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Completed

NCT Number: NCT04803903

HPI Index With GDHT in Predicting Hypotension In General Anesthesia Patients

The study will investigate whether the use of Goal Directed Hemodynamic Therapy implemented with the HPI algorithm using a treatment algorithm will reduce the incidence of hypotension and improve treatment of hypotension.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Attikon University Hospital

Athens, Attica, 12461, Greece

About this study

The perioperative period is characterized by hemodynamic instability. Intraoperative hypotension (IOH) can be caused by anesthesia drugs, surgical manipulations, hypovolemia or inhibition of the sympathetic nervous system and impairment of baroreflex regulatory mechanisms. In a retrospective analysis performed at the Cleveland Clinic, the risk for acute kidney injury (AKI) and myocardial injury (MI) increased when mean arterial pressure (MAP) was less than 55 mmHg. Further, even short durations of intraoperative hypotension were associated with AKI and MI. Salmasi and coll analyzed whether associations based on relative thresholds were stronger than those based on absolute thresholds regarding blood pressure. They found that there were no clinically important interactions between preoperative blood pressures and the relationship between hypotension and ΜΙ or ΑΚΙ at intraoperative mean arterial blood pressures less than 65 mmHg. Absolute and relative thresholds had comparable ability to discriminate patients with ΜΙ or ΑΚΙ from those without it. The authors concluded that anesthetic management can thus be based on intraoperative pressures without regard to preoperative pressure. In a retrospective cohort study Sun and coll conclude that an increased risk of postoperative stage I AKI occurs when intraoperative MAP was less than 60 mmHg for more than 20 min and less than 55 mmHg for more than 10 min.

Hence it is fundamental for the management of any hemodynamically unstable patient the rapid assessment of the factors that determine the cardiovascular collapse, followed by prompt treatment and, ultimately, reversal of the responsible process. Recently a Hypotension Probability Indicator (HPI) algorithm has been developed from Edwards Lifesciences using continuous invasively-measured arterial waveforms to predict hypotension with high accuracy minutes before blood pressure actually decreases. The HPI algorithm can be integrated with a goal-directed hemodynamic treatment (GDHT) to achieve hemodynamic optimization by increasing global blood flow and prevent organ failure. We developed a treatment protocol implementing HPI with GDHT that can be used in general anesthesia patients to guide clinical practice.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18 years or older
  • Planned to receive general anaesthesia > 2h
  • Planned to receive an arterial line during surgery
  • Aim for MAP of ≥ 65 mmHg during surgery
  • Being able to give written informed consent prior to surgery

Exclusion criteria

  • Aim for MAP other than 65 mmHg at discretion treating physician
  • Significant hypotension before surgery defined as a MAP <65
  • Right- or left sided cardiac failure (e.g. LVEF<35%)
  • Known cardiac shunts (significant)
  • Known aortic stenosis (severe)
  • Severe cardiac arrhythmias including atrial fibrillation
  • Requiring dialysis
  • Liver surgery with Pringle maneuver
  • Vascular surgery with clamping of the aorta

Treatment and study plan

Flotraq Sensor with EV1000 incorporating the HPI algorithm

Device

The HPI algorithm is only available on the EV1000, Hemosphere and Flotrac monitoring systems and requires the use of a Flotrac sensor connected to an arterial line (Edwards Lifesciences Corp., Irvine, CA, USA). The Flotrac sensor has a splitter which enables the splitting of the arterial blood pressure signal to facilitate a blood pressure signal on both the anesthesia machine monitor (standard care) and the HemoSphere monitor (study).

In the intervention arm we asked the anesthesiologist and anesthesia nurse to use the study treatment flowchart . If the HPI alarm goes off, which entails both a sound and a flickering light, we ask the anesthesiologist to act upon this alarm immedietaly. Use of the study treatment flowchart ensures that the anesthesiologist has to think about the underlying cause. The HemoSphere/EV1000 with HPI software has a second screen with variables that provide information about the underlying cause of the predicted hypotension.

Primary outcomes

  1. TWA hypotension (measured with Flotrac sensor)

    Time frame: intraoperative, starting 15 minutes after induction

    Time weighted average spent in hypotension, defined as MAP <65mmHg for ≥1min

Secondary outcomes

  1. Incidence of hypotension (measured with Flotrac sensor)

    Time frame: intraoperative, starting 15 minutes after induction

    Incidence of hypotension, defined as MAP <65mmHg for ≥1min

  2. Time spent in hypotension (measured with Flotrac sensor)

    Time frame: intraoperative, starting 15 minutes after induction

    Time spent in hypotension, in minutes, defined as MAP <65mmHg for ≥1min

  3. Treatment choice (drugs/fluids)

    Time frame: intraoperative, starting 15 minutes after induction

    Medication used to prevent/treat hypotension. A study member is present at the OR to make notes

  4. Treatment dose (drugs/fluids)

    Time frame: intraoperative, starting 15 minutes after induction

    Dose of medication used to prevent/treat hypotension. A study member is present at the OR to make notes

  5. Time to treatment (drugs/fluids)

    Time frame: intraoperative, starting 15 minutes after induction

    time to treatment of hypotension, defined as MAP <65mmHg for ≥1min.

  6. Diagnostic guidance protocol deviations

    Time frame: intraoperative, starting 15 minutes after induction

    Diagnostic guidance protocol deviations, a study member is present at the OR to make notes of any protocol deviations.

  7. Postoperative Morbidity

    Time frame: postoperative, up to 30 days after surgery or until discharge from the hospital

    Incidence of complications: cardiac, pulmonary, renal

  8. Postoperative Creatinine levels

    Time frame: postoperative, up to 30 days after surgery or until discharge from the hospital

    Measurement if creatinine levels postoperatively

  9. Mortality

    Time frame: postoperative, up to 30 days after surgery

    Incidence of mortality 30 days after surgery

Sponsors and collaborators

Lead sponsor

Attikon Hospital

Other

Registry information

Official study title

Is The Hypotension Probability Indicator With Goal Directed Haemodynamic Treatment Useful In Predicting And Treating Hypotension In General Anesthesia Patients?

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 18, 2021
Registry last updated
Jul 30, 2021

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.

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