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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]

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

Condition category

Condition code

Anaesthesiology

Other anaesthesiology

Cardiovascular

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]

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]

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]

0-48HRS postoperatively

Primary outcome [2]

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]

0-48HRS postoperatively

Secondary outcome [1]

Incidence of MAP <65mmHg as measured using an automated or manual sphygmomanometer and recorded in the electronic medical record.

Timepoint [1]

0-48HRS postoperatively

Secondary outcome [2]

30-day mortality - collected using data-linkage to medical records

Timepoint [2]

30 days postoperatively

Secondary outcome [3]

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]

30 days postoperatively

Secondary outcome [4]

Total hospital length of stay - This information will be collected via data-linkages with electronic medical records.

Timepoint [4]

30 days postoperatively

Secondary outcome [5]

Readmission at 30 days - This information will be collected via data-linkages with electronic medical records.

Timepoint [5]

30 days postoperatively

Secondary outcome [6]

Unplanned critical care admission - This information will be collected via data-linkages with electronic medical records.

Timepoint [6]

30 days postoperatively

Secondary outcome [7]

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]

48 hours postoperatively

Secondary outcome [8]

Perioperative fluid balance measured in millilitres - This information will be collected via data-linkages with electronic medical records.

Timepoint [8]

48 hours postoperatively

Secondary outcome [9]

Myocardial Injury after Non-cardiac Surgery (MINS) as defined by an elevated serum high-sensitivity troponin T to >20ng/L

Timepoint [9]

72 hours postoperatively

Secondary outcome [10]

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]

30 days postoperatively

Secondary outcome [11]

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]

30 days postoperatively

Secondary outcome [12]

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]

30 days postoperatively

Secondary outcome [13]

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]

72 hours postoperatively

Secondary outcome [14]

Incidence of systolic blood pressure >180mmHg as measured using an automated or manual sphygmomanometer and recorded in the electronic medical record.

Timepoint [14]

72 hours postoperatively

Secondary outcome [15]

Incidence of bradycardia HR<40 beats per minute as measured by automated or manual assessment of pulse rate

Timepoint [15]

72 hours postoperatively

Secondary outcome [16]

>90% of recruited patients received drug as scheduled/protocol adherence

Timepoint [16]

entire study period

Secondary outcome [17]

>95% of recruited patients followed up

Timepoint [17]

entire study period

Secondary outcome [18]

>60% of approached patients recruited (minimum 3 patients recruited per week)

Timepoint [18]

entire study period

Secondary outcome [19]

Incidence of drug related adverse events as assessed by data-linkage to medical records

Timepoint [19]

entire study period

Secondary outcome [20]

Lowest measured systolic blood pressure as measured using an automated or manual sphygmomanometer and recorded in the electronic medical record.

Timepoint [20]

0-48HRS postoperatively

Secondary outcome [21]

Lowest mean arterial pressure as measured using an automated or manual sphygmomanometer and recorded in the electronic medical record.

Timepoint [21]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Austin Hospital

Country [1]

Australia

Primary sponsor type

Hospital

Name

Austin Health

Country

Australia

Secondary sponsor category [1]

None

Name [1]

N/A

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Austin Health HREC

Ethics committee address [1]

Austin Health HREC
145 Studley Road
Heidelberg, VIC 3084
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/02/2020

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Anaesthesia and surgery commonly contribute to low blood pressure during and after an operation through a variety of mechanisms. Adequate blood pressure is essential to allow for blood flow and oxygen delivery to organs throughout the body such as the heart, brain and kidneys. There is an accumulating body of evidence that low blood pressure after surgery is very common and is likely underrecognised. These episodes of low blood pressure have been linked to increased rates of organ injury, complications and death following surgery.  

Midodrine is a drug used to help increase blood pressure. The METEORITE trial has been designed to determine if the use of midodrine before and after surgery is able to reduce the occurrence of low blood pressure in the time following an operation. In this trial, one group of patients will receive midodrine before and for two days after surgery and another comparison group will receive standard care (no midodrine).  Both groups will then be followed during and after their surgery to determine if there is a difference between the two groups with respect to important outcomes such as the number of times low blood pressure occurs and the requirement for medical emergency team review. Data on complications following surgery will also be collected. Finally, as this is a pilot study, a number of specific outcomes to assess the feasibility of performing a larger multi-centre study will also be collected and reported.

If the study hypothesis is correct, patients who receive midodrine before and after their scheduled surgery will have fewer episodes of clinically significant low blood pressure following their operation and will be less likely to require unplanned medical emergency team review. This may result in improved outcomes after surgery.

Trial website

Public notes

Contacts

Principal investigator

Name

Dr Justin Nazareth

Address

Austin Hospital, Department of Anaesthesia, Pain and Perioperative Medicine 145 Studley Road Level 2 Austin Tower Heidelberg VIC 3084

Country

Australia

Phone

+61 394963800

Fax

justin.nazareth@austin.org.au

Contact person for public queries

Name

Justin Nazareth

Address

Austin Hospital, Department of Anaesthesia, Pain and Perioperative Medicine 145 Studley Road Level 2 Austin Tower Heidelberg VIC 3084

Country

Australia

Phone

+61 394963800

Fax

justin.nazareth@austin.org.au

Contact person for scientific queries

Name

Justin Nazareth

Address

Austin Hospital, Department of Anaesthesia, Pain and Perioperative Medicine 145 Studley Road Level 2 Austin Tower Heidelberg VIC 3084

Country

Australia

Phone

+61 394963800

Fax

justin.nazareth@austin.org.au

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Only to researchers who provide a methodologically sound proposal

Conditions for requesting access:
• -

What individual participant data might be shared?

• All of the individual participant data collected during the trial, after de-identification

What types of analyses could be done with individual participant data?

• Any purpose

When can requests for individual participant data be made (start and end dates)?

From:
from the start of data collection for the study and for 7 years following

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Access subject to approvals by Principal Investigator (available via email justin.nazareth@austin.org.au)

Are there extra considerations when requesting access to individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically