A Pilot Feasibility Randomized Controlled Trial of Intravenous Vitamin C in Adults with Sepsis in the Intensive Care Unit: The Lessening Organ Dysfunction with Vitamin C-India (LOVIT-India) Trial.

Background: The burden of sepsis is high in India and is associated with substantial morbidity and mortality. Vitamin C, an endogenous antioxidant, may improve patient outcomes. Methods: This was a parallel-group pilot feasibility randomized controlled trial conducted at 2 intensive care units in India. Adult patients (≥18 years) with proven or suspected infection as the main diagnosis and needing a continuous intravenous vasopressor infusion were randomized to intravenous vitamin C (50 mg/kg every 6 hours for a maximum of 16 doses) or matching placebo. Primary outcomes were related to protocol adherence and feasibility (enrollment per month). The key secondary outcome was the composite of mortality or persistent organ dysfunction (POD) at day 28 after randomization. Results: 60 patients were screened, 51 were eligible, 32 were randomized, and 30 were included in the analysis (randomized/eligible ratio: 0.63). The overall rate of enrollment was 1.5 patients per month. The median (IQR) age was 63.5 (51.0, 70.0) and 70.0% of the patients were male. In both arms, all patients received ≥90% of scheduled doses of the study drug. No patient received open-label vitamin C and there were no deviations from the glucose monitoring protocol. The composite outcome of mortality or POD at day 28 occurred in 56.3% (9/16) in the vitamin C arm as compared to 42.9% (6/14) in the placebo arm [RR: 1.31 (95% CI: 0.62, 2.76), p = 0.47]. Conclusion: In this pilot feasibility randomized controlled trial of vitamin C for adult patients with sepsis, protocol adherence was excellent and feasibility endpoints were met. Trial registration: CTRI/2020/03/024371. How to cite this article: Vijayaraghavan BKT, Venkataraman R, Ramanathan Y, Margabandhu S, Jayakumar D, Ramachandran P, et al. A Pilot Feasibility Randomized Controlled Trial of Intravenous Vitamin C in Adults with Sepsis in the Intensive Care Unit: The Lessening Organ Dysfunction with Vitamin C-India (LOVIT-India) Trial. Indian J Crit Care Med 2023;27(12):910-916.

Scope, Safety, and Feasibility of Therapeutic Plasma Exchange in Pediatric Intensive Care Unit: A Single-center Experience.

Background: Indications for therapeutic plasma exchange (TPE) in the pediatric intensive care unit (PICU) are expanding. We aimed to study the demographics, clinical indications, and outcomes of patients who have undergone TPE in our PICU. Materials and methods: This is a retrospective study performed among children aged from 1 month to 16 years of age. Demographics, indications, therapeutic response, serious adverse events (SAE), PICU length of stay (LOS), and death during hospitalization were studied as outcome variables. Results: Therapeutic plasma exchange was performed in 115 sessions on 24 patients for 12 different indications falling under various American Society for Apheresis (ASFA) categories. Therapeutic plasma exchange was performed on ten, four, and ten children for ASFA category I, II, and III indications, respectively. The most common indications were thrombotic microangiopathy (TMA) (8/24) and acute liver failure (ALF) (6/24). During those 115 sessions, a total of five serious adverse events (SAEs) occurred, accounting for 4.3% of the cases. Minor adverse events occurred in 12 sessions (10.4%). Therapeutic response was good in 17 patients (71%) including 5 patients who underwent standard volume TPE (SV-TPE) for ALF. Median PICU LOS was 9 (range 2-120) days. The mortality rate was 12.5% (3/24). Conclusion: Therapeutic plasma exchange is effective in various clinical conditions involving various organ systems. It is an excellent therapeutic modality in children with ALF, irrespective of the exchange volume and TMA. However, SAEs do occur in the minority. How to cite this article: Balasubramanian KK, Venkatachalapathy P, Margabandhu S, Natraj R, Sridaran VK, Lakshmanan C, et al. Scope, Safety, and Feasibility of Therapeutic Plasma Exchange in Pediatric Intensive Care Unit: A Single-center Experience. Indian J Crit Care Med 2023;27(10):766-770.

