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NCT Number: NCT05821647

Hypotension Prediction 2 Study in Cardiac Surgery and Postoperative ICU Admission

This trial registration serves as an amendment incorporating the IPD Sharing Statement.

This study already has a trial registration (2021 April 30) in the Netherlands Trial Registry (Reference number NL9449, https://trialsearch.who.int/). However, the NTR register is subject to a merger with another Dutch register. This means that existing registrations are still visible, but can no longer be adjusted.

Study summary:

Hypotension in the operating room (OR) and during post-operative ICU admission is common in surgical patients and even more prevalent in cardiac surgery patients. It is associated with adverse outcomes and while these events are preventable, current management is predominantly reactive. Edwards Lifesciences (Irvine, CA) has developed the Hypotension Prediction Index (HPI), an early warning system that predicts an hypotensive event, defined as MAP below 65 mmHg, with high accuracy minutes before it occurs. At the time of writing the protocol this model has not been tested in a clinical trial in cardiac surgery patients or ICU admitted patients. The aim of the HYPE-2 trial is to assess whether the HPI-algorithm can reduce the time-weighted average (TWA) of intra- and postoperative hypotension in elective on-pump coronary artery bypass graft (CABG) surgery patients.

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Key information

Conditions

Intraoperative Hypotension Cardiovascular Diseases Hypotension Postoperative Hypotension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam University Medical Centers

Amsterdam-Zuidoost, North Holland, 1105 AZ, Netherlands

About this study

Population studied:

All adult patients undergoing elective on-pump CABG surgery or CABG with additional single heart valve surgery (e.g. valve repair or replacement), requiring a radial arterial line and an intended target MAP of 65 mmHg or above during both surgery (excluding cardiopulmonary bypass pump time (CBP)) and during mechanically ventilated phase of duration of ICU admission.

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 at inclusion
  • Planned for elective on-pump CABG surgery or CABG with additional single heart valve surgery (e.g. valve repair or replacement)
  • Planned to receive standard monitoring for cardiac surgery
  • Target MAP of 65 mmHg or above during surgery
  • Target MAP of 65 mmHg or above during the mechanically ventilated phase of ICU admission

Exclusion criteria

  • Known cardiac shunts (significant)
  • Severe cardiac arrhythmias (including but not limited to persistent atrial fibrillation prior to surgery)
  • Expected to receive an hemodynamic assist device (e.g. intra-aortic balloon pump) during surgery
  • Dialysis dependent kidney failure prior to surgery
  • Planned to receive Perioperative Goal Directed Therapy (PGDT) other than standard intraoperative care
  • Previous cardiac surgery in medical history

Treatment and study plan

HPI guided treatment advice

Other

Administer hemodynamic altering intervention aimed at either a preload, contractility, or afterload problem to prevent impending hypotension. Treatment options include: administering either fluids, inotropes, vasopressors, positional changes, or a combination.

Primary outcomes

  1. The overall time-weighted average (TWA) of hypotension (severity of hypotension)

    Time frame: During both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    TWA is a calculation of the depth (in mmHg) of hypotension below the 'threshold' MAP of 65 mmHg x the time spent in hypotension in minutes, this resulting in an 'area'. To better compare this value between different patients the 'area' can be divided by the total duration of the measurement.

Secondary outcomes

  1. Incidence of hypotension

    Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    number of hypotensive events during study phases

  2. Time spent in hypotension

    Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    amount of time in minutes spent in hypotension during study phases

  3. The percentage of time in hypotension

    Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    amount of time in hypotension expressed in percentage of the total study phases' duration

  4. The AUT of a MAP < 65 mmHg

    Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    AUT is a calculation of the depth (in mmHg) of hypotension below the 'threshold' MAP of 65 mmHg x the time spent in hypotension in minutes, this resulting in an 'area'.

  5. Incidence of hypertension

    Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    number of hypertensive events during study phases

  6. Time spent in hypertension

    Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    amount of time in minutes spent in hypertension during study phases

  7. The percentage of time in hypertension

    Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    amount of time in hypertension expressed in percentage of the total study phases' duration

  8. The AAT of a MAP > 100 mmHg

    Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    AAT is a calculation of the depth (in mmHg) of hypertension above the 'threshold' MAP of 100 mmHg x the time spent in hypertension in minutes, this resulting in an 'area'.

