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The Predict H Trial

Primary Purpose

Intraoperative Hypotension

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Hemosphere platform® together with the FloTrac Acumen IQ® sensor
Hemosphere platform® together with the FloTrac® sensor
Sponsored by
Juan Victor Lorente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intraoperative Hypotension focused on measuring goal directed hemodynamic therapy, machine learning, acute kidney injury

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario de Jerez de la Frontera
  • Hospital Universitario de Badajoz
  • Hospital Universitario Juan Ramón Jiménez
  • Hospital Universitario Infanta Leonor
  • Hospital Universitario Virgen del Rocío

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental

Control

Arm Description

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®).

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®).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
Postoperative complications
The analysis of postoperative complications will be carried out in accordance with European EPCO recommendations.
Length of hospital stay
Mortality
Total fluid therapy during surgery
Types and total amounts
Accumulated dose of Fentanyl, remifentanyl and/or morphine.
Accumulated dose during the intraoperative period
Accumulated dose during the intraoperative period of vasoactive
Specify by drugs used and method of infusion (bolus / continuous infusion pump)
Accumulated dose during the intraoperative period of ionotopic drug
In case of indication.
Need and accumulated dose of drugs not included in previous groups
Dexmedetomidine, esmolol or other drugs with hemodynamic impact
Transfusion of total blood products during surgery

Full Information

First Posted
February 19, 2020
Last Updated
December 7, 2022
Sponsor
Juan Victor Lorente
Collaborators
Edwards Lifesciences
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1. Study Identification

Unique Protocol Identification Number
NCT04301102
Brief Title
The Predict H Trial
Official Title
Intraoperative Hemodynamic Optimization Using the Hypotension Prediction Index and Its Impact of Tissular Perfusion
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Juan Victor Lorente
Collaborators
Edwards Lifesciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Hypotension
Keywords
goal directed hemodynamic therapy, machine learning, acute kidney injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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®).
Arm Title
Control
Arm Type
Other
Arm Description
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®).
Intervention Type
Device
Intervention Name(s)
Hemosphere platform® together with the FloTrac Acumen IQ® sensor
Intervention Description
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
Intervention Name(s)
Hemosphere platform® together with the FloTrac® sensor
Intervention Description
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 ...).
Primary Outcome Measure Information:
Title
TWA-MAP< 65 mmHg
Description
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
Title
Number of intraoperative hypotension episodes
Description
defined as an event of MAP < 65 mmHg of at least 1-minute duration
Time Frame
Intraoperatively
Title
Total time of hypotension per case
Description
Intraoperative Total time of hypotension (MAP < 65 mmHg)
Time Frame
Intraoperatively
Secondary Outcome Measure Information:
Title
StO2
Description
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
Title
Acute kidney stress biomarkers
Description
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.
Title
Postoperative complications
Description
The analysis of postoperative complications will be carried out in accordance with European EPCO recommendations.
Time Frame
Postoperatively
Title
Length of hospital stay
Time Frame
At 30 days
Title
Mortality
Time Frame
At 30 days
Title
Total fluid therapy during surgery
Description
Types and total amounts
Time Frame
Intraoperatively
Title
Accumulated dose of Fentanyl, remifentanyl and/or morphine.
Description
Accumulated dose during the intraoperative period
Time Frame
Intraoperatively
Title
Accumulated dose during the intraoperative period of vasoactive
Description
Specify by drugs used and method of infusion (bolus / continuous infusion pump)
Time Frame
Intraoperatively
Title
Accumulated dose during the intraoperative period of ionotopic drug
Description
In case of indication.
Time Frame
Intraoperatively
Title
Need and accumulated dose of drugs not included in previous groups
Description
Dexmedetomidine, esmolol or other drugs with hemodynamic impact
Time Frame
Intraoperatively
Title
Transfusion of total blood products during surgery
Time Frame
Intraoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hospital Universitario de Jerez de la Frontera
City
Jerez De La Frontera
State/Province
Cádiz
ZIP/Postal Code
11407
Country
Spain
Facility Name
Hospital Universitario de Badajoz
City
Badajoz
ZIP/Postal Code
06080
Country
Spain
Facility Name
Hospital Universitario Juan Ramón Jiménez
City
Huelva
ZIP/Postal Code
21005
Country
Spain
Facility Name
Hospital Universitario Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data obtained through this study may be provided to qualified researchers with academic interest in sickle cell anemia. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
IPD Sharing Time Frame
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
IPD Sharing Access Criteria
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact juanvictor.lorente@gmail.com
Citations:
PubMed Identifier
35654467
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.
Results Reference
derived

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The Predict H Trial

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