ISCCM Guidelines on Acute Kidney Injury and Renal Replacement Therapy.

Acute kidney injury (AKI) is a complex syndrome with a high incidence and considerable morbidity in critically ill patients. Renal replacement therapy (RRT) remains the mainstay of treatment for AKI. There are at present multiple disparities in uniform definition, diagnosis, and prevention of AKI and timing of initiation, mode, optimal dose, and discontinuation of RRT that need to be addressed. The Indian Society of Critical Care Medicine (ISCCM) AKI and RRT guidelines aim to address the clinical issues pertaining to AKI and practices to be followed for RRT, which will aid the clinicians in their day-to-day management of ICU patients with AKI. How to cite this article: Mishra RC, Sodhi K, Prakash KC, Tyagi N, Chanchalani G, Annigeri RA, et al. ISCCM Guidelines on Acute Kidney Injury and Renal Replacement Therapy. Indian J Crit Care Med 2022;26(S2):S13-S42.

Thrombotic thrombocytopenic purpura in a 2.5-year-old boy with dengue infection: a rare complication.

Acute kidney injury (AKI) is a neglected and least studied complication of dengue. AKI secondary to thrombotic thrombocytopenic purpura (TTP) in dengue is extremely rare and there are few case reports. A 2.5-year-old boy with dengue who developed TTP in the critical phase of illness is described. He presented with microangiopathic haemolysis, thrombocytopenia and AKI. Haemolytic uraemic syndrome (HUS)/TTP was suspected and he underwent seven cycles of plasma exchange along with renal replacement therapy, following which he made a complete recovery. Prompt recognition of renal complications in dengue fever and early initiation of appropriate renal replacement therapy along with plasma exchange are essential for a good outcome.Abbreviations: AKI, acute kidney injury; GCS, Glasgow coma scale; HUS, haemolytic uraemic syndrome; LDH, lactate dehydrogenase; NS1, non-structural protein 1; pRIFLE, paediatric risk, injury, failure, loss, end-stage renal disease; SLED, sustained low-efficiency dialysis; TMA, thrombotic microangiopathy; TTP, thrombotic thrombocytopenic purpura.

Therapeutic plasma exchange for pediatric nonrenal disease indications and outcomes: A single-center experience.

INTRODUCTION: Outcome data in pediatric plasma exchange, especially in nonrenal indications are scarce. We aimed to evaluate its role and outcome in our patients. SUBJECTS AND METHODS: A retrospective study of children admitted in the year 2016 to the Pediatric Intensive Care Unit requiring plasma exchange for nonrenal indications was undertaken. Plasma exchange was given as adjunctive therapy along with primary treatment for the disease concerned. Demographic and clinical data were studied, and descriptive statistical analysis was carried out. RESULTS: Ten children underwent plasma exchange during this 1-year period with a male: female ratio of 3:2 and a mean age of 10 years (range 3-16 years). The indications were acute disseminated encephalomyelitis (n = 2), acute neuromyelitis optica (n = 1), catastrophic antiphospholipid antibody syndrome secondary to systemic lupus erythematosus (SLE) (n = 1), severe SLE with cerebritis/hemophagocytic lymphohistiocytosis (HLH) (n = 2), severe dengue sepsis with HLH/multi-organ dysfunction syndrome (n = 2), and thrombotic microangiopathy secondary to snake bite envenomation (n = 2). All received either 1.5 or 2 times plasma volume exchange (mean sessions - 4, range = 1-6). The mean duration of stay in hospital was 17.2 days (range = 3-40 days), and follow-up was 78 days (range = 3-180 days), with the majority of children (8/10, 80%) survived from the catastrophic illness at the time of discharge. Two children (2/10, 20%) succumbed due to the disease per se in severe dengue sepsis in one and enterobacteriaceae sepsis (hospital-acquired pneumonia) in another. CONCLUSION: Plasma exchange was found to be beneficial as complementary therapy in a critical care setting, especially for nonrenal indications.