  9. TWA of hypertension

    Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    TWA is a calculation of the depth (in mmHg) of hypertension above the 'threshold' MAP of 100 mmHg x the time spent in hypertension in minutes, this resulting in an 'area'. This 'area' is divided by the total duration of the measurement.

  10. Incidence of HPI alarm (HPI ≥ 75)

    Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    number of HPI alarms during study phases

  11. Time spent in HPI alarm

    Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    amount of time in minutes spent in HPI alarms during study phases

  12. The percentage of time in HPI alarm

    Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    amount of time in HPI alarms expressed in percentage of the total study phases' duration

  13. The AAT of a HPI ≥ 75

    Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    AAT is a calculation of the depth of HPI above or equal to the 'threshold' of 75 x the time spent in HPI alarm in minutes, this resulting in an 'area'.

  14. TWA of HPI alarm

    Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    TWA is a calculation of the depth of HPI above or equal to the 'threshold' of 75 x the time spent in HPI alarm in minutes, this resulting in an 'area'. This 'area' is divided by the total duration of the measurement.

  15. Treatment choice

    Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    vasopressors, blood transfusions, fluids, inotropes, position changes, decrease in anesthetics

  16. Treatment dose

    Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    Dosage of medication or volume of fluids

  17. Time to treatment

    Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    If an alarm or hypotensive event had more than 1 treatment, the time to first treatment will be used.

  18. Number of treatments

    Time frame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    amount of treatments (e.g., administered fluids, vasopressors, inotropes, anesthetics) given to alter the hemodynamics (increase of reduce the blood pressure)

Other outcomes

  1. Incidence of hypertension (intraoperative)

    Time frame: During both the off-pump phases of on-pump CABG surgery (or 8 hours maximum)

    number of hypertensive events during the intraoperative study phases

  2. Incidence of hypertension (postoperative in the ICU)

    Time frame: During the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    number of hypertensive events during the ICU study phase

  3. Time spent in hypertension (intraoperative)

    Time frame: During both the off-pump phases of on-pump CABG surgery (or 8 hours maximum)

    amount of time in minutes spent in hypertension during the intraoperative study phases

  4. Time spent in hypertension (postoperative in the ICU)

    Time frame: During the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    amount of time in minutes spent in hypertension during the ICU study phase

  5. TWA of hypertension (intraoperative)

    Time frame: During both the off-pump phases of on-pump CABG surgery (or 8 hours maximum)

    TWA is a calculation of the depth (in mmHg) of hypertension above the 'threshold' MAP of 100 mmHg x the time spent in hypertension in minutes, this resulting in an 'area'. This 'area' is divided by the total duration of the measurement.

  6. TWA of hypertension (postoperative in the ICU)

    Time frame: During the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    TWA is a calculation of the depth (in mmHg) of hypertension above the 'threshold' MAP of 100 mmHg x the time spent in hypertension in minutes, this resulting in an 'area'. This 'area' is divided by the total duration of the measurement.

  7. Incidence of HPI alarm (HPI ≥ 75) (intraoperative)

    Time frame: During both the off-pump phases of on-pump CABG surgery (or 8 hours maximum)

    number of HPI alarms during the intraoperative study phases

  8. Incidence of HPI alarm (HPI ≥ 75) (postoperative in the ICU)

    Time frame: During the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    number of HPI alarms during the ICU study phase

  9. Time spent in HPI alarm (intraoperative)

    Time frame: During both the off-pump phases of on-pump CABG surgery (up to 8 hours)

    amount of time in minutes spent in HPI alarms during the intraoperative study phases

  10. Time spent in HPI alarm (postoperative in the ICU)

    Time frame: During the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    amount of time in minutes spent in HPI alarms during the ICU study phase

  11. TWA of HPI alarm (intraoperative)

    Time frame: During both the off-pump phases of on-pump CABG surgery (or 8 hours maximum)

    TWA is a calculation of the depth of HPI above or equal to the 'threshold' of 75 x the time spent in HPI alarm in minutes, this resulting in an 'area'. This 'area' is divided by the total duration of the measurement.

