The Predict H Trial

Intraoperative Hypotension Clinical Trial

Official title:

Intraoperative Hemodynamic Optimization Using the Hypotension Prediction Index and Its Impact of Tissular Perfusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04301102
• Other study ID #: v 1.0; March 2019
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: December 2022
• Source: Andalusian Network for Design and Translation of Advanced Therapies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 1, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypotension
• Intraoperative Hypotension

Intervention

Device:
• 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 ...).
• 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 ...).

Locations

Country	Name	City	State
Spain	Hospital Universitario de Badajoz	Badajoz
Spain	Hospital Universitario Juan Ramón Jiménez	Huelva
Spain	Hospital Universitario de Jerez de la Frontera	Jerez De La Frontera	Cádiz
Spain	Hospital Universitario Infanta Leonor	Madrid
Spain	Hospital Universitario Virgen del Rocío	Sevilla

Sponsors (2)

Lead Sponsor	Collaborator
Juan Victor Lorente	Edwards Lifesciences

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Intraoperatively
Primary	Number of intraoperative hypotension episodes	defined as an event of MAP < 65 mmHg of at least 1-minute duration	Intraoperatively
Primary	Total time of hypotension per case	Intraoperative Total time of hypotension (MAP < 65 mmHg)	Intraoperatively
Secondary	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	Intraoperatively
Secondary	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.	NC1: after anestesic induction // NC2: First 4 hours after the patient is admitted to the UCI/REA // NC3: 12 hours after NC2.
Secondary	Postoperative complications	The analysis of postoperative complications will be carried out in accordance with European EPCO recommendations.	Postoperatively
Secondary	Length of hospital stay		At 30 days
Secondary	Mortality		At 30 days
Secondary	Total fluid therapy during surgery	Types and total amounts	Intraoperatively
Secondary	Accumulated dose of Fentanyl, remifentanyl and/or morphine.	Accumulated dose during the intraoperative period	Intraoperatively
Secondary	Accumulated dose during the intraoperative period of vasoactive	Specify by drugs used and method of infusion (bolus / continuous infusion pump)	Intraoperatively
Secondary	Accumulated dose during the intraoperative period of ionotopic drug	In case of indication.	Intraoperatively
Secondary	Need and accumulated dose of drugs not included in previous groups	Dexmedetomidine, esmolol or other drugs with hemodynamic impact	Intraoperatively
Secondary	Transfusion of total blood products during surgery		Intraoperatively