The Predict H Trial

Not Applicable

Completed

• Conditions: Intraoperative Hypotension

• Registration Number: NCT04301102
• Lead Sponsor: Juan Victor Lorente

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.

Study Timeline

• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-03-05
• Study First Posted: 2020-03-10
• Study Start: 2020-11-01
• Primary Completion: 2022-02-28
• Study Completion: 2022-06-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-07
• Last Update Posted: 2022-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
TWA-MAP< 65 mmHg	Intraoperatively	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).
Number of intraoperative hypotension episodes	Intraoperatively	defined as an event of MAP \< 65 mmHg of at least 1-minute duration
Total time of hypotension per case	Intraoperatively	Intraoperative Total time of hypotension (MAP \< 65 mmHg)

Secondary Outcome Measures

Name	Time	Method
StO2	Intraoperatively	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
Postoperative complications	Postoperatively	The analysis of postoperative complications will be carried out in accordance with European EPCO recommendations.
Acute kidney stress biomarkers	NC1: after anestesic induction // NC2: First 4 hours after the patient is admitted to the UCI/REA // NC3: 12 hours after NC2.	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.
Accumulated dose during the intraoperative period of vasoactive	Intraoperatively	Specify by drugs used and method of infusion (bolus / continuous infusion pump)
Need and accumulated dose of drugs not included in previous groups	Intraoperatively	Dexmedetomidine, esmolol or other drugs with hemodynamic impact
Transfusion of total blood products during surgery	Intraoperatively
Length of hospital stay	At 30 days
Mortality	At 30 days
Accumulated dose of Fentanyl, remifentanyl and/or morphine.	Intraoperatively	Accumulated dose during the intraoperative period
Accumulated dose during the intraoperative period of ionotopic drug	Intraoperatively	In case of indication.
Total fluid therapy during surgery	Intraoperatively	Types and total amounts

Trial Locations

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

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain