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

Not Applicable

Not yet recruiting

• Conditions: Intradialytic Hypotension; Intensive Care Unit ICU; Hemodialysis Patients

• Registration Number: NCT07179705
• Lead Sponsor: Chulalongkorn University

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.

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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-21
• Study First Submitted QC: 2025-09-16
• Last Update Submitted: 2025-09-16
• Study First Posted: 2025-09-18
• Last Update Posted: 2025-09-18
• Study Start: 2025-10-01
• Primary Completion: 2026-01-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
- Time-weighted average mean arterial pressure <65 mmHg (TWA-MAP<65 mmHg)	Day 1 and Day 3	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.

Secondary Outcome Measures

Name	Time	Method
Intradialytic hypotension frequency by various definitions	Day 1 and Day 3	* 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
Delivered UF/Prescribed UF	Day 1 and Day 3	* 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.
Incidence of tachycardia or significant arrhythmia	Day 1and Day 3	Incidence of tachycardia or significant arrhythmia: defined by HR\>130 bpm or HR increase \>20% from pre-hemodialysis baseline for \>15 min
Reaction time to treatment	Day 1 and Day 3	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