Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000594628
Ethics application status
Approved
Date submitted
17/05/2023
Date registered
31/05/2023
Date last updated
20/11/2023
Date data sharing statement initially provided
31/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the feasibility and benefits of Ketamine Sedation in Acute Brain Injury
Scientific title
Ketamine Sedation in Acute Traumatic Brain Injury in Adults: A randomized pilot feasibility study.
Secondary ID [1] 309610 0
Nil
Universal Trial Number (UTN)
U1111-1292-5987
Trial acronym
KIBI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury 330009 0
Condition category
Condition code
Injuries and Accidents 326916 326916 0 0
Other injuries and accidents
Neurological 327004 327004 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ketamine delivered via continuous intravenous infusion at 1mg/kg/hr of lean body mass for a maximum of 120hrs (5 days) then ceased. Ketamine is in addition to standard sedation which must include an infusion of GABA agonist medication e.g. Propofol or Mizadolam. Protocol compliance will be monitored via the electronic medical record.
Intervention code [1] 326100 0
Treatment: Drugs
Comparator / control treatment
Standard sedation (no ketamine infusion or placebo) which must include an infusion of GABA agonist medication e.g. Propofol or Mizadolam.
Control group
Active

Outcomes
Primary outcome [1] 334754 0
Feasibility of administering Ketamine for 48hrs via continuous infusion determined by dose of Ketamine administered via patient electronic medical record
Timepoint [1] 334754 0
48hrs post commencement of ketamine infusion
Secondary outcome [1] 421959 0
Cumulative dose of vasoactive medications recorded in patient electronic medical record.
Timepoint [1] 421959 0
Day 7 post enrolment
Secondary outcome [2] 421960 0
Cumulative dose of sedative medications recorded in patient electronic medical record.
Timepoint [2] 421960 0
Day 7 post enrolment
Secondary outcome [3] 421962 0
Incidence of delirium requiring pharmacological management recorded in the electronic medical record
Timepoint [3] 421962 0
Day 14 post enrolment

Eligibility
Key inclusion criteria
First admission to the intensive care unit (ICU) for management of moderate to severe traumatic brain injury with abnormal CT scan, Glasgow Coma Score <12 points and requirement from intracranial pressure monitoring
Clinically stable and sedated with an infusion of GABA agonist medication
Expected period of sedation >72hrs
For full active management
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Documented or suspected hypersensitivity to Ketamine
Known of suspected chronic kidney or liver disease
History of coronary artery disease or evidence of acute coronary syndrome
Admitted for palliative management
Greater than 72hrs elapsed since admission to the ICU

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer sequence generation with permuted blocks. Stratification by age.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/06/2023
Actual
8/08/2023
Date of last participant enrolment
Anticipated
23/05/2025
Actual
Date of last data collection
Anticipated
6/06/2025
Actual
Sample size
Target
40
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24739 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 40360 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 313790 0
Hospital
Name [1] 313790 0
Alfred Research Trusts
Country [1] 313790 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
55 Commercial Rd, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 315692 0
None
Name [1] 315692 0
Address [1] 315692 0
Country [1] 315692 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312958 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 312958 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 312958 0
Australia
Date submitted for ethics approval [1] 312958 0
Approval date [1] 312958 0
23/11/2021
Ethics approval number [1] 312958 0
HREC/75693/Alfred-2021

Summary
Brief summary
Patients with acute traumatic brain injury (TBI) requiring admission to the ICU, commonly receive sedative drugs to reduce the brain’s demand for oxygen and glucose. These patients often also require pain-relieving (analgesic) medications.
Ketamine is a combined sedative and analgesic medication that is not currently used in acute TBI but has the potential to benefit this patient group for several reasons:
1. It can reduce the need for high doses of other sedatives and analgesic drugs which may accumulate or cause low blood pressure
2. It can reduce or eliminate the need for other drug infusions which are required to maintain a normal or high blood pressure during the treatment of TBI
3. It has been shown to reduce the incidence of damaging waves of brain activation that travel across the surface of the brain after severe TBI (Spreading Depolarizations).
This pilot feasibility study aims to demonstrate that using Ketamine sedation is safe in acute TBI patients admitted to the ICU and will establish the methodology for a larger randomised controlled trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126482 0
Prof Andrew Udy
Address 126482 0
Department of Intensive Care and Hyperbaric Medicine
Alfred Hospital
Level 2, 541 St Kilda Rd
Melbourne VIC 3004
Country 126482 0
Australia
Phone 126482 0
+61 438 755 568
Fax 126482 0
Email 126482 0
andrew@udy.com
Contact person for public queries
Name 126483 0
Ms Meredith Young
Address 126483 0
Department of Intensive Care and Hyperbaric Medicine
Alfred Hospital
Level 2, 541 St Kilda Rd
Melbourne VIC 3004
Country 126483 0
Australia
Phone 126483 0
+61390768034
Fax 126483 0
Email 126483 0
m.young@alfred.org.au
Contact person for scientific queries
Name 126484 0
Dr Toby Jeffcote
Address 126484 0
Department of Intensive Care and Hyperbaric Medicine.
Alfred Hospital
Level 2, 541 St Kilda Rd
Melbourne VIC 3004
Country 126484 0
Australia
Phone 126484 0
+61 423 962 386
Fax 126484 0
Email 126484 0
d.jeffcote@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data sharing requests will be reviewed by the management committee
When will data be available (start and end dates)?
3 months after publication with no end date determined.
Available to whom?
Case-by-case basis at the discretion of the Management Committee
Available for what types of analyses?
To achieve the aims in the approved proposal
How or where can data be obtained?
Contact the management committee via Dr Toby Jeffcote - d.jeffcote@alfred.org.au


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.