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

ConditionsAtrial Fibrillation (AF)Acute Kidney Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Anzhen Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years.

At least 2 symptomatic paroxysmal AF episodes within 6 months before enrollment;

At least 1 documented AF episode by electrocardiogram (ECG) or Holter monitoring within 12 months before enrollment.

At least 1 symptomatic persistent AF episode within 6 months before enrollment;

Disqualifiers

AF due to a reversible cause, such as hyperthyroidism or perioperative/cardiothoracic surgery-related AF.

No oral anticoagulation for at least 3 weeks before ablation.

Intracardiac thrombus.

Contraindication to anticoagulant therapy or iodinated contrast media.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

290 Participants
are divided into 2 treatment groups
Group A: Hydration groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

In-hospital acute kidney injury

Acute kidney injury (AKI) of any severity during hospitalization, meeting any of the following criteria according to KDIGO guidelines: 1) an increase in serum creatinine level of 0.3 mg/dL within 48 hours, or 2) an increase to at least 1.5 times baseline.

Time frame
Periprocedural

Secondary outcomes

1

In-hospital AKI severity

AKI Severity (defined by KDIGO staging): * Stage 1 AKI: Serum creatinine increase ≥0.3 mg/dL or reaching 1.5-1.9 times baseline; * Stage 2 AKI: Serum creatinine reaches 2.0-2.9 times baseline; * Stage 3 AKI: Serum creatinine (SCr) reaches ≥3.0 times baseline, or SCr ≥4.0 mg/dL (≥353.6 μmol/L), or initiation of renal replacement therapy (RRT).

Time frame
Periprocedural
2

In-hospital persistent moderate-to-severe AKI

Persistent moderate-to-severe AKI during hospitalization is defined as KDIGO stage 2-3 AKI lasting ≥48 hours. AKI staging defined by KDIGO guideline: * Stage 1 AKI: Serum creatinine increase ≥0.3 mg/dL or reaching 1.5-1.9 times baseline; * Stage 2 AKI: Serum creatinine reaches 2.0-2.9 times baseline; * Stage 3 AKI: Serum creatinine (SCr) reaches ≥3.0 times baseline, or SCr ≥4.0 mg/dL (≥353.6 μmol/L), or initiation of renal replacement therapy (RRT).

Time frame
Periprocedural
3

In-hospital renal replacement therapy

In-hospital renal replacement therapy (RRT) is defined as the initiation of RRT for any reason during hospitalization.

Time frame
Periprocedural
4

Absolute and relative changes in serum creatinine and eGFR after the procedure

Absolute and relative changes in serum creatinine and eGFR from baseline to immediately after the procedure and 24 hours after the procedure.

Time frame
Periprocedural

Other outcomes

Sponsors and contacts

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Beijing Anzhen Hospital

Lead sponsor

Source ClinicalTrials.gov
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