Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000246987p
Ethics application status
Not yet submitted
Date submitted
4/02/2020
Date registered
26/02/2020
Date last updated
26/02/2020
Date data sharing statement initially provided
26/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Midodrine for the prevention of perioperatIve hypotension
Scientific title
Midodrine for the prevention of perioperatIve hypotension in patients undergoing major surgery
Secondary ID [1] 300441 0
Nil known
Universal Trial Number (UTN)
U1111-1247-7227
Trial acronym
METEORITE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perioperative Hypotension 316103 0
Condition category
Condition code
Anaesthesiology 314388 314388 0 0
Other anaesthesiology
Cardiovascular 314389 314389 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We plan to administer oral Midodrine 15mg, 1 hour pre-operatively and then oral Midodrine 15mg three times daily for 48 hours post-operatively or until the patient is discharged from the hospital. In the case of a recorded systolic blood pressure >150mmHg, oral Midodrine will not be administered until the next planned administration time at which blood pressure can be reassessed. Medication will be prescribed on the hospital's electronic medical record and administration will be unblinded. Administration will only be as an inpatient so a record of administration will exist on the hospital's electronic medical record.
Intervention code [1] 316734 0
Treatment: Drugs
Comparator / control treatment
Standard care as defined as routine postoperative care for patients in our hospital. Specifically no midodrine is used routinely in our hospital and thus will not be administered to the control group. All other elements of postoperative care will be as per the treating team.
Control group
Active

Outcomes
Primary outcome [1] 322743 0
Postoperative hypotension
- Incidence of systolic blood pressure <100mmHg as measured using an automated or manual sphygmomanometer and recorded in the electronic medical record.
Timepoint [1] 322743 0
0-48HRS postoperatively
Primary outcome [2] 322744 0
Postoperative rapid response team call - this is a binary outcome it is either activated or not activated. A rapid response team call is made when a patient meets pre-specified call criteria as outlined in the following article:
Jones DA, DeVita MA, Bellomo R. Rapid-response teams. N Engl J Med 2011; 365: 139-46
Timepoint [2] 322744 0
0-48HRS postoperatively
Secondary outcome [1] 379529 0
Incidence of MAP <65mmHg as measured using an automated or manual sphygmomanometer and recorded in the electronic medical record.
Timepoint [1] 379529 0
0-48HRS postoperatively
Secondary outcome [2] 379530 0
30-day mortality - collected using data-linkage to medical records
Timepoint [2] 379530 0
30 days postoperatively
Secondary outcome [3] 379531 0
Days Alive and Out of Hospital – 30 days (DAOH-30). This outcome is assessed by measuring days alive at 30 days postoperatively and subtracting days stayed in hospital. This information will be collected via data-linkages with electronic medical records.
Timepoint [3] 379531 0
30 days postoperatively
Secondary outcome [4] 379532 0
Total hospital length of stay - This information will be collected via data-linkages with electronic medical records.
Timepoint [4] 379532 0
30 days postoperatively
Secondary outcome [5] 379533 0
Readmission at 30 days - This information will be collected via data-linkages with electronic medical records.
Timepoint [5] 379533 0
30 days postoperatively
Secondary outcome [6] 379534 0
Unplanned critical care admission - This information will be collected via data-linkages with electronic medical records.
Timepoint [6] 379534 0
30 days postoperatively
Secondary outcome [7] 379535 0
Perioperative vasopressor requirement - as measured by doses of individual vasopressor drugs used, for example total milligrams of metaraminol administered. This information will be collected via data-linkages with electronic medical records.
Timepoint [7] 379535 0
48 hours postoperatively
Secondary outcome [8] 379536 0
Perioperative fluid balance measured in millilitres - This information will be collected via data-linkages with electronic medical records.
Timepoint [8] 379536 0
48 hours postoperatively
Secondary outcome [9] 379537 0
Myocardial Injury after Non-cardiac Surgery (MINS) as defined by an elevated serum high-sensitivity troponin T to >20ng/L
Timepoint [9] 379537 0
72 hours postoperatively
Secondary outcome [10] 379538 0
Acute Kidney Injury - as defined by a rise in serum creatinine by 0.3mg/dL or more within 48 hours or an increase in serum creatinine to 1.5 times the baseline or more within the last 7 days or urine output less than 0.5ml/kg for 6 hours
Timepoint [10] 379538 0
30 days postoperatively
Secondary outcome [11] 379539 0
Stroke - as defined by clinical and radiographic evidence of a new cerebrovascular event and diagnosed as such by the treating team and recorded in the medical record.
Timepoint [11] 379539 0
30 days postoperatively
Secondary outcome [12] 379540 0
Surgical site infection - defined as an infection that occurs within 30 days after the operation
and involves the skin and subcutaneous tissue of the incision (superficial incisional) and/or the deep soft tissue (for example, fascia, muscle) of the incision (deep incisional) and/or any part of the anatomy (for example, organs and spaces) other than the incision that was opened or manipulated during an operation (organ/space). This will be documented in the medical record.
Timepoint [12] 379540 0
30 days postoperatively
Secondary outcome [13] 379541 0
Incidence of Urinary Retention - urinary retention being defined as the inability to pass retained urine (>300ml) requiring urinary catheterisation. Requirement for urinary catheterisation will be determined from the medical record.
Timepoint [13] 379541 0
72 hours postoperatively
Secondary outcome [14] 379542 0
Incidence of systolic blood pressure >180mmHg as measured using an automated or manual sphygmomanometer and recorded in the electronic medical record.
Timepoint [14] 379542 0
72 hours postoperatively
Secondary outcome [15] 379543 0
Incidence of bradycardia HR<40 beats per minute as measured by automated or manual assessment of pulse rate
Timepoint [15] 379543 0
72 hours postoperatively
Secondary outcome [16] 379545 0
>90% of recruited patients received drug as scheduled/protocol adherence
Timepoint [16] 379545 0
entire study period
Secondary outcome [17] 379546 0
>95% of recruited patients followed up
Timepoint [17] 379546 0
entire study period
Secondary outcome [18] 379547 0
>60% of approached patients recruited (minimum 3 patients recruited per week)
Timepoint [18] 379547 0
entire study period
Secondary outcome [19] 379548 0
Incidence of drug related adverse events as assessed by data-linkage to medical records
Timepoint [19] 379548 0
entire study period
Secondary outcome [20] 380357 0
Lowest measured systolic blood pressure as measured using an automated or manual sphygmomanometer and recorded in the electronic medical record.
Timepoint [20] 380357 0
0-48HRS postoperatively
Secondary outcome [21] 380358 0
Lowest mean arterial pressure as measured using an automated or manual sphygmomanometer and recorded in the electronic medical record.
Timepoint [21] 380358 0
0-48HRS postoperatively

