Indian Society of Critical Care Medicine Consensus Statement for Prevention of Venous Thromboembolism in the Critical Care Unit.

Deep vein thrombosis (DVT) is a preventable complication of critical illness, and this guideline aims to convey a pragmatic approach to the problem. Guidelines have multiplied over the last decade, and their utility has become increasingly conflicted as the reader interprets all suggestions or recommendations as something that must be followed. The nuances of grade of recommendation vs level of evidence are often ignored, and the difference between a "we suggest" vs a "we recommend" is overlooked. There is a general unease among clinicians that failure to follow the guidelines translates to poor medical practice and legal culpability. We attempt to overcome these limitations by highlighting ambiguity when it occurs and refraining from dogmatic recommendations in the absence of robust evidence. Readers and practitioners may find the lack of specific recommendations unsatisfactory, but we believe that true ambiguity is better than inaccurate certainty. We have attempted to comply with the guidelines on how to create guidelines.1 And to overcome the poor compliance with these guidelines.2 Some observers have expressed concern that DVT prophylaxis guidelines may cause more harm than good.3 We have placed greater emphasis on large randomized controlled trials (RCTs) with clinical end point and de-emphasized RCTs with surrogate end points and also de-emphasized hypothesis generating studies (observational studies, small RCTs, and meta-analysis of these studies). We have de-emphasized RCTs in non-intensive care unit populations like postoperative patients or those with cancer and stroke. We have also considered resource limitation settings and have avoided recommending costly and poorly proven therapeutic options. How to cite this article: Jagiasi BG, Chhallani AA, Dixit SB, Kumar R, Pandit RA, Govil D, et al. Indian Society of Critical Care Medicine Consensus Statement for Prevention of Venous Thromboembolism in the Critical Care Unit. Indian J Crit Care Med 2022;26(S2):S51-S65.

Approach to Thromboprophylaxis for Prevention of Venous Thromboembolism in COVID-19: Global Updates and Clinical Insights from India.

Venous thromboembolism (VTE) frequently occurs in patients with coronavirus disease-19 (COVID-19) and is associated with increased mortality. Several global guidelines recommended prophylactic-intensity anticoagulation rather than intermediate-intensity or therapeutic-intensity anticoagulation for patients with COVID-19-related acute or critical illness without suspected or confirmed VTE. Even though standard doses of thromboprophylaxis are received, many cases of thrombotic complications are reported; hence, appropriate and adequate thromboprophylaxis is critical for the prevention of VTE in COVID-19. In spite of an increased prevalence of VTE in Indian patients, sufficient data on patient characteristics, diagnosis, and therapeutic approach for VTE in COVID is lacking. In this article, we review the available global literature (search conducted up to 31 May 2021) and provide clinical insights into our approach towards managing VTE in patients with COVID-19. Furthermore, in this review, we summarize the incidence and risk factors for VTE with emphasis on the thromboprophylaxis approach in hospitalized patients and special populations with COVID-19 and assess clinical implications in the Indian context.

Tocilizumab plus standard care versus standard care in patients in India with moderate to severe COVID-19-associated cytokine release syndrome (COVINTOC): an open-label, multicentre, randomised, controlled, phase 3 trial.

BACKGROUND: Global randomised controlled trials of the anti-IL-6 receptor antibody tocilizumab in patients admitted to hospital with COVID-19 have shown conflicting results but potential decreases in time to discharge and burden on intensive care. Tocilizumab reduced progression to mechanical ventilation and death in a trial population enriched for racial and ethnic minorities. We aimed to investigate whether tocilizumab treatment could prevent COVID-19 progression in the first multicentre randomised controlled trial of tocilizumab done entirely in a lower-middle-income country. METHODS: COVINTOC is an open-label, multicentre, randomised, controlled, phase 3 trial done at 12 public and private hospitals across India. Adults (aged ≥18 years) admitted to hospital with moderate to severe COVID-19 (Indian Ministry of Health grading) confirmed by positive SARS-CoV-2 PCR result were randomly assigned (1:1 block randomisation) to receive tocilizumab 6 mg/kg plus standard care (the tocilizumab group) or standard care alone (the standard care group). The primary endpoint was progression of COVID-19 (from moderate to severe or from severe to death) up to day 14 in the modified intention-to-treat population of all participants who had at least one post-baseline assessment for the primary endpoint. Safety was assessed in all randomly assigned patients. The trial is completed and registered with the Clinical Trials Registry India (CTRI/2020/05/025369). FINDINGS: 180 patients were recruited between May 30, 2020, and Aug 31, 2020, and randomly assigned to the tocilizumab group (n=90) or the standard care group (n=90). One patient randomly assigned to the standard care group inadvertently received tocilizumab at baseline and was included in the tocilizumab group for all analyses. One patient randomly assigned to the standard care group withdrew consent after the baseline visit and did not receive any study medication and was not included in the modified intention-to-treat population but was still included in safety analyses. 75 (82%) of 91 in the tocilizumab group and 68 (76%) of 89 in the standard care group completed 28 days of follow-up. Progression of COVID-19 up to day 14 occurred in eight (9%) of 91 patients in the tocilizumab group and 11 (13%) of 88 in the standard care group (difference -3·71 [95% CI -18·23 to 11·19]; p=0·42). 33 (36%) of 91 patients in the tocilizumab group and 22 (25%) of 89 patients in the standard care group had adverse events; 18 (20%) and 15 (17%) had serious adverse events. The most common adverse event was acute respiratory distress syndrome, reported in seven (8%) patients in each group. Grade 3 adverse events were reported in two (2%) patients in the tocilizumab group and five (6%) patients in the standard care group. There were no grade 4 adverse events. Serious adverse events were reported in 18 (20%) patients in the tocilizumab group and 15 (17%) in the standard care group; 13 (14%) and 15 (17%) patients died during the study. INTERPRETATION: Routine use of tocilizumab in patients admitted to hospital with moderate to severe COVID-19 is not supported. However, post-hoc evidence from this study suggests tocilizumab might still be effective in patients with severe COVID-19 and so should be investigated further in future studies. FUNDING: Medanta Institute of Education and Research, Roche India, Cipla India, and Action COVID-19 India.

