Analgosedative adjuncT keTAmine Infusion iN Mechanically vENTilated ICU Patients

NCT04075006 | Completed Phase 3

• 3 other identifiers: 2191187SCTR #19063002ISRCTN14730035
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the efficacy and safety of a low dose ketamine infusion used in combination of standard of care in critically ill patients to test whether ketamine can help to shorten the time of being in breathing tube and ventilator compared to the standard of care alone.

Conditions

Critical Illness; Sedation; Mechanical Ventilation

Keywords

Ketamine, standard of care, critically ill, mechanically ventilation, ATTAINMENT, propofol, Fentanyl , midazolam , delirium, vasopressors

Outcome Measures

Primary Outcomes (1)

• Duration of Mechanical Ventilation

  To assess whether ketamine can help to shorten the time of being in breathing tube and ventilator (duration of mechanical ventilation )

  From Intubation to extubation date and off Mechanical Ventilation or until ICU discharge, death, or 28 days post randomization whichever occurs first.

Secondary Outcomes (12)

• Cumulative Sedation Dosages

  First 48 hours after randomization

• Dexmedetomidine use

  First 48 hours after randomization

• Richmond Agitation Sedation Score (RASS)

  First 48 hours after randomization

• Pain score

  First 48 hours after randomization

• Vasopressor Medication Dosages

  First 48 hours after randomization.

Other Outcomes (4)

• Incidence of Delirium

  48 hours after randomization

• The use of anti-psychotics

  48 hours after randomization

• Use of Physical restraints

  48 hours after randomization

Study Arms (2)

Ketamine Group

EXPERIMENTAL

adjunct low dose continuous infusion ketamine in addition to the standard of care. Ketamine will be given at a fixed infusion rate of 0.12 mg/kg/hr (2 µg/kg/min) in the first 24 hours followed by 0.06 mg/kg/hr (1 µg/kg/min) in the second 24 hours, then discontinued

Drug: Ketamine

Control Group

NO INTERVENTION

Standard of care in the ICU including propofol and / or fentanyl and/or midazolam according to KFSHRC sedation and analgesia protocol.

Interventions

Ketamine DRUG

standard of care plus Ketamine infusion at a fixed rate of 0.12 mg/kg/hr (2 µg/kg/min) in the first 24 hours followed by 0.06 mg/kg/hr (1 µg/kg/min) in the second 24 hours, then discontinued

Ketamine Group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult ICU (Medical or surgical) patients (\> 14 years old)
• Mechanically ventilated within the previous 24 hours and expected to remain intubated for more than 24 hours.
• The patient requires ongoing sedative medication
• No objection from the ICU attending MD for enrollment

You may not qualify if:

• Patients with a history of dementia or psychiatric disorders or on any anti-psychotics or anti-depressants medications at home
• Pregnancy
• Age \< 14 years old
• Expected to need mechanical ventilation less than 24 hours
• Known hypersensitivity to ketamine
• Patient on dexmedetomidine as primary sedative agent prior to randomization
• Patients with cardiogenic shock, heart failure, myocardial infarction
• History of end-stage liver disease.
• Proven or suspected primary neurological injury (traumatic brain injury, ischemic stroke, intracranial hemorrhage, spinal cord injury, anoxic brain injury)
• Patients with persistent heart rate (HR) \> 150 bpm or systolic blood pressure (SBP) \>180 mmHg
• Patients who assigned as do-not-resuscitate order (DNR) or expected to die within 24 hours
• Patients on ECMO
• Patients with status epilepticus patients who are receiving the ketamine infusion for refractory status epilepticus
• Proven or suspected status asthmaticus
• Patients with expected targeted RASS of -5 such as patients on continuous infusion neuromuscular blockade

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

King Faisal Specialist Hospital and Research Centre

Riyadh, 11211, Saudi Arabia

Location

Related Publications (2)

• Amer M, Maghrabi K, Bawazeer M, Alshaikh K, Shaban M, Rizwan M, Amin R, De Vol E, Baali M, Altewerki M, Bano M, Alkhaldi F, Alenazi S, Hijazi M. Adjunctive ketamine for sedation in critically ill mechanically ventilated patients: an active-controlled, pilot, feasibility clinical trial. J Intensive Care. 2021 Aug 30;9(1):54. doi: 10.1186/s40560-021-00569-1.

  PMID: 34462007 DERIVED

• Bawazeer M, Amer M, Maghrabi K, Alshaikh K, Amin R, Rizwan M, Shaban M, De Vol E, 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. Trials. 2020 Mar 20;21(1):288. doi: 10.1186/s13063-020-4216-4.

  PMID: 32197636 DERIVED

MeSH Terms

Conditions

Critical Illness; Delirium

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Intensivist

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: August 30, 2019
• Study Start: August 28, 2019
• Primary Completion: May 6, 2021
• Study Completion: May 6, 2021
• Last Updated: May 7, 2021

Record last verified: 2021-05

Locations

SA (1)