The Predict H Trial

NCT ID: NCT04301102

Last Updated: 2022-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2022-06-01

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.

Conditions

Intraoperative Hypotension

Keywords

goal directed hemodynamic therapy; machine learning; acute kidney injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Experimental

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®).

Group Type: EXPERIMENTAL

Hemosphere platform® together with the FloTrac Acumen IQ® sensor

Intervention Type: DEVICE

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 ...).

Control

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®).

Group Type: OTHER

Hemosphere platform® together with the FloTrac® sensor

Intervention Type: DEVICE

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 ...).

Interventions

Hemosphere platform® together with the FloTrac Acumen IQ® sensor

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 ...).

Intervention Type: DEVICE

Hemosphere platform® together with the FloTrac® sensor

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 ...).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion 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

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: collaborator

Juan Victor Lorente

OTHER

Sponsor Role: lead

Responsible Party

Juan Victor Lorente

Anesthesiologist

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

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

Hospital Universitario Virgen del Rocío

Seville, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 35654467 (View on PubMed)

Other Identifiers

v 1.0; March 2019

Identifier Type: -

Identifier Source: org_study_id