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

April 14, 2026 updated by: Beijing Anzhen Hospital

Peri-procedural Hydration to Prevent Acute Kidney Injury After Pulsed Field Ablation for Atrial Fibrillation: A Single-Center, Open-Label, Randomized Controlled 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Pulsed field ablation (PFA) has rapidly emerged as a promising non-thermal catheter ablation technology for the treatment of atrial fibrillation (AF). Although its overall safety profile appears favorable, increasing evidence suggests that peri-procedural hemolysis may occur after PFA. In some patients, this hemolysis may contribute to acute kidney injury (AKI), which has become an important safety concern in contemporary PFA practice. Peri-procedural hydration may represent a practical kidney-protective strategy by maintaining renal perfusion and promoting clearance of hemolysis-related pigments and other nephrotoxic factors. However, no randomized controlled trial has evaluated whether routine standardized hydration reduces the risk of AKI after AF ablation with PFA.

The HYDRATE-PFA trial is a single-center, open-label, superiority, parallel-group randomized controlled trial designed to assess whether a standardized peri-procedural hydration strategy can reduce the risk of AKI after PFA for AF. A total of 290 adult patients with symptomatic paroxysmal or persistent AF who are scheduled to undergo PFA will be enrolled at Beijing Anzhen Hospital, Capital Medical University. Participants will be randomized in a 1:1 ratio to either a standardized peri-procedural hydration group, or a control group without routine prophylactic hydration.

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. 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.

For all participants, blood and urine samples will be collected at baseline, immediately after the procedure, and 24 hours after the procedure, with additional in-hospital testing if clinically indicated. Participants will also be followed at 30 days and 90 days after randomization by clinic visit or telephone contact.

The primary endpoint is any in-hospital AKI, defined according to KDIGO criteria (an increase in serum creatinine of at least 0.3 mg/dL within 48 hours or an increase to at least 1.5 times baseline). 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
290

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100029
        • Recruiting
        • Beijing Anzhen Hospitai, Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Participants must meet all of the following criteria:

  • Age ≥18 years.

  • Symptomatic paroxysmal atrial fibrillation (AF) or persistent AF:

    1. Paroxysmal AF: AF that terminates spontaneously or with intervention within 7 days of onset, and meets both of the following:

      1. At least 2 symptomatic paroxysmal AF episodes within 6 months before enrollment;
      2. At least 1 documented AF episode by electrocardiogram (ECG) or Holter monitoring within 12 months before enrollment.

    2. Persistent AF: AF lasting >7 days and ≤365 days, and meets both of the following:

      1. At least 1 symptomatic persistent AF episode within 6 months before enrollment;
      2. Persistent AF documented within 12 months before enrollment by either Holter monitoring or 2 ECGs obtained at least 7 days apart.
  • Failure of antiarrhythmic drug (AAD) therapy, defined as inadequate efficacy and/or intolerance to at least 1 Class I or Class III AAD.
  • Planned to undergo pulsed field ablation (PFA).
  • Willing and able to provide written informed consent.
  • Willing and able to comply with study procedures, including in-hospital assessments and 30-day and 90-day follow-up.

Exclusion Criteria:

Participants meeting any of the following criteria will be excluded:

  • 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.
  • Significant valvular heart disease, including moderate or severe aortic stenosis, severe aortic regurgitation, moderate or severe mitral stenosis, or severe mitral regurgitation.
  • Myocardial infarction within 3 months before enrollment.
  • Cardiac surgery within 3 months before enrollment.
  • New York Heart Association (NYHA) class III or IV congestive heart failure.
  • Left ventricular ejection fraction (LVEF) <35%.
  • Hypertrophic cardiomyopathy.
  • Severe liver disease (Child-Pugh score >7).
  • Stage 4 or 5 chronic kidney disease (eGFR <30 mL/min/1.73 m²).
  • History of kidney transplantation.
  • Need for renal replacement therapy (RRT) at enrollment or any history of prior RRT.
  • Intravascular iodinated contrast administration within 7 days before enrollment.
  • Active systemic infection.
  • Known pregnancy or breastfeeding.
  • Participation in another clinical trial that may affect the results of this study.
  • Unwillingness or inability to comply with study procedures and follow-up, including participants considered by the investigator to be at substantial risk for poor adherence.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: 0.9% sodium chloride
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
In-hospital acute kidney injury
Time Frame: Periprocedural
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.
Periprocedural

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
In-hospital AKI severity
Time Frame: Periprocedural

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).
Periprocedural
In-hospital persistent moderate-to-severe AKI
Time Frame: Periprocedural

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).
Periprocedural
In-hospital renal replacement therapy
Time Frame: Periprocedural
In-hospital renal replacement therapy (RRT) is defined as the initiation of RRT for any reason during hospitalization.
Periprocedural
Absolute and relative changes in serum creatinine and eGFR after the procedure
Time Frame: Periprocedural
Absolute and relative changes in serum creatinine and eGFR from baseline to immediately after the procedure and 24 hours after the procedure.
Periprocedural
30-day mortality
Time Frame: Within 30 days after randomization
Within 30 days after randomization
30-day persistent AKI
Time Frame: Within 30 days after randomization
Defined as a serum creatinine level remaining at least 50% higher than the pre-procedure baseline value at 30 days after randomization.
Within 30 days after randomization
30-day renal replacement therapy
Time Frame: Within 30 days after randomization
Within 30 days after randomization
30-day all-cause rehospitalization
Time Frame: Within 30 days after randomization
Within 30 days after randomization
30-day composite major adverse events
Time Frame: Within 30 days after randomization
Composite of all-cause death, persistent AKI, initiation of RRT, or all-cause rehospitalization within 30 days after randomization.
Within 30 days after randomization
90-day mortality
Time Frame: Within 90 days after randomization
Within 90 days after randomization
90-day persistent AKI
Time Frame: Within 90 days after randomization
Defined as a serum creatinine level remaining at least 50% higher than the pre-procedure baseline value at 90 days after randomization.
Within 90 days after randomization
90-day renal replacement therapy
Time Frame: Within 90 days after randomization
Within 90 days after randomization
90-day all-cause rehospitalization
Time Frame: Within 90 days after randomization
Within 90 days after randomization
90-day composite major adverse events
Time Frame: Within 90 days after randomization
Composite of all-cause death, persistent AKI, initiation of RRT, or all-cause rehospitalization within 90 days after randomization.
Within 90 days after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KS2026035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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