Using a Hypotension Prediction Index to Prevent Low Blood Pressure During Dialysis in ICU Patients

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

RECRUITING

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-10

Study Completion Date

2026-12-31

Brief Summary

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This single-center, crossover randomized controlled trial (HyPIR-ICU) investigates whether a Hypotension Prediction Index (HPI)-guided management strategy can reduce intradialytic hypotension (IDH) during prolonged intermittent renal replacement therapy (PIRRT) in critically ill patients. All participants must have an indwelling arterial catheter for continuous hemodynamic monitoring.

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Detailed Description

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This study explores whether HPI-guided management during PIRRT can randomization: Block randomization stratified by kidney status (AKI vs. ESKD) and vasopressor use. All parameters are monitored in real-time via the HemosphereⓇ system and reassessed after each intervention.

Conditions

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Intradialytic Hypotension Intensive Care Unit ICU Hemodialysis Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Study Design

* Crossover design: Each participant receives both interventions (HPI-guided and standard care) during two dialysis sessions, with a 1-2 day washout between sessions.
* Randomization: Block randomization stratified by kidney status (AKI vs. ESKD) and vasopressor use.
* Open-label: Clinicians and participants are aware of the treatment; however, data analysis is blinded and performed independently.

Intervention Arm A: HPI-guided management during first PIRRT → standard care in second session Arm B: Standard care during first PIRRT → HPI-guided management in second session

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Clinicians and participants are aware of the treatment; however, data analysis is blinded and performed independently.

Study Groups

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HPI first

Arm A: HPI-guided management during first PIRRT → standard care in second session

Group Type EXPERIMENTAL

Hypotensive prediction index

Intervention Type DEVICE

The HPI, developed by Edwards Lifesciences and integrated into the HemosphereⓇ hemodynamic monitoring system, is an algorithm-based tool that predicts hypotensive events before they occur, allowing earlier intervention. While this tool has shown benefit in surgical and post-operative settings, it has not been tested in ICU patients undergoing dialysis.

Standard of care first

Arm B: Standard care during first PIRRT → HPI-guided management in second session

Group Type EXPERIMENTAL

Standard of care monitoring

Intervention Type DEVICE

Standard of Care

* Monitoring via conventional invasive BP and clinical judgment
* Use of physical exam, CVP, PPV, and response-based decisions (fluid bolus, vasopressors)

Interventions

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Hypotensive prediction index

The HPI, developed by Edwards Lifesciences and integrated into the HemosphereⓇ hemodynamic monitoring system, is an algorithm-based tool that predicts hypotensive events before they occur, allowing earlier intervention. While this tool has shown benefit in surgical and post-operative settings, it has not been tested in ICU patients undergoing dialysis.

Intervention Type DEVICE

Standard of care monitoring

Standard of Care

* Monitoring via conventional invasive BP and clinical judgment
* Use of physical exam, CVP, PPV, and response-based decisions (fluid bolus, vasopressors)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adults \>18 years old
* Diagnosed with acute kidney injury (AKI) or end-stage kidney disease (ESKD)
* Admitted to medical ICU
* Scheduled for PIRRT
* Have an indwelling arterial catheter

Exclusion Criteria

* Severe right heart dysfunction, significant valvular disease, arrhythmias, mechanical circulatory support, absence of arterial access, no UF prescription, palliative care, or expected ICU stay \<72 hours.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No