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

Chulalongkorn University46 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Intradialytic Hypotension Intensive Care Unit ICU Hemodialysis Patients

Interventions

Hypotensive prediction indexDEVICE

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 monitoringDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

- Time-weighted average mean arterial pressure <65 mmHg (TWA-MAP<65 mmHg)

Average intensity and duration of time that a patient's mean arterial pressure (MAP) falls below 65 mmHg, which is considered the critical threshold for maintaining adequate organ perfusion.

Time frame: Day 1 and Day 3

Secondary Outcomes

Intradialytic hypotension frequency by various definitions

* Nadir90: Minimal intra-hemodialytic SBP\<90 mmHg * Fall20: Pre-hemodialysis SBP - Minimal intra-hemodialytic SBP \>20 mmHg * Fall20Nadir90: Meet criteria for Nadir 90 and Fall20 * HEMO: Fall in SBP resulting in intervention of UF reduction, blood flow reduction, or intervention administration

Time frame: Day 1 and Day 3

Delivered UF/Prescribed UF

* Prescribed UF (Ultrafiltration): The amount of fluid (in milliliters or liters) * Delivered UF: The actual amount of fluid successfully removed during the session. * This ratio reflects the efficacy of fluid removal.

Time frame: Day 1 and Day 3

Incidence of tachycardia or significant arrhythmia

Incidence of tachycardia or significant arrhythmia: defined by HR\>130 bpm or HR increase \>20% from pre-hemodialysis baseline for \>15 min

Time frame: Day 1and Day 3

Reaction time to treatment

Reaction time to treatment refers to the interval between the detection of a hypotensive event (or risk of it) and the initiation of appropriate clinical intervention

Time frame: Day 1 and Day 3

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts