Adjunct low-dose ketamine infusion vs standard of care in mechanically ventilated critically ill patients at a Tertiary Saudi Hospital (ATTAINMENT Trial): study protocol for a randomized, prospective, pilot, feasibility trial.

Publication date: Mar 20, 2020

A noticeable interest in ketamine infusion for sedation management has developed among critical care physicians for critically ill patients. The 2018 Pain, Agitation/sedation, Delirium, Immobility, and Sleep disruption guideline suggested low-dose ketamine infusion as an adjunct to opioid therapy to reduce opioid requirements in post-surgical patients in the intensive care unit (ICU). This was, however, rated as conditional due to the very low quality of evidence. Ketamine has favorable characteristics, making it an especially viable alternative for patients with respiratory and hemodynamic instability. 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 in critically ill patients on mechanical ventilation (MV) for ? 24?h.

This trial is a prospective, randomized, active controlled, open-label, pilot, feasibility study of adult ICU patients (>?14?years old) on MV. The study will take place in the adult ICUs in the King Faisal Specialist Hospital and Research Center (KFSH&RC), Riyadh, Saudi Arabia, and will enroll 80 patients. Patients will be randomized post-intubation into two groups: the intervention group will receive an adjunct low-dose continuous infusion of ketamine plus standard of care. Ketamine will be administered over a period of 48?h at a fixed infusion rate of 2??g/kg/min (0.12?mg/kg/h) in the first 24?h followed by 1??g/kg/min (0.06?mg/kg/h) in the second 24?h. The control group will receive standard of care in the ICU (propofol and/or fentanyl and/or midazolam) according to the KFSH&RC 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.

The first patient was enrolled on 1 September 2019. As of 10 October 2019, a total of 16 patients had been enrolled. We expect to complete the recruitment by 31 December 2020. The findings of this pilot trial will likely justify further investigation for the role of adjunct low-dose ketamine infusion as an analgo-sedative agent in a larger, multicenter, randomized controlled trial.

ClinicalTrials.gov: NCT04075006. Registered on 30 August 2019. Current controlled trials: ISRCTN14730035. Registered on 3 February 2020.

Open Access PDF

Bawazeer, M., Amer, M., Maghrabi, K., Alshaikh, K., Amin, R., Rizwan, M., Shaban, M., De Vol, E., and Hijazi, M. Adjunct low-dose ketamine infusion vs standard of care in mechanically ventilated critically ill patients at a Tertiary Saudi Hospital (ATTAINMENT Trial): study protocol for a randomized, prospective, pilot, feasibility trial. 04806. 2020 Trials (21):1.

Concepts Keywords
Analgesia Sedation analgesia protocol
Conditional Pain
Control Group Mechanical ventilation
Critical Care Drugs
Extubation Psychoactive drugs
Fentanyl Medical specialties
Hemodynamic RTT
Infusion General anesthetics
Intensive Care Unit Analgesics
Intubation Euphoriants
Ketamine Ketamine
Mechanical Ventilation Midazolam
Mechanically Ventilated Propofol
Midazolam Sedation
Opioid
Propofol
Protocol
Randomization
Randomized Controlled Trial
Riyadh
Saudi Arabia
Sedation
Sedative
Tertiary

Semantics

Type Source Name
drug DRUGBANK Ketamine
disease MESH critically ill
disease MESH Delirium
disease MESH Sleep
drug DRUGBANK Propofol
drug DRUGBANK Fentanyl
drug DRUGBANK Midazolam
disease MESH death
pathway REACTOME Reproduction
drug DRUGBANK Trestolone
drug DRUGBANK Morphine
disease MESH hypoventilation
disease MESH pruritus
drug DRUGBANK Dexmedetomidine
drug DRUGBANK Benzodiazepine
disease MESH opioid induced constipation
disease MESH tachycardia
disease MESH hypertension
disease MESH hallucinations
disease MESH dementia
disease MESH coma
disease MESH Confusion
disease MESH bronchospasm
disease MESH hypotension
drug DRUGBANK Acetylsalicylic acid
drug DRUGBANK Coenzyme M
disease MESH hypersalivation
disease MESH hypersensitivity
disease MESH cardiogenic shock
disease MESH myocardial infarction
disease MESH liver failure
disease MESH edema
disease MESH status epilepticus
disease MESH status asthmaticus
disease MESH arterial pressure
disease MESH renal
disease MESH Infection
disease MESH pathology
disease MESH pneumonia
disease MESH risk factors
drug DRUGBANK Oxygen
disease MESH community
drug DRUGBANK Hydromorphone
disease MESH Stroke volume
disease MESH Stroke
drug DRUGBANK Etoperidone
drug DRUGBANK Imatinib
drug DRUGBANK Sufentanil
disease MESH sepsis
drug DRUGBANK Lorazepam

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