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Trial registered on ANZCTR


Registration number
ACTRN12621000943842
Ethics application status
Approved
Date submitted
2/06/2021
Date registered
19/07/2021
Date last updated
19/07/2021
Date data sharing statement initially provided
19/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effectiveness of Prophylactic Hypotension Avoidance iN arThrOplasty using Midodrine (PHANTOM) pilot trial
Scientific title
Investigating the effectiveness, feasibility and safety of Prophylactic Hypotension Avoidance iN arThrOplasty using Midodrine (PHANTOM) pilot trial in Adults
Secondary ID [1] 301869 0
None
Universal Trial Number (UTN)
Trial acronym
PHANTOM Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgery 319183 0
Hypotension 319184 0
Hip Arthroplasty 322179 0
Knee Arthroplasty 322181 0
Condition category
Condition code
Cardiovascular 317151 317151 0 0
Other cardiovascular diseases
Surgery 317152 317152 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Random allocation to either oral Placebo or oral 15mg Midodrine 1hour before induction of anaesthesia.
Postoperatively allocated Placebo or oral 10mg Midodrine every 4 hours for the first 24 hours if Blood Pressure is below 140mmHg.
The allocation will be by the use of a random number generator.
Intervention code [1] 318681 0
Treatment: Drugs
Comparator / control treatment
Placebo - microcellulose capsule
Control group
Placebo

Outcomes
Primary outcome [1] 325228 0
Effectiveness of Midodrine - Highest absolute Blood Pressure values in PACU, after study drug dosage measured in mmHg via sphygmomanometer
Timepoint [1] 325228 0
Measured every 2 hours for up to 24hrs postoperatively
Primary outcome [2] 325229 0
Feasibility of trial measured by annualised recruitment rate as assessed via study records and event rate at the conclusion of the trial.
Timepoint [2] 325229 0
Annualised recruitment rate
Primary outcome [3] 325230 0
Safety- Rate of intervention for hypertension as assessed via patient medical records;
Timepoint [3] 325230 0
72 hours post-operatively,
Secondary outcome [1] 387290 0
Medical interventions required for the treatment of hypo or hypertension via patient medical records .
Timepoint [1] 387290 0
72 hours post-operatively
Secondary outcome [2] 387291 0
Number of MET calls via patient medical records
Timepoint [2] 387291 0
72 hours post-operatively
Secondary outcome [3] 387292 0
Number of unplanned ICU or HDA admissions via patient medical records
Timepoint [3] 387292 0
72 hours post-operatively
Secondary outcome [4] 387293 0
Maximum intraoperative blood pressure reading (systolic and diastolic) measured in mmHg via
sphygmomanometer
Timepoint [4] 387293 0
Intraoperative
Secondary outcome [5] 387294 0
Minimum intraoperative blood pressure reading (systolic and diastolic) measured in mmHg via
sphygmomanometer
Timepoint [5] 387294 0
Intraoperative time period
Secondary outcome [6] 387295 0
Maximum postoperative blood pressure reading (systolic and diastolic) measured in mmHg via sphygmomanometer
Timepoint [6] 387295 0
72 hours post-operatively
Secondary outcome [7] 387296 0
Minimum postoperative blood pressure reading (systolic and diastolic) measured in mmHg via sphygmomanometer
Timepoint [7] 387296 0
72 hours post-operatively
Secondary outcome [8] 387298 0
Duration of each hypotensive or hypertensive episode through review of patient medical records
Timepoint [8] 387298 0
72 hours post-operatively
Secondary outcome [9] 387300 0
Time weighted average duration of blood pressure excursion through review of patient medical records
Timepoint [9] 387300 0
72 hours post-operatively
Secondary outcome [10] 387301 0
Assessing the Incidence of myocardial injury / infarction through review of patient medical records
Timepoint [10] 387301 0
72 hours post-operatively
Secondary outcome [11] 387302 0
A Delta blood test of NT-pro-BNP levels
Timepoint [11] 387302 0
72 hours post-operatively
Secondary outcome [12] 396397 0
Total fluid volumes administered through review of patient medical records
Timepoint [12] 396397 0
24 hours post-operatively
Secondary outcome [13] 396398 0
Transfusion required through review of patient medical records
Timepoint [13] 396398 0
72 hours post-operatively
Secondary outcome [14] 396399 0
Delta Blood test measuring Creatinine levels
Timepoint [14] 396399 0
At Day 2 post-operatively
Secondary outcome [15] 396400 0
Composite Safety end points, including:
#Stroke
#Arrhythmia
#Cardiac failure
#Clinically significant bleeding.
through review of patient medical records
Timepoint [15] 396400 0
72 hours post-operatively
Secondary outcome [16] 396401 0
Difference between predicted surgical outcomes and actual surgical outcomes (as determined by the Revised Cardiac Risk Index, NSQIP and NZRisk tools and through review of patient medical records) (This is a composite secondary outcome)
Timepoint [16] 396401 0
72 hours post-operatively
Secondary outcome [17] 396402 0
The difference in the incidence of postoperative delirium (either requiring administration of anti psychotic medication through review of patient medical records or determined by 3D-CAM assessment tool)
Timepoint [17] 396402 0
72 hours post-operatively
Secondary outcome [18] 397328 0
Risk of death at 30 days postoperatively through review of patient medical records)
Timepoint [18] 397328 0
30 days postoperatively
Secondary outcome [19] 398261 0
Safety - Myocardial injury as determined by serum troponin (this is a primary outcome)
Timepoint [19] 398261 0
72 hours post-operatively,

