Intraoperative Hemodynamic Optimization Using the Hypotension Prediction Index and Its Impact of Tissular Perfusion
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Intraoperative Hypotension
- Sponsor
- Juan Victor Lorente
- Enrollment
- 80
- Locations
- 5
- Primary Endpoint
- TWA-MAP< 65 mmHg
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The aim of the study is to determine whether a goal-directed algorithm based on the prevention of arterial hypotension using the Hypotension Prediction Index reduces the duration and severity of intraoperative hypotension when compared with the recommended standard therapy and if this intraoperative strategy affects tissue oxygenation and organ perfusion.
Detailed Description
Background: Intraoperative arterial hypotension is associated with poor postoperative outcomes. The Hypotension Prediction Index developed from machine learning, predicts the occurrence of arterial hypotension from the analysis of the arterial pressure waveform. The use of this index can reduce the duration and severity of intraoperative hypotension in adults undergoing noncardiac surgery. Methods: We will conduct a multicenter, randomized, controlled trial (N=80) in high-risk surgical patients scheduled for elective major abdominal surgery. All participants will be randomly assigned to a control or intervention group. Hemodynamic management in the control group will be based on standard hemodynamic parameters. Hemodynamic management of patients in the intervention group will be based on functional hemodynamic parameters provided by Hemosphere platform (Edwards Lifesciences Ltd), including dynamic arterial elastance, dP/dtmax and the Hypotension Prediction Index. Tissue oxygen saturation will be non-invasively and continuously recorded by using near-infrared spectroscopy technology. Biomarkers of acute kidney stress (cTIMP2 and IGFBP7) will be obtained before and after surgery. The primary outcome will be intraoperative time-weighted average with a mean arterial pressure \< 65mmHg. Discussion: The aim of the study is to determine whether a goal-directed algorithm based on the prevention of arterial hypotension using the Hypotension Prediction Index reduces the duration and severity of intraoperative hypotension when compared with the recommended standard therapy and if this intraoperative strategy affects tissue oxygenation and organ perfusion.
Investigators
Juan Victor Lorente
Anesthesiologist
Andalusian Network for Design and Translation of Advanced Therapies
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
TWA-MAP< 65 mmHg
Time Frame: Intraoperatively
Area between 65 mmHg threshold and the curve of the MAP measurements divided by the total continuous reading time mmHg for a minimum duration of 1 minute (3 consecutive records from one minute to more between two consecutive falls).
Number of intraoperative hypotension episodes
Time Frame: Intraoperatively
defined as an event of MAP \< 65 mmHg of at least 1-minute duration
Total time of hypotension per case
Time Frame: Intraoperatively
Intraoperative Total time of hypotension (MAP \< 65 mmHg)
Secondary Outcomes
- StO2(Intraoperatively)
- Postoperative complications(Postoperatively)
- Total fluid therapy during surgery(Intraoperatively)
- Acute kidney stress biomarkers(NC1: after anestesic induction // NC2: First 4 hours after the patient is admitted to the UCI/REA // NC3: 12 hours after NC2.)
- Accumulated dose during the intraoperative period of vasoactive(Intraoperatively)
- Need and accumulated dose of drugs not included in previous groups(Intraoperatively)
- Transfusion of total blood products during surgery(Intraoperatively)
- Length of hospital stay(At 30 days)
- Mortality(At 30 days)
- Accumulated dose of Fentanyl, remifentanyl and/or morphine.(Intraoperatively)
- Accumulated dose during the intraoperative period of ionotopic drug(Intraoperatively)