  12. TWA of HPI alarm (postoperative in the ICU)

    Time frame: During the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    TWA is a calculation of the depth of HPI above or equal to the 'threshold' of 75 x the time spent in HPI alarm in minutes, this resulting in an 'area'. This 'area' is divided by the total duration of the measurement.

  13. Compliance of clinicians to HPI treatment protocol + diagnostic guidance

    Time frame: Will be analyzed for all study phases of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    Assessed by the number of- and reason for protocol deviations: ignored treatment advices.

    The nurse driven hypotension treatment protocol only applies to the ICU nurses

  14. Association between decrease in TWA of hypotension and a difference in creatinine (μmol/L)

    Time frame: Admission at ICU admission, and every morning of hospitalization after surgery (up to 28 days)

    Difference in laboratory value of creatinine between the control and HPI guided treatment group after the surgical procedure

  15. Association between decrease in TWA of hypotension and a difference in lactate (mmol/L)

    Time frame: All lactate samples taken during the study phases and the samples taken every morning during ICU admission (up to 28 days)

    Difference in laboratory value of lactate between the control and HPI guided treatment group

  16. Association between decrease in TWA of hypotension and a difference in creatinine kinase MB (μg/L)

    Time frame: During ICU admission (up to 28 days)

    Difference in laboratory value of creatinine kinase MB between the control and HPI guided treatment group

  17. Association between decrease in TWA of hypotension and a difference in hematocrit (L/L)

    Time frame: During ICU admission (up to 28 days)

    Difference in laboratory value of hematocrit between the control and HPI guided treatment group

  18. Association between decrease in TWA of hypotension and a difference in central venous oxygen saturation (%)

    Time frame: All samples taken during the study phases until the first sample after extubation at ICU (up to 28 days)

    Difference in laboratory value of central venous oxygen saturation between the control and HPI guided treatment group

  19. Association between decrease in TWA of hypotension and a difference in brain natriuretic peptide (ng/L)

    Time frame: During ICU admission (up to 28 days)

    Difference in laboratory value of brain natriuretic peptide between the control and HPI guided treatment group

  20. Sustained effect on TWA of hypotension

    Time frame: After HPI and diagnostic guidance is disconnected up to 8 hours after discontinuation.

    To study whether reducing the severity of hypotension with HPI and diagnostic guidance during both the surgery and the first hours of ICU admission results in a sustained effect after discontinuation of the HPI guided treatment.

  21. Sustained effect on incidence of hypotension

    Time frame: After HPI and diagnostic guidance is disconnected up to 8 hours after discontinuation.

    To study whether reducing the severity of hypotension with HPI and diagnostic guidance during both the surgery and the first hours of ICU admission results in a sustained effect after discontinuation of the HPI guided treatment.

  22. Sustained effect on time spent in hypotension

    Time frame: After HPI and diagnostic guidance is disconnected up to 8 hours after discontinuation.

    To study whether reducing the severity of hypotension with HPI and diagnostic guidance during both the surgery and the first hours of ICU admission results in a sustained effect after discontinuation of the HPI guided treatment.

  23. Difference in treatment behaviour between groups expressed as total number of alarms (n)

    Time frame: Will be analyzed for all study phases of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    To study control group's treatment behaviour after silent alarms to which they were blinded and compare this with treatment behaviour after alarms in the HPI guided treatment group. This analysis focusses on the number of treatments after an early warning system alarm (referred to as 'alarm') but before hypotension occurred. In the HPI guided treatment group the alarms were visible to the treating anesthesiologists. In the control group the alarms were not visible to the treating anesthesiologists. The researchers will compare the total number of alarms (n) between both groups.

  24. Difference in treatment behaviour between groups expressed as number of alarms per patients (n)

    Time frame: Will be analyzed for all study phases of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    To study control group's treatment behaviour after silent alarms to which they were blinded and compare this with treatment behaviour after alarms in the HPI guided treatment group. This analysis focusses on the number of treatments after an early warning system alarm (referred to as 'alarm') but before hypotension occurred. In the HPI guided treatment group the alarms were visible to the treating anesthesiologists. In the control group the alarms were not visible to the treating anesthesiologists. The researchers will compare the number of alarms per patients (n) between both groups.