Eligibility
Key inclusion criteria
Patients undergoing elective or emergency arthroplasties, including total hip replacement, hemiarthroplasty or total knee replacement.
ASA 1-4
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to provide informed consent
Hypersensitivity/ Anaphylaxis to Midodrine
Weight under 60kg
Systolic Blood pressure >160mmHg (average of 3 readings)
Cardiac: Supine Hypertension, Congestive Cardiac Failure (Ejection Fraction <40%), Moderate- Severe Aortic Stenosis, Mitral Stenosis, Cardiomyopathy, Global systolic dysfunction (Ejection fraction <40%). Pulmonary Hypertension (Mean Pulmonary Arterial Pressure >25mmHg
Vascular: Known Severe Obliterative Peripheral Vascular Disease
Renal: Dialysis dependent End Stage Renal Disease, eGFR< 45mls/min
Gastrointestinal: Known impaired Gastrointestinal absorption, Patient not likely to be able to take oral medication within the first 24 hours
Neurological: Unsecured cerebral aneurysm, Severe Migraine
Opthalmological: Narrow angle glaucoma, Proliferative Diabetic Retinopathy
Endocrine: Thyrotoxicosis, Phaeochromocytoma


Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes allocation concealment is used, central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Sample size calculations were performed in relation to the effectiveness outcome only. Based upon the data generated from our initial experience with midodrine in RPH, to detect a systolic blood pressure difference in PACU of 100 mmHg in placebo arm and 115 mmHg in midodrine arm, assuming standard deviation of 30 mmHg (alpha 0.05, 90% power), requires 166 patients. This sample size is also more than sufficient to simultaneously evaluate the feasibility and safety outcomes.

Recruitment
Recruitment status
Not yet 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)
WA
Recruitment hospital [1] 17703 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 31557 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 306291 0
Hospital
Name [1] 306291 0
Anaesthetic Research, Department of Anaesthesia and Pain Management, Royal Perth Hospital
Address [1] 306291 0
Box X2213 GPO
PERTH, WA, 6847
Country [1] 306291 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
Box X2213 GPO
PERTH WA Australia 6847
Country
Australia
Secondary sponsor category [1] 306785 0
None
Name [1] 306785 0
Address [1] 306785 0
Country [1] 306785 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306508 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 306508 0
South Metropolitan Health Service Executive
Level 2, Education Building, Fiona Stanley Hospital
14 Barry Marshall Parade
MURDOCH Western Australia 6150
Ethics committee country [1] 306508 0
Australia
Date submitted for ethics approval [1] 306508 0
29/09/2020
Approval date [1] 306508 0
09/11/2020
Ethics approval number [1] 306508 0
RGS0000004372

Summary
Brief summary
The PHANTOM trial is a randomised, placebo controlled, blinded pilot trial looking at the use of prophylactic and perioperative Midodrine, in patients undergoing elective and emergency arthroplasties. This will determine if it is safe and effective in preventing clinically significant hypotension, intraoperatively and post-operatively, within a 24hr period.
Patients will be followed up for 1 month following the index surgical procedure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104102 0
Prof Tomas Corcoran
Address 104102 0
Department of Anaesthesia and Pain Medicine
Level 4, North Block
Royal Perth Hospital
Wellington Street
Perth Western Australia 6000
Country 104102 0
Australia
Phone 104102 0
+61 892241038
Fax 104102 0
Email 104102 0
tomas.corcoran@health.wa.gov.au
Contact person for public queries
Name 104103 0
Mrs Pauline Coutts
Address 104103 0
Department of Anaesthesia and Pain Medicine
Level 4, North Block
Royal Perth Hospital
Wellington Street
Perth Western Australia 6000
Country 104103 0
Australia
Phone 104103 0
+61 892241036
Fax 104103 0
Email 104103 0
pauline.coutts@health.wa.gov.au
Contact person for scientific queries
Name 104104 0
Prof Tomas Corcoran
Address 104104 0
Department of Anaesthesia and Pain Medicine
Level 4, North Block
Royal Perth Hospital
Wellington Street
Perth Western Australia 6000
Country 104104 0
Australia
Phone 104104 0
+61892241038
Fax 104104 0
Email 104104 0
tomas.corcoran@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results