assess the factors affecting outcome. MATERIAL AND METHODS: We retrieved electronic medical records of all COVID-19 patients who received HFNC for respiratory support after failure to maintain adequate oxygenation with conventional oxygen devices, between June 1 and August 31, 2020. The data retrieved were statistically analyzed. RESULTS: A total number of 558 COVID-19 patients were admitted to ICUs, out of which 139 patients were identified to be on HFNC and 85 met the inclusion criteria for the study. The success rate of 48.2% with HFNC was observed in these patients. The patients recorded to experience HFNC success were of young age and having higher baseline oxygen saturation compared to those who had its failure. The ROX indices post-initiation were observed to be significantly higher in the success group (p ≤0.001). Awake-prone positioning while receiving HFNC was followed by around more patients in the success group (p <0.001). On multivariate logistic regression analysis, baseline oxygen saturation, awake-prone positioning, and number of days on HFNC were found to be independently affected outcome with HFNC. CONCLUSION: Almost half of the cases of moderate-to-severe COVID-19 pneumonia can be managed successfully with HFNC, without the need of mechanical ventilation. HOW TO CITE THIS ARTICLE: Kerai S, Singh R, Saxena KN, Desai SD, Bhalotra AR. A Retrospective Study on Experience of High-flow Nasal Cannula Oxygen in Critically Ill COVID-19 Adult Patients Admitted to Intensive Care Unit. Indian J Crit Care Med 2022;26(1):62-66.

Assessment of Risk Factors for Coronavirus Disease-2019 in Healthcare Workers: A Case-Control Study.

BACKGROUND AND AIMS: With the rise of coronavirus disease-2019 (COVID-19) cases globally, the infection among frontline healthcare workers (HCWs) escalates many folds. There is, however, limited literature from low middle-income countries regarding risk factors for COVID-19 infection in HCWs. We conducted a case-control study to evaluate the risk factors of COVID-19 infection to HCWs. MATERIALS AND METHODS: This case-control study was conducted in a designated COVID-19 hospital. Eighty-one HCWs involved in direct care of COVID-19 patients, identified as cases, and 266 were recruited as controls. Telephonic interviews with participants were conducted, and information regarding demographic variables, chemoprophylaxis, exposure to infected patients, and adherence to infection prevention and control (IPC) measures was collected. RESULTS: We observed a statistically significant difference in the number of times training session for IPC measures attended by HCWs (p = 0.02), performance of aerosol-generating medical procedures (AGMPs) (p <0.001), practices of donning and doffing of personal protective equipment (PPE) (p <0.001), hand hygiene (p <0.001), and decontamination of highly touched surfaces (p <0.001). Logistic regression analysis revealed if the decontamination of highly touched surfaces is decreased by one unit, the odds of getting COVID-19 infection is multiplied by a factor of 0.41 and AGMPs decrease the risk of being a case by 0.76. CONCLUSION: This study highlighted that inadequate observation of IPC methods increases the risk of COVID-19 infection to frontline HCWs, whereas performance of AGMPs does not enhance the risk. In this study, HCWs undertaking an AGMP, because of concern of acquiring infection, were more diligent during procedures and hence had lesser infection. HOW TO CITE THIS ARTICLE: Kerai S, Singh R, Saxena KN, Desai SD. Assessment of Risk Factors for Coronavirus Disease-2019 in Healthcare Workers: A Case-Control Study. Indian J Crit Care Med 2022;26(1):76-84.

Evidence of the presence of SARS-CoV-2 virus in atmospheric air and surfaces of a dedicated COVID hospital.

The present study was conducted from July 1, 2020 to September 25, 2020 in a dedicated coronavirus disease 2019 (COVID-19) hospital in Delhi, India to provide evidence for the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus in atmospheric air and surfaces of the hospital wards. Swabs from hospital surfaces (patient's bed, ward floor, and nursing stations area) and suspended particulate matter in ambient air were collected by a portable air sampler from the medicine ward, intensive care unit, and emergency ward admitting COVID-19 patients. By performing reverse-transcriptase polymerase chain reaction (RT-PCR) for E-gene and RdRp gene, SARS-CoV-2 virus was detected from hospital surfaces and particulate matters from the ambient air of various wards collected at 1 and 3-m distance from active COVID-19 patients. The presence of the virus in the air beyond a 1-m distance from the patients and surfaces of the hospital indicates that the SARS-CoV-2 virus has the potential to be transmitted by airborne and surface routes from COVID-19 patients to health-care workers working in COVID-19 dedicated hospital. This warrants that precautions against airborne and surface transmission of COVID-19 in the community should be taken when markets, industries, educational institutions, and so on, reopen for normal activities.