The Hypotension Prediction Index in Major Abdominal Surgery
ConditionHypotension During Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJakub Szrama
About this trial
The goal of this randomized clinical trial is to compare different types of advanced hemodynamic monitoring in patients undergoing major abdominal surgery.
Participants undergoing major abdominal surgery will receive anesthesia with two different types of hemodynamic monitoring - group A will receive arterial pressure cardiac output algorithm with the FloTrac sensor and group B will receive hemodynamic monitoring with the Hypotension Prediction Index.
The main question the study aims to answer is:
• will the hypotension prediction index algorithm reduce the rate of hypotension in comparison to arterial pressure cardiac output algorithm.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients qualified for elective major abdominal surgery, defined as an expected duration of more than two hours, an estimated blood loss of >15% of blood volume, or an expected transfusion requirement of at least two packed red blood cells with general or combined anaesthesia.
Patients with American Society of Anesthesiologists (ASA) status III or IV.
Written informed consent.
Disqualifiers
Patients under 18 years
Lack of health insurance
Pregnancy
Known history of congenital heart disease, severe aortic and/or mitral stenosis, heart failure and ejection fraction < 35 %
Trial design
Design model
Parallel
Treatments tested in this trial
Hypotension Prediction Index Hemodynamic Monitoring
DeviceThe application of the perioperative hemodynamic management according to the hypotension prediction index algorithm.
Treatment groups
226 Participants
are divided into 2 treatment groupsGroup A: Group A - FloTrac groupNo intervention 0 interventions
Group B: Group B - HPI - Hypotension Prediction Index groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Time weighed average of hypotension below 65 mmHg
depth of hypotension in millimetres of mercury below a mean arterial pressure (MAP) of 65 mmHg x time in minutes spent below MAP of 65mmHg)/total duration of operation in minutes
Time frame
"From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 daysSecondary outcomes
1
Time weighed average of hypotension below 50 mmHg
depth of hypotension in millimetres of mercury below a MAP of 50 mmHg x time in minutes spent below MAP of 50 mmHg)/total duration of operation in minutes
Time frame
"From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days2
Time weighed average of hypertension above 90 mmHg
rise of hypertension in millimetres of mercury above a MAP of 90 mmHg x time in minutes spent above MAP of 90 mmHg)/total duration of operation in minutes
Time frame
"From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days3
Time weighed average of hypertension above 100 mmHg
rise of hypertension in millimetres of mercury above MAP of 100 mmHg x time in minutes spent above MAP of 100 mmHg)/total duration of operation in minutes
Time frame
"From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days4
30 day mortality
30 day mortality
Time frame
30 consecutive days starting from the day of the surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Jakub Szrama
Lead sponsor
Poznan University of Medical Sciences
Sponsor institution
Source ClinicalTrials.gov