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.

Early CT in COVID-19: Should I or Should I Not?

How to cite this article: Govil D, Kumar GP. Early CT in COVID-19: Should I or Should I Not? Indian J Crit Care Med 2021;25(3):251-252.

Airway Management and Related Procedures in Critically Ill COVID-19 Patients: Position Statement of the Indian Society of Critical Care Medicine.

The coronavirus disease (COVID-19) pandemic has affected nearly all nations globally. The highly contagious nature of the disease puts the healthcare workers at high risk of acquiring infection, especially while handling airway and performing aerosol-generating procedures. The Indian Society of Critical Care Medicine, through this position paper, aims to provide guidance for safe airway management to all healthcare workers dealing with airway in COVID-19 patients. HOW TO CITE THIS ARTICLE: Praveen Kumar G, Kulkarni AP, Govil D, Dixit SB, Chaudhry D, Samavedam S, et al. Airway Management and Related Procedures in Critically Ill COVID-19 Patients: Position Statement of the Indian Society of Critical Care Medicine. Indian J Crit Care Med 2020;24(8):630-642.

Basic Critical Care for Management of COVID-19 Patients: Position Paper of Indian Society of Critical Care Medicine, Part-I.

With more than 23 million infections and more than 814,000 deaths worldwide, the coronavirus disease-2019 (COVID-19) pandemic is still far from over. Several classes of drugs including antivirals, antiretrovirals, anti-inflammatory, immunomodulatory, and antibiotics have been tried with varying levels of success. Still, there is lack of any specific therapy to deal with this infection. Although less than 30% of these patients require intensive care unit admission, morbidity and mortality in this subgroup of patients remain high. Hence, it becomes imperative to have general principles to guide intensivists managing these patients. However, as the literature emerges, these recommendations may change and hence, frequent updates may be required. How to cite this article: Juneja D, Savio RD, Srinivasan S, Pandit RA, Ramasubban S, Reddy PK, et al. Basic Critical Care for Management of COVID-19 Patients: Position Paper of Indian Society of Critical Care Medicine, Part-I. Indian J Crit Care Med 2020;24(Suppl 5):S244-S253.

Multi-organ point-of-care ultrasound for COVID-19 (PoCUS4COVID): international expert consensus.

COVID-19 has caused great devastation in the past year. Multi-organ point-of-care ultrasound (PoCUS) including lung ultrasound (LUS) and focused cardiac ultrasound (FoCUS) as a clinical adjunct has played a significant role in triaging, diagnosis and medical management of COVID-19 patients. The expert panel from 27 countries and 6 continents with considerable experience of direct application of PoCUS on COVID-19 patients presents evidence-based consensus using GRADE methodology for the quality of evidence and an expedited, modified-Delphi process for the strength of expert consensus. The use of ultrasound is suggested in many clinical situations related to respiratory, cardiovascular and thromboembolic aspects of COVID-19, comparing well with other imaging modalities. The limitations due to insufficient data are highlighted as opportunities for future research.

Critical Care for COVID-19 Affected Patients: Updated Position Statement of the Indian Society of Critical Care Medicine.

