The Hypotension Prediction Index in Major Abdominal Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hypotension Prediction Index Hemodynamic Monitoring.
- Who it may be relevant to
- Registry conditions: Hypotension During Surgery. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Hypotension Prediction Index in Major Abdominal Surgery - a Prospective Randomized Clinical Trial.
Overview
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.
Detailed description
The fundamental aspect of the anesthetics perioperative management is to maintain hemodynamic stability, with special attention on the avoidance or reduction of the episodes of intraoperative hypotension (IOH). The incidence of intraoperative hypotension is related to an increased rate of perioperative morbidity and mortality. Even a short period of hypotension can be related to an increased risk of postoperative stroke, myocardial injury and acute kidney injury. Patients undergoing major abdominal surgery are at a high-risk of IOH because such surgeries typically require more than 2h to complete and require blood transfusion or inotrope administration. Hemodynamic monitoring and the use of goal directed therapy protocols helps to diminish the incidence of perioperative complications, however the hypotension management remains a reactive approach, an intervention is made when the hypotension has already occured. The Hypotension Prediction Index is an machine learning algorithm which allows to predict the episodes of hypotension and intervene before mean arterial pressure drops below 65 mmHg. The aim of the current study is to compare the rate of hypotension in patients undergoing major abdominal surgery with the arterial pressure cardiac output algorithm and the hypotension prediction index algorithm.
Interventions
- Device Hypotension Prediction Index Hemodynamic Monitoring
The application of the perioperative hemodynamic management according to the hypotension prediction index algorithm.
Primary outcome measures
- Time weighed average of hypotension below 65 mmHg [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 days]
Secondary outcome measures (10)
- Time weighed average of hypotension below 50 mmHg [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 days]
- Time weighed average of hypertension above 90 mmHg [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 days]
- Time weighed average of hypertension above 100 mmHg [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 days]
- 30 day mortality [Time frame: 30 consecutive days starting from the day of the surgery]
- Length of hospitalisation [Time frame: From the date of randomisation to the date of hospital discharge or death, whichever comes first, assessed up to 30 days]
- Myocardial injury evaluated by postoperative troponin levels [Time frame: First, second and fifth postoperative day]
- Kidney injury evaluated by creatinine levels [Time frame: First, second and fifth postoperative day]
- Intraoperative fluid dose [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 days]
- Intraoperative vasopressor dose [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 days]
- Rate of intra and postoperative atrial fibrillation [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 days]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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 %
- Persistent atrial fibrillation and other arrhythmias impairing arterial pressure cardiac output monitoring
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Poland · 1 center
- Department of Anesthesiology, Intensive Therapy and Pain Management — Poznan
Publications
- Szrama J, Gradys A, Nowak Z, Lohani A, Zwolinski K, Bartkowiak T, Wozniak A, Koszel T, Kusza K. The hypotension prediction index in major abdominal surgery - A prospective randomised clinical trial protocol. Contemp Clin Trials Commun. 2024 Dec 28;43:101417. doi: 10.1016/j.conctc.2024.101417. eCollection 2025 Feb. PMID 39895857
Identifiers
NCT: NCT06247384 · PoznanUMSHPI