  25. Difference in treatment behaviour between groups expressed as total percentage of alarms treated (%)

    Time frame: Will be analyzed for all study phases of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    To study control group's treatment behaviour after silent alarms to which they were blinded and compare this with treatment behaviour after alarms in the HPI guided treatment group. This analysis focusses on the number of treatments after an early warning system alarm (referred to as 'alarm') but before hypotension occurred. In the HPI guided treatment group the alarms were visible to the treating anesthesiologists. In the control group the alarms were not visible to the treating anesthesiologists. The researchers will compare the total percentage of alarms treated (%) for each group.

  26. Difference in treatment behaviour between groups expressed as time from alarm to first treatment action (seconds).

    Time frame: Will be analyzed for all study phases of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    To study control group's treatment behaviour after silent alarms to which they were blinded and compare this with treatment behaviour after alarms in the HPI guided treatment group. This analysis focusses on the number of treatments after an early warning system alarm (referred to as 'alarm') but before hypotension occurred. In the HPI guided treatment group the alarms were visible to the treating anesthesiologists. In the control group the alarms were not visible to the treating anesthesiologists. The researchers will compare the time from alarm occurrences to first treatment action (seconds).

  27. Difference in treatment behaviour between groups expressed as time from first alarm to first treatment action (seconds).

    Time frame: Will be analyzed for all study phases of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)

    To study control group's treatment behaviour after silent alarms to which they were blinded and compare this with treatment behaviour after alarms in the HPI guided treatment group. This analysis focusses on the number of treatments after an early warning system alarm (referred to as 'alarm') but before hypotension occurred. In the HPI guided treatment group the alarms were visible to the treating anesthesiologists. In the control group the alarms were not visible to the treating anesthesiologists. The researchers will compare the time from first alarm to first treatment action (seconds).

  28. Assess required treatment during hypotension (MAP < 65 mmHg) within both off-pump phases of on-pump CABG surgery as the determined by the anesthesiologist based on transesophageal echocardiogram (TEE) observations.

    Time frame: During hemodynamic instability (hypotension) within both the off-pump phases of on-pump CABG surgery (or 8 hours maximum)

    Anesthesiologists have the expertise to use TEE observations during hypotensive events to obtain insight in the most likely cause of hypotension: hypovolemia, vasoplegia or reduced ventricular contractility. Each time these observations are obtained the researchers will annotate the determined required treatment.

  29. Assess required treatment during hypotension (MAP < 65 mmHg) within both off-pump phases of on-pump CABG surgery as the determined by the diagnostic guidance protocol.

    Time frame: During hemodynamic instability (hypotension) within both the off-pump phases of on-pump CABG surgery (or 8 hours maximum)

    Prior to the start of the study the researchers designed a diagnostic guidance protocol that integrates parameters obtained from the HemoSphere monitor (i.e., stroke volume, stroke volume variation, systemic vascular resistance, and Dynamic arterial elastance). These parameters provide insight in the most likely cause of forthcoming hypotension: hypovolemia, vasoplegia or reduced ventricular contractility. During hemodynamic instability and hypotension the diagnostic guidance protocl is used to determine the required treatment and will be annotated.

  30. Relation between required treatment as determined by the anesthesiologist's expertise using TEE observations versus the required treatment as determined using the diagnostic guidance protocol.

    Time frame: During hemodynamic instability within both the off-pump phases of on-pump CABG surgery (up to 8 hours)

    As described in the outcome measures 46 and 47, the researchers will assess the required treatments during hemodynamic instability and hypotension. These treatments are determined by the anesthesiologists using TEE observations and simultaneously also by the researchers using the study's diagnostic guidance protocol. Both diagnostic strategies will determine the same treatment options, namely: hypovolemia, vasoplegia or reduced ventricular contractility. The researchers will assess the number of devations in determined treatment.

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Collaborators

  • Edwards Lifesciences

Registry information

Official study title

Effect of a Machine Learning-Derived Early Warning System for Hypotension vs Standard Care on Depth and Duration of Intra- and Postoperative Hypotension in Elective Cardiac Surgery

Acronym: HYPE-2

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 20, 2023
Registry last updated
Apr 20, 2023

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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