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.