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Trial registered on ANZCTR


Registration number
ACTRN12620000719932
Ethics application status
Approved
Date submitted
28/04/2020
Date registered
2/07/2020
Date last updated
2/07/2020
Date data sharing statement initially provided
2/07/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Remi-Fent1 Study: A Comparison of Remifentanil and Fentanyl in Mechanically Ventilated Patients
Scientific title
Remi-Fent 1: A Feasiblity study of Remifentanil vs Fentanyl in Mechanically Ventilated Patients
Secondary ID [1] 300815 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health conditions which impact on patency of the airway
- airway obstruction from intrinsic and extrinsic sources
316701 0
Health conditions which affect the ability of the patient to protect their airway
- decreased GCS for whatever reason
317614 0
Respiratory failure
- issues with oxygenation or ventilation
317616 0
Need to reduce oxygen consumption and to optimise oxygen delivery
- severe sepsis
317617 0
Control refractory seizures 317618 0
Prevent secondary brain injury 317619 0
Condition category
Condition code
Anaesthesiology 315692 315692 0 0
Anaesthetics
Cardiovascular 315693 315693 0 0
Coronary heart disease
Emergency medicine 315694 315694 0 0
Resuscitation
Infection 315695 315695 0 0
Other infectious diseases
Inflammatory and Immune System 315696 315696 0 0
Other inflammatory or immune system disorders
Neurological 315700 315700 0 0
Epilepsy
Neurological 315701 315701 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Remifentanil infusion via intravenous route will be provided for a minimum duration of 24 hours and continued until the patient no longer requires mechanical ventilation.
Infusion rate will start at 6-9 mcg/kg/hr and be titrated by the ICU nurse as per the target Richmond Agitation-Sedation Scale (RASS), and assessment of pain and discomfort
Intervention code [1] 317145 0
Treatment: Drugs
Comparator / control treatment
The control treatment (Fentanyl infusion) via intravenous route will be provided for a minimum duration of 24 hours and continued until the patient no longer requires mechanical ventilation.
Initial bolus dose of 0.25- 2 mcg/kg as per the medical officer's discretion, followed by continuous intravenous infusion 0.7-10 mcg/kg/hr, titrated by the ICU nurse as per the target Richmond Agitation-Sedation Scale (RASS), and assessment of pain and discomfort
Control group
Active

Outcomes
Primary outcome [1] 323256 0
Number of patients recruited
- assessed by tallying the number of patients recruited within the planned period. This will be calculated from the enrollment log in the study database
Timepoint [1] 323256 0
Planned recruitment period is 12-18 months post recruitment commencement
Primary outcome [2] 323257 0
Compliance of use of the study drug >90%
- patient medical records detailing the drugs given to the patient for sedation and ETT tolerance
- patient medical records to determine the number of patients who were prematurely ceased on the study protocol
Timepoint [2] 323257 0
28 days post intervention commencement
Secondary outcome [1] 381323 0
Quality of life at 6 months using the EQ-5D-5L questionnaire. This will be conducted by email or post or over the phone, depending on the patient's preference.
Timepoint [1] 381323 0
180 days post intervention commencement
Secondary outcome [2] 383798 0
To measure the cost of administering for the study medications in the 2 groups. This is estimated from the cumulative cost per patient multiplied by total number of patients in each group/
Timepoint [2] 383798 0
Cumulative dose of the opioid is calculated for each patient when the patient gets extubated.

Eligibility
Key inclusion criteria
a. Patient intubated and receiving mechanical ventilation
b. Treating clinician expects that the patient will remain intubated until the day after tomorrow (unlikely to be extubated the following day)
c. Patient requires immediate ongoing opioid analgesic infusion for comfort, safety, and to facilitate the delivery of life support measures
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. Patient is pregnant and/or lactating
b. Has been intubated (excluding time spent intubated within an operating theatre or transport) for greater than 12 hours in an intensive care unit
c. Known sensitivity to any of the study medications or the constituents of the study medications

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis
1. The primary outcomes will be stated as numbers and percentages.
2. The secondary outcomes will be compared using Mann-Whitney U-test for continuous variables and Fishers Exact test for categorical variables.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16139 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 29668 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 305271 0
Hospital
Name [1] 305271 0
Nepean Intensive Care Unit
Address [1] 305271 0
Intensive Care Unit
Level 2, North Block
Nepean Hospital
Derby Street
Kingswood, NSW
2749
Country [1] 305271 0
Australia
Primary sponsor type
Individual
Name
Arvind Rajamani
Address
Intensive Care Unit
Level 2, North Block
Nepean Hospital
Derby Street
Kingswood, NSW
2749
Country
Australia
Secondary sponsor category [1] 306254 0
None
Name [1] 306254 0
Address [1] 306254 0
Country [1] 306254 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305616 0
Nepean Hospital HREC
Ethics committee address [1] 305616 0
Level 5
South Block
Nepean Hospital
Kingswood NSW 2747
Postal Address:
PO Box 63
Penrith NSW 2751
Ethics committee country [1] 305616 0
Australia
Date submitted for ethics approval [1] 305616 0
10/02/2020
Approval date [1] 305616 0
30/04/2020
Ethics approval number [1] 305616 0
2020/ETH00311

Summary
Brief summary
The primary aim of this study is to determine the feasibility of conducting an RCT of remifentanil versus fentanyl for opioid analgesic infusion in invasively ventilated patients who are expected to require mechanical ventilation for longer than 24 hours.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100970 0
Dr Arvind Rajamani
Address 100970 0
Intensive Care Unit
Level 2, North Block
Nepean Hospital
Derby Street
Kingswood, NSW
2749
Country 100970 0
Australia
Phone 100970 0
+61247342000
Fax 100970 0
Email 100970 0
rrarvind@hotmail.com
Contact person for public queries
Name 100971 0
Dr Arvind Rajamani
Address 100971 0
Intensive Care Unit
Level 2, North Block
Nepean Hospital
Derby Street
Kingswood, NSW
2749
Country 100971 0
Australia
Phone 100971 0
+61247342000
Fax 100971 0
Email 100971 0
rrarvind@hotmail.com
Contact person for scientific queries
Name 100972 0
Dr Arvind Rajamani
Address 100972 0
Intensive Care Unit
Level 2, North Block
Nepean Hospital
Derby Street
Kingswood, NSW
2749
Country 100972 0
Australia
Phone 100972 0
+61247342000
Fax 100972 0
Email 100972 0
rrarvind@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
For confidentiality and consent reasons
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7798 0
Study protocol
Citation [1] 7798 0
Link [1] 7798 0
Email [1] 7798 0
rrarvind@hotmail.com
Other [1] 7798 0
By emailing the Principal Investigator
Attachment [1] 7798 0
Type [2] 7799 0
Statistical analysis plan
Citation [2] 7799 0
Link [2] 7799 0
Email [2] 7799 0
rrarvind@hotmail.com
Other [2] 7799 0
By emailing the Principal Investigator
Attachment [2] 7799 0
Type [3] 7800 0
Informed consent form
Citation [3] 7800 0
Link [3] 7800 0
Email [3] 7800 0
rrarvind@hotmail.com
Other [3] 7800 0
By emailing the Principal Investigator
Attachment [3] 7800 0
Type [4] 7801 0
Ethical approval
Citation [4] 7801 0
Link [4] 7801 0
Email [4] 7801 0
rrarvind@hotmail.com
Other [4] 7801 0
By emailing the Principal Investigator
Attachment [4] 7801 0
Summary results
No Results