Peri-procedural Hydration to Prevent Acute Kidney Injury After Pulsed Field Ablation for Atrial Fibrillation

Sponsor
Beijing Anzhen Hospital
Study ID
NCT07490808
Status
Recruiting
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Conditions

  • Acute Kidney Injury
  • Atrial Fibrillation (AF)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 0.9% sodium chloride — DRUG
    Participants assigned to the hydration group will receive 0.9% sodium chloride intravenously at 2 mL/kg/h starting when the participant enters the electrophysiology laboratory and continuing until 12 hours after the procedure. The infusion rate may be reduced or interrupted if there is evidence of fluid overload, hypoxemia, pulmonary congestion, or any other safety concern judged by the investigator.

Study Details

PFA is an emerging non-thermal ablation technology with favorable procedural safety; however, recent studies have raised concerns about peri-procedural hemolysis and subsequent AKI after PFA. This study is a single-center, open-label, randomized controlled trial designed to evaluate whether standardized peri-procedural intravenous hydration can reduce the risk of acute kidney injury (AKI) after pulsed field ablation (PFA) for atrial fibrillation (AF). Eligible adult patients with symptomatic paroxysmal or persistent AF scheduled for PFA will be randomly assigned in a 1:1 ratio to either a standardized hydration strategy or a control strategy without routine prophylactic hydration. The hydration group will receive 0.9% saline at 2 mL/kg/h from entry into the electrophysiology laboratory until 12 hours after the procedure, while the control group will receive no routine preventive hydration and will be treated with fluids only if clinically indicated. The primary outcome is any in-hospital AKI defined according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Secondary endpoints include in-hospital AKI severity by KDIGO stage, in-hospital persistent moderate-to-severe AKI, in-hospital renal replacement therapy, changes in renal function after the procedure, and clinical outcomes through 30 and 90 days, including all-cause death, persistent AKI, renal replacement therapy, all-cause rehospitalization, and composite major adverse events.

Key Dates

First listed
Mar 24, 2026
Start date
Mar 20, 2026
Status verified
Apr 2026
Primary completion
Jul 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
290 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Hydration group
    Participants assigned to the hydration group will receive 0.9% sodium chloride intravenously at 2 mL/kg/h starting when the participant enters the electrophysiology laboratory and continuing until 12 hours after the procedure. The infusion rate may be reduced or interrupted if there is evidence of fluid overload, hypoxemia, pulmonary congestion, or any other safety concern judged by the investigator.
  • No Intervention: Control group
    Participants assigned to the control group will not receive routine preventive hydration; intravenous fluids may be given only when clinically indicated, such as for suspected hemoglobinuria, rising serum creatinine, oliguria.

Primary Outcome Measure

In-hospital acute kidney injury [ Time Frame: Periprocedural ]

Central Contacts

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