Post Anaesthesia Care Hypotension Prevention

Not Applicable

Not yet recruiting

• Conditions: Hypotension During Surgery

• Registration Number: NCT05844774
• Lead Sponsor: Radboud University Medical Center

Brief Summary

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.

Detailed Description

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 Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-30
• Study First Submitted QC: 2023-04-25
• Last Update Submitted: 2023-04-25
• Study First Posted: 2023-05-06
• Last Update Posted: 2023-05-06
• Study Start: 2023-05-22
• Primary Completion: 2024-06-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients > 18 years old
• Patients planned to undergo laparotomy surgery
• Patients that will receive an invasive arterial catheter as part of their procedure
• Patients that are planned to go to the post anaesthetic care unit (PACU) post-operatively

Exclusion Criteria

• Patients with known arrythmias
• Patients with known severe heart valve disease
• Patients with the need for dialysis
• Clamping of the aorta or Pringle's manoeuvre during surgery
• Emergency procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time Weighted Average of hypotension	During the accumulative duration of surgery and PACU admission	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)

Secondary Outcome Measures

Name	Time	Method
Lactate	"at the start of surgery", "at PACU admission", "day after surgery at 06.00hours"	Lactate level as measured in arterial blood gas
Total amount of administered fluids	During surgery and in the 24 hours following surgery	Total amount of administered fluids (absolute, ml/kg/min, input/output ratio)
Eligibility for discharge to the ward on the day after surgery	During morning rounds the day after surgery (approximately at 10.00hours)	Eligibility defined as yes or no
Frequency and duration of hypotension	During surgery and in the 24 hours following surgery	Defined as MAP\<65mmHg for at least 1 minute
Number and type of complications in the first 30 days after surgery	30 days after surgery	Number and type of complications in the first 30 days after surgery
Glomerular filtration rate	"at the start of surgery", "at PACU admission", "day after surgery at 06.00hours"	Glomerular filtration rate as measured in arterial blood gas
Frequency and duration of hypertension	During surgery and in the 24 hours following surgery	Defined as MAP\>100mmHg for at least 1 minute
Total administration of vasopressors	During surgery and in the 24 hours following surgery	Total administration of vasopressors (mcg/kg/min)
Total administration of inotropy	During surgery and in the 24 hours following surgery	Total administration of inotropy (mcg/kg/min)