Skip to main content
OpenTrials
Completed

NCT Number: NCT04301102

The Predict H Trial

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intraoperative Hypotension Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario de Jerez de la Frontera, Jerez de la Frontera, Cádiz, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hemosphere platform® together with the FloTrac Acumen IQ® sensor

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 ...).

Hemosphere platform® together with the FloTrac® sensor

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 ...).

Primary outcomes

  1. TWA-MAP< 65 mmHg

    Time frame: 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).

  2. Number of intraoperative hypotension episodes

    Time frame: Intraoperatively

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

  3. Total time of hypotension per case

    Time frame: Intraoperatively

    Intraoperative Total time of hypotension (MAP < 65 mmHg)

Secondary outcomes

  1. StO2

    Time frame: 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

  2. Acute kidney stress biomarkers

    Time frame: 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.

  3. Postoperative complications

    Time frame: Postoperatively

    The analysis of postoperative complications will be carried out in accordance with European EPCO recommendations.

  4. Length of hospital stay

    Time frame: At 30 days

  5. Mortality

    Time frame: At 30 days

  6. Total fluid therapy during surgery

    Time frame: Intraoperatively

    Types and total amounts

  7. Accumulated dose of Fentanyl, remifentanyl and/or morphine.

    Time frame: Intraoperatively

    Accumulated dose during the intraoperative period

  8. Accumulated dose during the intraoperative period of vasoactive

    Time frame: Intraoperatively

    Specify by drugs used and method of infusion (bolus / continuous infusion pump)

  9. Accumulated dose during the intraoperative period of ionotopic drug

    Time frame: Intraoperatively

    In case of indication.

  10. Need and accumulated dose of drugs not included in previous groups

    Time frame: Intraoperatively

    Dexmedetomidine, esmolol or other drugs with hemodynamic impact

  11. Transfusion of total blood products during surgery

    Time frame: Intraoperatively

Sponsors and collaborators

Lead sponsor

Juan Victor Lorente

Other

Collaborators

  • Edwards Lifesciences

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 10, 2020
Registry last updated
Dec 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.