701: Adjunct Low-Dose Ketamine Infusion in Critically Ill Patients at a Saudi Hospital (ATTAINMENT Trial)

Abstract

INTRODUCTION: A noticeable interest in ketamine infusion for sedation management has developed among critical care physicians for critically ill patients The Analgo-sedative adjuncT keTAmine Infusion iN Mechanically vENTilated ICU patients (ATTAINMENT) trial aims to assess the effect and safety of adjunct low-dose continuous infusion of ketamine as an analgo-sedative compared to standard of care (SOC) in critically ill patients on mechanical ventilation (MV) for ≥ 24 h METHODS: This trial is a prospective, randomized, active controlled, open-label, pilot, feasibility study of adult intensive care unit (ICU) patients (> 14 years old) on MV at King Faisal Specialist Hospital and Research Center, Saudi Arabia, and will enroll 80 patients Patients was randomized post-intubation into two groups: the intervention group received an adjunct lowdose ketamine infusion plus SOC administered over a period of 48 h at a fixed infusion rate of 2 μg/kg/min (0 12 mg/kg/h) in day 1 followed by 1 μg/kg/min (0 06 mg/kg/h) in day 2 The control group received SOC (propofol and/or fentanyl and/or midazolam) according to our sedation and analgesia protocol as clinically appropriate The primary outcome is MV duration until ICU discharge, death, extubation, or 28 days post-randomization, whichever comes first RESULTS: As of 25 July 2020, a total of 65 patients had been enrolled We expect to complete the recruitment by 31 December 2020 Recruitment rate has been slowed down due to COVID-19 pandemic An Interim analysis was conducted and showed 45% were in medical ICU, 35 % in surgical ICU, and 20 % in transplant/oncology ICU, range SOFA 2-18, and APACHE II 7-39 About 70 % of the patients was extubated within 28 days post-randomization to ketamine compared to 50 % randomized to SOC The percentage of the patient at goal RASS in 48 hours is 61 11 % in ketamine vs 57 89 % in SOC No significant difference between the 2 arms in 28 days mortality CONCLUSIONS: The findings of this pilot trial will justify further investigation for the role of adjunct low-dose ketamine infusion as an analgo-sedative agent in a larger, multicenter, randomized controlled trial The trial is registered at ClinicalTrials gov: NCT04075006, Saudi Food and Drug Authority: SCTR #19063002, and Current controlled trials: ISRCTN14730035