The goal of this clinical trial is to investigate if the use of the hypotension prediction index during the perioperative period leads to a decrease in hypotension both during and after surgery (24 hrs) in adults undergoing major abdominal surgery. The main question this trial aims to answer is: • Does the use of the hypertension prediction index (HPI) decrease hypotension during surgery and in the post-operative period? During and after their surgery, participants in the intervention group will be treated according to the HPI-algorithm. Participants in the control group will be treated following the standard of care.
Rationale: Hypotension during and after surgery is associated with serious complications. Using a machine learning algorithm, hypotension can be accurately predicted. Edwards Lifesciences developed this algorithm, called "Hypotension Prediction Index" and integrated this in their hemodynamical monitors. Recent studies have shown a decrease in intraoperative hypotension when using the hypotension prediction index. Objective: To investigate if the use of the hypotension prediction index during the perioperative period leads to a decrease in hypotension (time weighted average) both during and after surgery (24 hrs). Intervention: Patients in the intervention group will be treated using the hypotension prediction index algorithm to prevent hypotension. In case of actual hypotension the treatment thereof is at the discretion of the anaesthesiologist. Main study parameters/endpoints: The decrease in time weighted average of hypotension in the peri- and post-operative period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
50
Treatment of hypotension guided by the hypotension prediction index. Patients will receive treatment following the predetermined HPI-algorithm when the HPI exceeds 85%.
Patients receive standard of care treatment for hypotension, with a goal-mean arterial pressure (MAP) of 65mmHg.
Time Weighted Average of hypotension
Time Weighted Average (TWA) is measured as (depth of hypotension in mmHg below a MAP op 65mmHg x time in minutes spent below a MAP of 65mmHg) ÷ total duration of surgery/PACU admission in minutes)
Time frame: During the accumulative duration of surgery and PACU admission
Frequency and duration of hypotension
Defined as MAP\<65mmHg for at least 1 minute
Time frame: During surgery and in the 24 hours following surgery
Frequency and duration of hypertension
Defined as MAP\>100mmHg for at least 1 minute
Time frame: During surgery and in the 24 hours following surgery
Total amount of administered fluids
Total amount of administered fluids (absolute, ml/kg/min, input/output ratio)
Time frame: During surgery and in the 24 hours following surgery
Total administration of vasopressors
Total administration of vasopressors (mcg/kg/min)
Time frame: During surgery and in the 24 hours following surgery
Total administration of inotropy
Total administration of inotropy (mcg/kg/min)
Time frame: During surgery and in the 24 hours following surgery
Eligibility for discharge to the ward on the day after surgery
Eligibility defined as yes or no
Time frame: During morning rounds the day after surgery (approximately at 10.00hours)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Lactate
Lactate level as measured in arterial blood gas
Time frame: "at the start of surgery", "at PACU admission", "day after surgery at 06.00hours"
Glomerular filtration rate
Glomerular filtration rate as measured in arterial blood gas
Time frame: "at the start of surgery", "at PACU admission", "day after surgery at 06.00hours"
Number and type of complications in the first 30 days after surgery
Number and type of complications in the first 30 days after surgery
Time frame: 30 days after surgery