None listed
Conditions
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.
Interventions
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. Admin
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.
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed