Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04301102
Study type Interventional
Source Andalusian Network for Design and Translation of Advanced Therapies
Contact
Status Completed
Phase N/A
Start date November 1, 2020
Completion date June 1, 2022

See also
  Status Clinical Trial Phase
Completed NCT04519203 - The Use of Surgical Pleth Index in Guiding Anesthesia in Gastroenterological Surgery N/A
Recruiting NCT05011357 - Phenylephrine and Pulse Pressure Variability Early Phase 1
Completed NCT04025086 - Perioperative Goal Directed Therapy (PGDT) in Spinal Surgery in the Prone Position
Completed NCT03965793 - Individualized Fluid And Vasopressor Administration In Surgical Patients N/A
Completed NCT05101590 - Hypotension Decision Assist - Use, Safety and Efficacy N/A
Recruiting NCT05557253 - Effects of Remimazolam on the Intraoperative Hemodynamics in Bypass Surgery N/A
Completed NCT04547491 - Hypotension Prediction With HPI Algorithm During Major Gynecologic Oncologic Surgery N/A
Completed NCT03376347 - Intraoperative Implementation of the Hypotension Probability Indicator N/A
Recruiting NCT06091904 - Effects of Sufentanil on the Intraoperative Hemodynamics N/A
Recruiting NCT04120012 - The Effect of Frailty to Perioperative Complications in the Elderly
Recruiting NCT06202638 - Hypotension Prediction Index (HPI) in Lung Resections
Completed NCT05671783 - Intraoperative Hypotension and Post-anesthesia Care Unit Recovery
Completed NCT05821647 - Hypotension Prediction 2 Study in Cardiac Surgery and Postoperative ICU Admission N/A
Recruiting NCT04872504 - Hypotension Prediction Index in Patients Undergoing Liver Transplantation N/A
Completed NCT03974321 - Intraoperative Hypotension and Perioperative Myocardial Injury
Recruiting NCT05637606 - HIgh Versus STAndard Blood Pressure Target in Hypertensive High-risk Patients Undergoing Major Abdominal Surgery N/A
Completed NCT03889730 - Intraoperative Hypotension and Acute Kidney Injury After Off-pump Coronary Artery Bypass Grafting Surgery
Completed NCT03442907 - Personalized Blood Pressure Management N/A
Recruiting NCT03795831 - Validation Study in Patients of a Non-invasive Blood Pressure Monitor for Perioperative Use
Recruiting NCT05341167 - HPI Algorithm for the Prevention of IOH During Spinal Surgery [HPIFPIOH] N/A