Hypotension During SurgeryPACH-1NCT05844774
Post Anaesthesia Care Hypotension Prevention
A study testing HPI (using HemoSphere) - guided algorithm in people with Hypotension During Surgery, run by Radboud University Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension During Surgery
- What is being tested?
- HPI (using HemoSphere) - guided algorithm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 22 May 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Clinical Effects of Perioperative Use of the Hypotension Prediction Index
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.
Read the 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.
- Conditions
- Hypotension During Surgery
- Being tested
- HPI (using HemoSphere) - guided algorithm, Treatment of hypotension following standard of care
- Keywords
- Laparotomy, Hypotension, Goal Directed Therapy, Post-operative, Prediction, Artificial intelligence
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPI (using HemoSphere) - guided algorithmDevice
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 careDevice
Patients receive standard of care treatment for hypotension, with a goal-mean arterial pressure (MAP) of 65mmHg.
| Study group | Role | What they receive |
|---|---|---|
| HPI-intervention algorithm | Experimental | In the intervention group the HemoSphere screen is visible and the anesthesiologist and PACU personal are instructed to follow the algorithm (chapter 4) in case of a HPI >85%. The purpose of the alarm at 85% and the presented algorithm is to prevent hypotension. If hypotension occurs, it should be treated as according to the standard of care. Receives: Device: HPI (using HemoSphere) - guided algorithm |
| Control group | Other | Patients in the control group are connected to the HemoSphere monitor to evaluate the TWA of hypotension in this group. The screen is not visible to the anesthesiologist or PACU personal and the alarm is set silent. It will be explained to the anesthesiologist and PACU personal that the patients are included to this study and that a blood pressure with a MAP of 65 mmHg should be monitored. Receives: Device: Treatment of hypotension following standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: During the accumulative duration of surgery and PACU admission
Secondary outcomes (9)
Frequency and duration of hypotension
Defined as MAP<65mmHg for at least 1 minute
Measured: During surgery and in the 24 hours following surgery
Frequency and duration of hypertension
Defined as MAP>100mmHg for at least 1 minute
Measured: 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)
Measured: During surgery and in the 24 hours following surgery
Total administration of vasopressors
Total administration of vasopressors (mcg/kg/min)
Measured: During surgery and in the 24 hours following surgery
Total administration of inotropy
Total administration of inotropy (mcg/kg/min)
Measured: 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
Measured: During morning rounds the day after surgery (approximately at 10.00hours)
Lactate
Lactate level as measured in arterial blood gas
Measured: "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
Measured: "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
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start22 May 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension During SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1 control group, 1 intervention group without cross-over
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Sponsor
- Investigators
- Van Eijk, Principal investigator, Coordinating Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844774
- Sponsor's protocol ID
- NL81361.091
- Acronym
- PACH-1
- Status last verified
- Mar 2023
- First submitted
- 30 Mar 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effects of Perioperative Use of the Hypotension Prediction Index
- ClinicalTrials.gov ID
- NCT05844774
- Acronym / sponsor ID
- PACH-1 / NL81361.091
- Conditions
- Hypotension During Surgery
- Keywords
- Laparotomy, Hypotension, Goal Directed Therapy, Post-operative, Prediction, Artificial intelligence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- 22 May 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1 control group, 1 intervention group without cross-over
| Arm | Type | Receives |
|---|---|---|
| HPI-intervention algorithm | Experimental | Device: HPI (using HemoSphere) - guided algorithmIn the intervention group the HemoSphere screen is visible and the anesthesiologist and PACU personal are instructed to follow the algorithm (chapter 4) in case of a HPI >85%. The purpose of the alarm at 85% and the presented algorithm is to prevent hypotension. If hypotension occurs, it should be treated as according to the standard of care. |
| Control group | Other | Device: Treatment of hypotension following standard of carePatients in the control group are connected to the HemoSphere monitor to evaluate the TWA of hypotension in this group. The screen is not visible to the anesthesiologist or PACU personal and the alarm is set silent. It will be explained to the anesthesiologist and PACU personal that the patients are included to this study and that a blood pressure with a MAP of 65 mmHg should be monitored. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPI (using HemoSphere) - guided algorithmTreatment of hypotension guided by the hypotension prediction index. Patients will receive treatment following the predetermined HPI-algorithm when the HPI exceeds 85%. | Device | HPI-intervention algorithm |
| Treatment of hypotension following standard of carePatients receive standard of care treatment for hypotension, with a goal-mean arterial pressure (MAP) of 65mmHg. | Device | Control group |
Primary outcome
Time Weighted Average of hypotension
Time frame: 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)
9 secondary outcomes
Frequency and duration of hypotension
Time frame: During surgery and in the 24 hours following surgery
Frequency and duration of hypertension
Time frame: During surgery and in the 24 hours following surgery
Total amount of administered fluids
Time frame: During surgery and in the 24 hours following surgery
Total administration of vasopressors
Time frame: During surgery and in the 24 hours following surgery
Total administration of inotropy
Time frame: During surgery and in the 24 hours following surgery
Eligibility for discharge to the ward on the day after surgery
Time frame: During morning rounds the day after surgery (approximately at 10.00hours)
Lactate
Time frame: "at the start of surgery", "at PACU admission", "day after surgery at 06.00hours"
Glomerular filtration rate
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
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Van Eijk principal investigator
Coordinating Investigator
Questions about this trial
What is this clinical trial studying?
A study testing HPI (using HemoSphere) - guided algorithm in people with Hypotension During Surgery, run by Radboud University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Van Eijk (0624501517, lucas.vaneijk@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Weighted Average of hypotension (time frame: During the accumulative duration of surgery and PACU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.