Eligibility
Key inclusion criteria
Age >/= 70 years
ASA 3 or 4
Major body cavity surgery, joint arthroplasty, major vascular surgery or spinal surgery
Expected surgery duration > 2 hours
Planned hospital stay >/= 1 night
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Emergency or inpatient surgery
Pregnancy
Age < 70 years
Cardiac or intracranial neurosurgery
Planned critical care admission
Preoperative SBP >160mmHg
Known chronic urinary retention
Known hypersensitivity to midodrine
Other contraindication to midodrine

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical analysis will be performed by a biostatistician affiliated with the University of Melbourne. Numerical data will be analysed using Student’s T-test or Wilcoxon rank-sum test depending on normality. The Fisher's exact test will be used for categorical data. Feasibility outcomes will be reported using descriptive statistics. DAOH-30, one of the exploratory secondary outcome measures, is a relatively novel measure and will be analysed using a Cox proportional hazards model.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2020
Actual
Date of last participant enrolment
Anticipated
31/08/2020
Actual
Date of last data collection
Anticipated
30/09/2020
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15772 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 29205 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 304858 0
Hospital
Name [1] 304858 0
Austin Hospital
Country [1] 304858 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Department of Anaesthesia, Pain and Perioperative Medicine
145 Studley Road
Level 2, Austin Tower
Heidelberg, VIC 3084
Australia
Country
Australia
Secondary sponsor category [1] 305197 0
None
Name [1] 305197 0
N/A
Address [1] 305197 0
N/A
Country [1] 305197 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 305268 0
Austin Health HREC
Ethics committee address [1] 305268 0
Ethics committee country [1] 305268 0
Australia
Date submitted for ethics approval [1] 305268 0
26/02/2020
Approval date [1] 305268 0
Ethics approval number [1] 305268 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99826 0
Dr Justin Nazareth
Address 99826 0
Austin Hospital, Department of Anaesthesia, Pain and Perioperative Medicine
145 Studley Road
Level 2 Austin Tower
Heidelberg VIC 3084
Country 99826 0
Australia
Phone 99826 0
+61 394963800
Fax 99826 0
Email 99826 0
[email protected]
Contact person for public queries
Name 99827 0
Justin Nazareth
Address 99827 0
Austin Hospital, Department of Anaesthesia, Pain and Perioperative Medicine
145 Studley Road
Level 2 Austin Tower
Heidelberg VIC 3084
Country 99827 0
Australia
Phone 99827 0
+61 394963800
Fax 99827 0
Email 99827 0
[email protected]
Contact person for scientific queries
Name 99828 0
Justin Nazareth
Address 99828 0
Austin Hospital, Department of Anaesthesia, Pain and Perioperative Medicine
145 Studley Road
Level 2 Austin Tower
Heidelberg VIC 3084
Country 99828 0
Australia
Phone 99828 0
+61 394963800
Fax 99828 0
Email 99828 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
from the start of data collection for the study and for 7 years following
Available to whom?
Only to researchers who provide a methodologically sound proposal
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator (available via email [email protected])


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.