The Predict H Trial

Juan Victor Lorente80 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Intraoperative Hypotension

Interventions

Hemosphere platform® together with the FloTrac Acumen IQ® sensorDEVICE

Clinical platform that, analyzing the pulse wave contour, obtained from the previously catheterized radial artery, is able to make available to the clinician both a continuous monitoring of blood pressure and advanced hemodynamic parameters that help patient management. It incorporates predictive parameters such as the hypotension prediction index and decision support parameters such as dynamic arterial elastance and maximum dP / dT. It also has the possibility of assessing regional oxygen saturation, measured by near-infrared light photoplethysmography, and the sensor can be applied in different locations (cerebral, muscular ...).

Hemosphere platform® together with the FloTrac® sensorDEVICE

Clinical platform that, analyzing the pulse wave contour, obtained from the previously catheterized radial artery, is able to make available to the clinician both a continuous monitoring of blood pressure and advanced hemodynamic parameters that help patient management. It also has the possibility of assessing regional oxygen saturation, measured by near-infrared light photoplethysmography, and the sensor can be applied in different locations (cerebral, muscular ...).

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Locations (5)

Hospital Universitario de Jerez de la Frontera

Jerez de la Frontera, Cádiz, Spain

Hospital Universitario de Badajoz

Badajoz, Spain

Hospital Universitario Juan Ramón Jiménez

Huelva, Spain

Hospital Universitario Infanta Leonor

Madrid, Spain

Outcomes

Primary Outcomes

TWA-MAP< 65 mmHg

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).

Time frame: Intraoperatively

Number of intraoperative hypotension episodes

defined as an event of MAP \< 65 mmHg of at least 1-minute duration

Time frame: Intraoperatively

Total time of hypotension per case

Intraoperative Total time of hypotension (MAP \< 65 mmHg)

Time frame: Intraoperatively

Secondary Outcomes

StO2

StO2 will be non-invasively and continuously recorded in the brachioradial muscle in the arm opposite to the arterial line. We calculated the time averaged StO2 per patient and identified the minimum StO2, defined as the minimum value sustained (+1%) over at least 5 min

Time frame: Intraoperatively

Acute kidney stress biomarkers

Urine immunoassay, commercially known as Nephrocheck® (Biomerieux). The first sample (NC1) will be collected after anesthetic induction, when performing bladder catheterization. The first postoperative sample (NC2) will be collected during the first 4 hours after the patient is admitted to the UCI / REA for their postoperative stay. If the AKIRisk value in that first postoperative sample (NC2) is less than 0.3, no new Nephrocheck® determinations will be collected. If the AKIRisk value in the first postoperative sample (NC2) is greater than 2, no further Nephrocheck® determinations will be made. If the AKIRisk value in that first postoperative sample (NC2) is between 0.3 and 2, we will collect a second postoperative sample (NC3) at 12 hours of the first. No more Nephrocheck® determinations will be made.

Time frame: NC1: after anestesic induction // NC2: First 4 hours after the patient is admitted to the UCI/REA // NC3: 12 hours after NC2.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.