Clinical trial NCT04301102: The Predict H Trial
Official title: Intraoperative Hemodynamic Optimization Using the Hypotension Prediction Index and Its Impact of Tissular Perfusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraoperative Hypotension
Keywords: goal directed hemodynamic therapy
machine learning
acute kidney injury
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
First posted: 2020-03-10
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: TWA-MAP< 65 mmHg
timeFrame: Intraoperatively
measure: Number of intraoperative hypotension episodes
timeFrame: Intraoperatively
measure: Total time of hypotension per case
timeFrame: Intraoperatively
Secondary outcomes:
measure: StO2
timeFrame: Intraoperatively
measure: Acute kidney stress biomarkers
timeFrame: NC1: after anestesic induction // NC2: First 4 hours after the patient is admitted to the UCI/REA // NC3: 12 hours after NC2.
measure: Postoperative complications
timeFrame: Postoperatively
measure: Length of hospital stay
timeFrame: At 30 days
measure: Mortality
timeFrame: At 30 days
measure: Total fluid therapy during surgery
timeFrame: Intraoperatively
measure: Accumulated dose of Fentanyl, remifentanyl and/or morphine.
timeFrame: Intraoperatively
measure: Accumulated dose during the intraoperative period of vasoactive
timeFrame: Intraoperatively
measure: Accumulated dose during the intraoperative period of ionotopic drug
timeFrame: Intraoperatively
measure: Need and accumulated dose of drugs not included in previous groups
timeFrame: Intraoperatively
measure: Transfusion of total blood products during surgery
timeFrame: Intraoperatively
Other outcomes:
Locations:
city: Jerez De La Frontera
country: Spain
facility: Hospital Universitario de Jerez de la Frontera
state: Cádiz
city: Badajoz
country: Spain
facility: Hospital Universitario de Badajoz
city: Huelva
country: Spain
facility: Hospital Universitario Juan Ramón Jiménez
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
Study officials:
References:
citation: Lorente JV, Jimenez I, Ripolles-Melchor J, Becerra A, Wesselink W, Reguant F, Mojarro I, Fuentes MLA, Abad-Motos A, Agudelo E, Herrero-Machancoses F, Callejo P, Bosch J, Monge MI. Intraoperative haemodynamic optimisation using the Hypotension Prediction Index and its impact on tissular perfusion: a protocol for a randomised controlled trial. BMJ Open. 2022 Jun 2;12(6):e051728. doi: 10.1136/bmjopen-2021-051728.