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

NCT07179705 | Recruiting

• 1 other identifier: 0204/68
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intradialytic Hypotension; Intensive Care Unit ICU; Hemodialysis Patients

Keywords

Hypotension Prediction Index (HPI); Prolonged intermittent renal replacement therapy (PIRRT); Slow-low efficiency dialysis; Intradialytic hypotension; Hemodynamic monitoring; Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• - 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.

  Day 1 and Day 3

Secondary Outcomes (4)

• Intradialytic hypotension frequency by various definitions

  Day 1 and Day 3

• Delivered UF/Prescribed UF

  Day 1 and Day 3

• Incidence of tachycardia or significant arrhythmia

  Day 1and Day 3

• Reaction time to treatment

  Day 1 and Day 3

Study Arms (2)

HPI first

EXPERIMENTAL

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

Device: Hypotensive prediction index

Standard of care first

EXPERIMENTAL

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

Device: Standard of care monitoring

Interventions

Hypotensive prediction index 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.

HPI first

Standard of care monitoring 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)

Standard of care first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Division of Nephrology, Faculty of Medicine, Chulalongkorn University

Bangkok, Thailand

RECRUITING

Central Study Contacts

Nattapakorn Mai-on

CONTACT

66970051116; nattapakorn.m@gmail.com

Nuttha Lumlertgul

CONTACT

66855788949; nlumlertgul@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinicians and participants are aware of the treatment; however, data analysis is blinded and performed independently.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: September 18, 2025
• Study Start: October 10, 2025
• Primary Completion: January 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)