Post Anaesthesia Care Hypotension Prevention

Hypotension During Surgery Clinical Trial

— PACH-1  

Official title:

The Clinical Effects of Perioperative Use of the Hypotension Prediction Index

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05844774
• Other study ID #: NL81361.091
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 22, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: March 2023
• Source: Radboud University Medical Center
• Contact: Van Eijk
• Phone: 0624501517
• Email: lucas.vaneijk[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Hypotension During Surgery

Intervention

Device:
• HPI (using HemoSphere) - guided algorithm
Treatment of hypotension guided by the hypotension prediction index. Patients will receive treatment following the predetermined HPI-algorithm when the HPI exceeds 85%.
• Treatment of hypotension following standard of care
Patients receive standard of care treatment for hypotension, with a goal-mean arterial pressure (MAP) of 65mmHg.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	Edwards Lifesciences

Outcome

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