The management of coronavirus disease-2019 (COVID-19) is witnessing a change as we learn more about the pathophysiology and the severity of the disease. Several randomized controlled trials (RCTs) and meta-analysis have been published over the last few months. Several interventions and therapies which showed promise in the initial days of the pandemic have subsequently failed to show benefit in well-designed trials. Understanding of the methods of oxygen delivery and ventilation have also evolved over the past few months. The Indian Society of Critical Care Medicine (ISCCM) has reviewed the evidence that has emerged since the publication of its position statement in May and has put together an addendum of updated evidence. How to cite this article: Mehta Y, Chaudhry D, Abraham OC, Chacko J, Divatia J, Jagiasi B, et al. Critical Care for COVID-19 Affected Patients: Position Statement of the Indian Society of Critical Care Medicine. Indian J Crit Care Med 2020;24(Suppl 5):S225-S230.

Procedures in COVID-19 Patients: Part-II.

Critical care in the era of novel coronavirus disease-2019 (COVID-19) infection has multiple challenges including management of the patient, underlying comorbidities, and the complications. With no end in sight to the pandemic, intensive care unit (ICU) practitioners and hospital administrators have to join hands to prepare for the long battle ahead. Critically ill COVID-19 patients need imaging or image-guided interventions in one form or the other including X-rays, ultrasonography (USG), echocardiography (ECHO), and CT scan. These patients often require renal replacement therapy (RRT) for either the preexisting chronic renal insufficiency or acutely developing kidney injury. Another important component of care is transfer of the patient to and fro from the ICU or to higher care centers. Most of the ICUs are equipped with modern facilities but with increasing number of patients a large number of makeshift arrangements are being made for managing these patients. This position paper outlines important tips to formulate protocols and procedures for critically ill patients, who are managed in the ICU. How to cite this article: Pande RK, Bhalla A, Myatra SN, Yaddanpuddi LN, Gupta S, Sahoo TK, et al. Procedures in COVID-19 Patients: Part-II. Indian J Crit Care Med 2020;24(Suppl 5):S272-S279.

Procedures in COVID-19 Patients: Part-I.

The number of cases with novel coronavirus disease-2019 (COVID-19) infection is increasing every day in the world, and India contributes a substantial proportion of this burden. Critical care specialists have accepted the challenges associated with the COVID-19 pandemic and are frontline warriors in this war. They have worked hard in streamlining workflow isolation of positive patients, clinical management of critically ill patients, and infection prevention practices. With no end in sight for this pandemic, intensive care unit (ICU) practitioners, hospital administrators, and policy makers have to join hands to prepare for the surge in critical care bed capacity. In this position article, we offer several suggestions on important interventions to the ICU practitioners for better management of critically ill patients. This position article highlights key interventions for COVID-19 treatment and covers several important issues such as endotracheal intubation and tracheostomy (surgical vs PCT), nebulization, bronchoscopy, and invasive procedures such as central venous catheters, arterial lines, and HD catheters. How to cite this article: Pande RK, Bhalla A, SN Myatra, Yaddanpuddi LN, Gupta S, Sahoo TK, et al. Procedures in COVID-19 Patients: Part-I. Indian J Crit Care Med 2020;24(Suppl 5):S263-S271.

Basic Critical Care for Management of COVID-19 Patients: Position Paper of the Indian Society of Critical Care Medicine, Part II.

In a resource-limited country like India, rationing of scarce critical care resources might be required to ensure appropriate delivery of care to the critically ill patients suffering from COVID-19 infection. Most of these patients require critical care support because of respiratory failure or presence of multiorgan dysfunction syndrome. As there is no pharmacological therapy available, respiratory support in the form of supplemental oxygen, noninvasive ventilation, and invasive mechanical ventilation remains mainstay of care in intensive care units. As there is still dearth of direct evidence, most of the data are extrapolated from the experience gained from the management of general critical care patients. How to cite this article: Juneja D, Savio RD, Srinivasan S, Pandit RA, Ramasubban S, Reddy PK, et al. Basic Critical Care for Management of COVID-19 Patients: Position Paper of the Indian Society of Critical Care Medicine, Part II. Indian J Crit Care Med 2020;24(Suppl 5):S254-S262.

Current Approaches to COVID-19: Therapy and Prevention.

The coronavirus disease-2019 (COVID-19) pandemic has affected millions of people worldwide. As our understanding of the disease is evolving, our approach to the patient management is also changing swiftly. Available new evidence is helping us take radical decisions in COVID-19 management. We searched for inclusion of the published literature on treatment of COVID-19 from around the globe. All relevant evidences available till the time of submission of this article were briefly discussed. Once advised as blanket therapy for all patients, recent reports of hydroxychloroquine with or without azithromycin indicated no potential benefit and use of such combination may increase the risk of arrhythmias. Clinical evidence with newer antivirals such as remdesivir and favipiravir is promising that can hasten the patient recovery and reduce the mortality. With steroids, evidence is much clear in that it should be used in low dose and for short period not extending beyond 7 days in moderate to severe hospitalized patients. Low-molecular-weight heparin should be initiated in all hospitalized COVID-19 patients and dose should be based on the coagulation profile and risk of thromboembolism. Immunomodulatory drugs such tocilizumab may be considered for severe and critically ill patients to improve the outcomes. Though ulinastatin can be a potential alternative immunomodulator, there is lack of clinical evidence on its usage in COVID-19. Convalescent plasma therapy can be potentially lifesaving in critically ill patients. However, there is need to generate further evidence with various such therapies. Though availability of a potent vaccine is awaited, current treatment of COVID-19 is based on available therapies, which is guided by the evidence. In this review, we discuss the potential treatments available around the globe with current evidence on each of such treatments. How to cite this article: Dixit SB, Zirpe KG, Kulkarni AP, Chaudhry D, Govil D, Mehta Y, et al. Current Approaches to COVID-19: Therapy and Prevention. Indian J Crit Care Med 2020;24(9):838-846.

