A bstract Background Sepsis remains a leading cause of death worldwide despite advances in management strategies. Preclinical and observational studies have found mortality benefit with high-dose vitamin C in sepsis. Our study aims to prospectively evaluate the effect of intravenous hydrocortisone, vitamin C [ascorbic acid (AA)], and thiamine (HAT) administration in reducing inpatient all-cause mortality among patients with septic shock. Materials and methods Our single-center, prospective, open-label, randomized controlled trial recruited patients with admitting diagnosis of septic shock and assigned eligible patients (1:1) into either intervention (HAT) or control group (routine). The HAT group received intravenous combination of vitamin C (1.5 g every 6 hours), thiamine (200 mg every 12 hours), and hydrocortisone (50 mg every 6 hours) within 6 hours of onset of septic shock admission. The treatment was continued for at least 4 days, in addition to the routine standard of care provided to the control group. Thiamine and hydrocortisone use in control arm was not restricted. Vitamin C levels were estimated at baseline and at the end of the 4 days of treatment for both groups. The primary outcome evaluated was mortality during inpatient stay. Results Among 90 patients enrolled, 88 patients completed the study protocol. The baseline characteristics between the HAT ( n = 45) and the routine ( n = 43) groups were comparable. The all-cause mortality in the HAT cohort was 57% (26/45) compared to 53% (23/43) in the routine care group ( p = 0.4, OR 1.19, 95% CI 0.51–2.76). The time to reversal of septic shock was significantly lower in the HAT (34.58 ± 22.63 hours) in comparison to the routine care (45.42 ± 24.4 hours) ( p = 0.03, mean difference −10.84, 95% CI −20.8 to −0.87). No significant difference was observed between the HAT and the routine care with respect to changes in sequential organ failure assessment (SOFA) scores at 72 hours (2.23 ± 2.4 vs 1.38 ± 3.1), the use of mechanical ventilation (48% vs 46%), and mean Vasoactive Inotropic Score (7.77 ± 12.12 vs 8.86 ± 12.5). Conclusion Intravenous administration of vitamin C, thiamine, and hydrocortisone did not significantly improve the inpatient all-cause mortality among patients with septic shock. Clinical significance HAT protocol does not reduce hospital mortality but decreases time to shock reversal in septic shock. How to cite this article Mohamed ZU, Prasannan P, Moni M, Edathadathil F, Prasanna P, Menon A, et al. Vitamin C Therapy for Routine Care in Septic Shock (ViCTOR) Trial: Effect of Intravenous Vitamin C, Thiamine, and Hydrocortisone Administration on Inpatient Mortality among Patients with Septic Shock. Indian J Crit Care Med 2020;24(8...
Background Antimicrobial resistance is a major public health threat internationally but, particularly in India. A primary contributing factor to this rise in resistance includes unregulated access to antimicrobials. Implementing antimicrobial stewardship programs (ASPs) in the acute hospital setting will help curb inappropriate antibiotic use in India. Currently, ASPs are rare in India but are gaining momentum. This study describes ASP implementation in a large, academic, private, tertiary care center in India. Methods An ASP was established in February 2016 consisting of an administrative champion, hospitalist, microbiologist, intensivist, and pharmacists. Antimicrobial stewardship program interventions included postprescriptive audit and establishment of institutional guidelines. The ASP tracked appropriate drug selection including loading dose, maintenance dose, frequency, route, duration of therapy, de-escalation, and compliance with ASP recommendations. Defined daily dose (DDD) of drugs and cost of antimicrobials were compared between the pre-implementation phase (February 2015–January 2016) and post-implementation phase (February 2016–January 2017). Results Of 48 555 patients admitted during the post-implementation phase, 1020 received 1326 prescriptions for restricted antibiotics. Antibiotic therapy was appropriate in 56% (742) of the total patient prescriptions. A total of 2776 instances of “inappropriate” antimicrobial prescriptions were intervened upon by the ASP. Duration (806, 29%) was the most common reason for inappropriate therapy. Compliance with ASP recommendations was 54% (318). For all major restricted drugs, the DDD/1000 patient days declined, and there was a significant reduction in mean monthly cost by 14.4% in the post-implementation phase. Conclusions Implementation of a multidisciplinary antibiotic stewardship program in this academic, large, Indian hospital demonstrated feasibility and economic benefits.
P Pu ur rp po os se e: : To compare the efficacy of stimulation of P6 acupoint with capsicum plaster in comparison with iv ondansetron for the prevention of postoperative nausea and vomiting (PONV).M Me et th ho od ds s: : 120 patients of either sex, ASA I-II, undergoing elective middle ear surgeries under general anesthesia were included in this randomized, prospective, double-blinded and placebo-controlled study. The anesthetic technique was standardized. Patients were divided into three groups. Group I was the control group. Capsicum plaster (1 × 1cm) was affixed at the P6 acupoint on both forearms 30 min before induction of anesthesia in patients of Group II. Patients of Groups I and III received an inactive adhesive plaster at the same site. Ondansetron 4 mg iv was given to patients of Group III at the end of surgery and the rest of the patients received a placebo. The plasters were removed six hours after transferring the patients to the postoperative unit. Criteria were fixed for the administration of rescue antiemetics (ondansetron 4 mg iv). PONV and the requirement for rescue antiemetics were recorded by a blinded observer.R Re es su ul lt ts s: : The incidence of PONV and the requirement for rescue antiemetics were significantly lower in both the acustimulation and ondansetron groups at six hours. At 24 hr there was a reduction in the requirement for rescue medication in the ondansetron group. C Co on nc cl lu us si io on n: : Stimulation of the P6 acupoint with capsicum plaster is an effective method for prevention of PONV after middle ear surgery and its efficacy is comparable to ondansetron for the first six hours after surgery. Objectif : Comparer l'efficacité de la stimulation de l'acupoint P6 avec un emplâtre de Capsicum et l'administration iv d'ondansétron pour la prévention des nausées et vomissements postopératoires (NVPO). Méthode : Cent vingt hommes et femmes, d'état physique ASA I-II, devant subir une opération de l'oreille moyenne sous anesthésie générale, ont participé à l'étude randomisée, prospective, à double insu et contrôlée par placebo. La technique anesthésique a été normalisée. Les patients ont été répartis en trois groupes. Le groupe I était le groupe témoin. Un emplâtre de Capsicum (1 × 1cm) a été appliqué à l'acupoint P6 sur les deux avant-bras 30 min avant l'induction de l'anesthésie chez les patients du groupe II. Les patients des groupes I et III ont reçu un emplâtre adhésif inactif au même site. Une dose de 4 mg d'ondansétron iv a été administrée aux patients du groupe III à la fin de l'opération et le reste des patients a reçu un placebo. Les emplâtres ont été enlevés six heures après le transfert à l'unité des soins postopératoires. Les critères ont été fixés pour l'administration d'antiémétiques de secours (4 mg d'ondansétron iv
Background: Safe and effective use of colistin requires robust pharmacokinetic (PK) and pharmacodynamic (PD) data to guide dosing. Aim: To evaluate the pharmacokinetics of colistimethate sodium and colistin in critically ill patients and correlate with clinical efficacy and renal function. Materials and Methods: Twenty critically ill adult patients with colistin-susceptible multidrug-resistant (MDR) infections and normal renal function treated with intravenous colistimethate sodiumat a 9 million units (270 mg CBA) loading dose followed by maintenance (MD) of 3 million units t.i.d, 24 hours laterwere evaluated for clinical cure (CC) at the end of therapy. Patient characteristics and plasma colistin levels at 0, 0.5, 1, 2, 4, 8 and 12 hours after the loading dose and at 1, 2 and 8 hours after the eighth and ninth infusion of MD were evaluated. Colistimethate sodium and colistin levels were measured by high-performance liquid chromatography and tandem mass spectrometry (HPLC-MS/MS). Results: Among the 20 patients who were evaluated, 60% had pneumonia. Predominant pathogens were Klebsiella pneumoniae and Acinetobacter spp. Clinical cure was 50% (10/20). Mean peak loading dose concentrations were 3 AE 1.1 mg/L (1.75-5.14) and 2.37 AE 1.2 mg/L (1.52-5.54) for 'cure' and 'failure' groups, respectively (p = 0.13), while mean steady-state (Cssavg) concentrations were 2.25 AE 1.3 mg/L and 1.78 AE 1.1 mg/L in 'cure' and 'failure' groups, respectively (p = 0.19). Nephrotoxicity was 5% on day 7 of therapy. However, bacteriological cure could not be correlated with PK/PD. Conclusions: Subtherapeutic Cssavg with clinical failure and lower efficacy without significant nephrotoxicity highlights the need for therapeutic drug monitoring to guide colistin dosing.
In many parts of the world, including in India, pharmacist roles in antimicrobial stewardship (AMS) programmes remain unexplored. We describe the evolution and effect of the role of adding clinical pharmacists to a multidisciplinary AMS at a tertiary care teaching hospital in Kerala, India. Through effective leadership, multidisciplinary AMS (February 2016) and antitubercular therapy (ATT) stewardship programmes (June 2017) were established. Clinical pharmacists were introduced as core members of the programmes, responsible for the operational delivery of key stewardship interventions. Pharmacy-led audit and feedback monitored the appropriateness of antimicrobial prescriptions and compliance to AMS/ATT recommendations. Between February 2016 and January 2017, 56% (742/1326) of antimicrobial prescriptions were appropriate, and 54% (318/584) of recommendations showed compliance. By the third year of the AMS, appropriateness increased to 80% (1752/2190), and compliance to the AMS recommendations to 70% (227/325). The appropriateness of ATT prescriptions increased from a baseline of 61% (95/157) in the first year, to 72% (62/86, June 2018–February 2019). The compliance to ATT recommendations increased from 42% (25/60) to 58% (14/24). Such a model can be effective in implementing sustainable change in low- and middle-income countries (LMICs) such as India, where the shortage of infectious disease physicians is a major impediment to the implementation and sustainability of AMS programmes.
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