NCT07179705

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

Hypotension Prediction Index Guided Prevention of Intradialytic Hypotension During Intermittent Renal Replacement Therapy in Intensive Care Units

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Intradialytic Hypotension
• Intensive Care Unit ICU
• Hemodialysis Patients

Interventions

Type	Name	Description
DEVICE	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.
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)

Timeline

• Start date: 2025-10-10
• Primary completion: 2026-01-31
• Completion: 2026-12-31
• First posted: 2025-09-18
• Last updated: 2025-11-17

Locations

1 site across 1 country: Thailand