Restructuring Living-Donor Liver Transplantation at a High-Volume Center During the COVID-19 Pandemic.

BACKGROUND: Coronavirus disease 2019 (COVID-19) pandemic has led to deferral of elective transplants and proactive pretransplant testing of the donor/recipient. The impact of these on living-donor liver transplantation (LDLT) activity and outcome is not known. We performed LDLT only for sick patients or patients with advanced hepatocellular carcinoma in this period, with special COVID protocols. METHODS: Patients undergoing LDLT counseling, evaluation, and transplant in the period March to June 2020 (group A) under COVID-19 restrictions and special protocols were included. LDLT activity and outcomes among these patients were compared with those in the same period in 2019 (group B). RESULTS: In the period March 15-June 10, we performed 39 and 23 (59%) LDLTs in 2019 and 2020, respectively. The adult patients with cirrhosis in group A (n = 20) had a significantly higher MELD score, 19.8 ± 7.0 versus 16.1 ± 5.6 in group B (n = 36), p = 0.034. Early recipient mortality was similar in 2019 (2/39) and 2020 (2/23). One of 23 post-transplant recipients, 3/71 recipients and donors during evaluation, and 8/125 healthcare workers (HCWs) developed COVID-19, all of whom recovered uneventfully. CONCLUSION: LDLT activity substantially reduced during the COVID era. The incidence and outcome of COVID-19 among the waiting or transplanted patients and HCWs were similar to those of the general population. The outcome after LDLT in the COVID era was similar to that in non-COVID times. These data suggest that LDLT may be extended to more stable patients with strict protocols.

Systemic Involvement of Novel Coronavirus (COVID-19): A Review of Literature.

COVID-19 outbreak has caused a pandemonium in modern world. As the virus has spread its tentacles across nations, territories, and continents, the civilized society has been compelled to face an unprecedented situation, never experienced before during peacetime. We are being introduced to an ever-growing new terminologies: "social distancing," "lockdown," "stay safe," "key workers," "self-quarantine," "work-from-home," and so on. Many countries across the globe have closed their borders, airlines have been grounded, movement of public transports has come to a grinding halt, and personal vehicular movements have been restricted or barred. In the past couple of months, we have witnessed mayhem in an unprecedented scale: social, economic, food security, education, business, travel, and freedom of movements are all casualties of this pandemic. Our experience about this virus and its epidemiology is limited, and mostly the treatment for symptomatic patients is supportive. However, it has been observed that COVID-19 not only attacks the respiratory system; rather it may involve other systems also from the beginning of infection or subsequent to respiratory infection. In this article, we attempt to describe the systemic involvement of COVID-19 based on the currently available experiences. This description is up to date as of now, but as more experiences are pouring from different corners of the world, almost every day, newer knowledge and information will crop up by the time this article is published. HOW TO CITE THIS ARTICLE: Munjal M, Das S, Chatterjee N, Setra AE, Govil D. Systemic Involvement of Novel Coronavirus (COVID-19): A Review of Literature. Indian J Crit Care Med 2020;24(7):565-569.

Prone for COVID: Are You Awake?

How to cite this article: Gupta S, Govil D. Prone for COVID: Are You Awake? Indian J Crit Care Med 2020;24(7):504-505.

Critical Care for COVID-19 Affected Patients: Position Statement of the Indian Society of Critical Care Medicine.

The global pandemic involving severe acute respiratory syndrome-coronavirus-2 (SARS-COV-2) has stretched the limits of science. Ever since it emerged from the Wuhan province in China, it has spread across the world and has been fatal to about 4% of the victims. This position statement of the Indian Society of Critical Care Medicine represents the collective opinion of the experts chosen by the society. HOW TO CITE THIS ARTICLE: Mehta Y, Chaudhry D, Abraham OC, Chacko J, Divatia J, Jagiasi B, et al. Critical Care for COVID-19 Affected Patients: Position Statement of the Indian Society of Critical Care Medicine. Indian J Crit Care Med 2020;24(4):222-241.