Hypotension Prediction 2 Study in Cardiac Surgery and Postoperative ICU Admission

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-20

Study Completion Date

2023-03-16

Brief Summary

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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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Detailed Description

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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.

Conditions

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Intraoperative Hypotension Postoperative Hypotension Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study has two arms in which patients are allocated in a 1:1 randomization ratio.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

The patient and the researcher performing the analysis are blinded. Because of the nature of the interventions, the investigators and treating anesthesiologist, anaesthesia nurse, intensivist and critical care nurse will not be masked to group allocation.

Study Groups

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Control group

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, which in our center consists of continuous arterial blood pressure monitoring and the pulse pressure variation parameter. The clinician will administer either fluids, inotropes, vasopressors, or a combination, or apply positional changes to maintain the set MAP threshold.

Group Type NO_INTERVENTION

No interventions assigned to this group

Additional HPI guided treatment

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.

Group Type EXPERIMENTAL

HPI guided treatment advice

Intervention Type 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.

Interventions

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HPI guided treatment advice

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No