The Predict H Trial
Intraoperative Hypotension
About this trial
This is an interventional prevention trial for Intraoperative Hypotension focused on measuring goal directed hemodynamic therapy, machine learning, acute kidney injury
Eligibility Criteria
Enrolled patients will be at least 65 years old and/or American Society of Anesthesiologist (ASA) physical status III/IV, scheduled for elective major abdominal surgery (general surgery, urology, or gynecology, through laparoscopic or open approach), with general or combined anesthesia. Surgery will be considered to be major if the expected duration is > 2 h, or the estimated blood loss is > 15% of blood volume, or if the expected required transfusion is ≥ 2 packed red blood cells.
Exclusion criteria will be pregnancy, surgery performed only under regional anesthesia, preoperative glomerular filtrate < 60 ml/min/1.73m2 according to the CKD-EPI 2009 formula, persistent atrial fibrillation, known cardiac shunts or if the patient received a kidney transplant, and refusal of the patient to participate in the study.
Sites / Locations
- Hospital Universitario de Jerez de la Frontera
- Hospital Universitario de Badajoz
- Hospital Universitario Juan Ramón Jiménez
- Hospital Universitario Infanta Leonor
- Hospital Universitario Virgen del Rocío
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Experimental
Control
Hemodynamic management will be based on the functional hemodynamic parameters provided by Hemosphere platform with the Acumen IQ sensor, including cardiac output, stroke volume, SVV and Acumen IQ specific parameters: maximal arterial pressure rise (dP/dtmax), dynamic arterial elastance (Eadyn) and HPI As a pattern replacement of interstitial space, we will use balanced crystalloid (Isofundin®) at 1-3 ml / kg / h in case of laparoscopic surgery and 5 to 7 ml / kg / h in case of open surgery. The protocol of action on the intravascular space will be based on the maintenance of systolic volume with colloids (hydroxyethyl starch - Voluvén®).
Hemodynamic management will be based on the functional hemodynamic parameters provided by the HemoSphere platform® with the FloTrac® sensor, including cardiac output (CO), stroke volume (SV), and stroke volume variation (SVV) As a pattern replacement of interstitial space, we use balanced crystalloid (Isofundin®) at 1-3 ml / kg / h in case of laparoscopic surgery and 5 to 7 ml / kg / h in case of open surgery. The protocol action for the intravascular space will be based on a recently published hemodynamic optimization algorithm (Heming N, Moine P, Coscas R, Annane D. Perioperative fluid management for major elective surgery. British Journal of Surgery. 2020;107:e56-62). The fluid used will be hydroxyethyl starch (Voluven®).