Analgosedative adjuncT keTAmine Infusion iN Mechanically vENTilated ICU Patients (ATTAINMENT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04075006|
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : September 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Critical Illness Sedation Mechanical Ventilation||Drug: Ketamine||Phase 3|
Ketamine is used to produce sedation and relieve pain to minimize discomfort while a breathing tube placed in trachea (windpipe) and a machine (ventilator) used in the ICU. Several publications have shown that a low-dose ketamine in combination to opioids has been used to relieve acute pain after surgery. Ketamine has a favorable characteristics including bronchodilation, increase in blood pressure, does not cause constipation , maintain respiratory reflexes (respiratory spontaneous responses) make it an especially viable alternative for patients with unstable respiratory and hemodynamic function. However, the majority of these trials are conducted in a surgical ICU setting, retrospective in nature or randomized controlled clinical trials focusing on comparison of ketamine to placebo or two study drugs (e.g. ketamine versus opioid), despite the fact that most ICU patients are sedated with a combination of drugs. Moreover, the majority of those trials has a limited focus on patient-centered outcomes, as the primary outcome.
The aim of this study is to assess weather ketamine can help to shorten the time of being in breathing tube and ventilator (duration of mechanical ventilation). This is a prospective, randomized, active controlled, open-label pilot study to assess the efficacy and safety of Analgo-sedative adjuncT keTAmine Infusion iN Mechanically vENTilated ICU patients (ATTAINMENT trial). The study hypothesis is that low dose ketamine infusion will reduce the duration of mechanical ventilation with an acceptable safety profile compared to standard of care. The study will include adult ICU patients (> 14 years old) admitted to KFSHRC ICUs within the previous 24 hours, placed on the ventilator, expected to need breathing tube for longer than 24 hours and placed on KFSHRC sedation and pain protocol. Patients will be separated to 2 groups: The intervention group: will receive a low dose ketamine infusion used in combination of standard of care. Ketamine will be given as intravenous infusion at a fixed infusion rate 0.12 mg/kg/hr (2 µg/kg/min) in 1st 24hr followed by 0.06 mg/kg/hr (1 µg/kg/min) in 2nd 24hr. The control group which will receive standard of care in the ICU including propofol and / or fentanyl and/or midazolam according to KFSHRC ICU sedation and analgesia protocol as chosen by the treating clinician.The randomization process is computer-generated using block randomization with a size of 8 patients in each block.
The number of the subjects to be enrolled in this study is 80 and duration of the subject's participation is 48hrs. Patients will be assessed for duration of mechanical ventilation as a primary outcome.
Study medication (i.e. ketamine) will be administered until one the following occurs:
- Patient has received ketamine for 48 hours (intended duration if the study), or
- If ICU team deemed excessive sedation persisted after holding or decreasing the sedating medication and patient not on target sedation score called RASS,
- Patient died or goal of care changed to comfort care
- Patient extubated and sedation weaned off ,
- an adverse event potentially attributable to the study drug is experienced by a patient that is deemed, in the opinion of the investigative team to warrant discontinuation of therapy such as fast heart beat persist >150 beat per min for more than 3 hours, high systolic blood pressure persist > 180 for more than 3 hours, severe agitation and pulling off breathing tube or lines, and aggressive behavior to the nursing staff.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adjunct Low Dose Ketamine Infusion Versus Standard of Care in Mechanically Ventilated Critically Ill Patients at a Tertiary Saudi Hospital: Randomized, Prospective, Pilot Trial|
|Actual Study Start Date :||August 28, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Ketamine Group
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
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
No Intervention: Control Group
Standard of care in the ICU including propofol and / or fentanyl and/or midazolam according to KFSHRC sedation and analgesia protocol.
- Duration of Mechanical Ventilation [ Time Frame: From Intubation to extubation date and off Mechanical Ventilation or until ICU discharge, death, or 28 days post randomization whichever occurs first. ]To assess whether ketamine can help to shorten the time of being in breathing tube and ventilator (duration of mechanical ventilation )
- Cumulative Sedation Dosages [ Time Frame: First 48 hours after randomization ]To compare the cumulative dose of pain and sedative medications.
- Dexmedetomidine use [ Time Frame: First 48 hours after randomization ]To compare the number of patients started on dexmedetomidine.
- Richmond Agitation Sedation Score (RASS) [ Time Frame: First 48 hours after randomization ]To compare The number of patients are in RASS score goal.
- Pain score [ Time Frame: First 48 hours after randomization ]
To compare The number of patients are in pain score goal. We will use the KFSHRC pain scale being used in our ICU.
For Adult communicative patients, we will use a scale from 0-10. The "0" indicates "No pain" and "10" indicates "severe pain". Values between 1-3 indicate mild pain, values between 4-6 indicate moderate pain while values between 7-10 indicate severe pain.
For non-communicative patients, A scale is composed of five categories: Physiology, Facial expressions, Activity (movement), Guarding And Respiratory, will be used. Each Category has a scale 0-2, then the total score is calculated and should be between 0-10. Values between 0-2 indicate no pain, values 3-6 indicate moderate pain while values between 7-10 indicate severe pain.
- Vasopressor Medication Dosages [ Time Frame: First 48 hours after randomization. ]To compare vasopressor requirement.
- Hospital Length of Stay (LOS) [ Time Frame: Throughout study completion (1 year) ]To compare hospital LOS
- ICU Length of stay (LOS) [ Time Frame: Throughout study completion (1 year) ]To compare ICU LOS
- Tracheostomy [ Time Frame: 28 days after randomization ]Tracheostomy rate
- Unplanned extubation [ Time Frame: 28 days after randomization ]Rate of unplanned extubation
- Re-intubation rate [ Time Frame: 28 days after randomization ]Rate of unplanned and unexpected re-intubation
- Incidence of Delirium [ Time Frame: 48 hours after randomization ]Rate of positive Confusion Assessment Method in Intensive Care Unit (CAM-ICU)
- The use of anti-psychotics [ Time Frame: 48 hours after randomization ]Rate of using anti-psychotics for confirmed ICU-acquired delirium
- Use of Physical restraints [ Time Frame: 48 hours after randomization ]Use of physical restraints
- Mortality [ Time Frame: 28 days after randomization ]Death that occurs during 28 days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075006
|Contact: Mohammed Bawazeer, MD, FRCSC, FACS||+966112162919 ext email@example.com|
|Contact: Marwa Amer, PharmD, BCPS, BCCCP||+966112162919 ext firstname.lastname@example.org|
|King Faisal Specialist Hospital and Research Centre||Recruiting|
|Riyadh, Saudi Arabia, 11211|
|Contact: Abeer Omar +966114424528 email@example.com|
|Principal Investigator: Mohammed Bawazeer, MD, FRCSC, FACS|
|Principal Investigator: Marwa Amer, PharmD, BCPS, BCCCP|
|Sub-Investigator: Khalid Maghrabi, MD, Chairman|
|Sub-Investigator: Mohammed Hijazi, MD, Consultant Intensivist|
|Sub-Investigator: Kamel Al-Sheikh, MD, Assistant Consultant|
|Sub-Investigator: Muhammad Rizwan, MD, Assistant Consultant|
|Sub-Investigator: Rashid Amin, PharmD, BCPS, BCCCP|
|Sub-Investigator: Edward De Vol, Chairman, Biostat, Epidem|
|Sub-Investigator: Mohammad Shaban, MD, Assistant Consultant|