Hypotension Prediction 2 Study in Cardiac Surgery and Postoperative ICU Admission

Not Applicable

Completed

• Conditions: Hypotension; Postoperative Hypotension; Intraoperative Hypotension
• Interventions: Other: HPI guided treatment advice

• Registration Number: NCT05821647
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-05-20
• Primary Completion: 2023-02-16
• Study First Submitted: 2023-02-28
• Study Completion: 2023-03-16
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-07
• Last Update Submitted: 2023-04-07
• Study First Posted: 2023-04-20
• Last Update Posted: 2023-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Additional HPI guided treatment	HPI guided treatment advice	Objective to maintain a mean arterial blood pressure (MAP) above or equal to 65 mm Hg, as is standard care in out institution. This is done using standard hemodynamic monitoring (as described for the control group) but is assisted by the Hypotension Prediction Index (HPI). This parameter is made available to the clinicians with the HemoSphere Advanced Monitoring Platform (HemoSphere) and is used to initiate treatment when the HPI values is ≥ 75. It also provides additional advanced hemodynamic variables (e.g. cardiac output, systemic vascular resistance). The treating clinicians are trained to use these variables and are provided with a diagnostic flowchart to determine the cause (preload, contractility and afterload) of the upcoming hypotensive (MAP \< 65 mmHg) event. Timing of treatment and choice of treatment is then left to the discretion of the attending clinician.

Primary Outcome Measures

Name	Time	Method
The overall time-weighted average (TWA) of hypotension (severity of hypotension)	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 Outcome Measures

Name	Time	Method
The AUT of a MAP < 65 mmHg	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'.
Time spent in hypotension	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
The percentage of time in hypotension	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
Time spent in hypertension	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
Treatment choice	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
Treatment dose	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
Incidence of hypotension	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
The AAT of a HPI ≥ 75	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'.
Incidence of HPI alarm (HPI ≥ 75)	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
Time to treatment	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.
Incidence of hypertension	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
The percentage of time in hypertension	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
Time spent in HPI alarm	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
The percentage of time in HPI alarm	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
The AAT of a MAP > 100 mmHg	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'.
TWA of hypertension	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.
TWA of HPI alarm	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.
Number of treatments	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)

Trial Locations

Locations (1)

Amsterdam University Medical Centers; 🇳🇱 Amsterdam-Zuidoost, Noord-Holland, Netherlands