Renal Function Post Cardioversion for Atrial Fibrillation (AFCARD-II)

August 5, 2019 updated by: Dan Gilon, Hadassah Medical Organization

Evaluation of Renal Function and Fluid Balance of Patient Undergoing Electrical Cardioversion for Atrial Fibrillation

Atrial fibrillation is a common arrhythmia which requires electrical cardioversion in many patients in order to regain sinus rhythm. In a previous retrospective study a complication of acute renal failure was found in 17% of the patients after cardioversion.(The incidence and prognosis of renal dysfunction following cardioversion of atrial fibrillation. Helman Y,...Gilon D et al:Cardiology 2013;124(3);184-9.) Another complication previously described after cardioversion is pulmonary edema.

In this prospective study the investigators aim to evaluate the risk of acute renal failure post cardioversion. In addition the investigators would like to evaluate hemodynamic changes, fluid balance and sodium levels in patients post cardioversion as a potential mechanism for both acute renal failure and pulmonary edema post cardioversion. In order to assess hemodynamic changes the investigators will use a non-invasive FDA approved device called NICaS (Non-Invasive Cardiac System). This system calculates cardiac output, cardiac index and peripheral vascular resistance in a non-invasive, fast and accurate way.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

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

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Recruiting
        • Hadassah Medical Organization
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dan GILON, MD
        • Sub-Investigator:
          • David LURIA, MD

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with new onset atrial fibrillation. Meaning less than three days.

Description

Inclusion Criteria:

  • All patients with new onset atrial fibrillation

Exclusion Criteria:

  • Pregnant

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational
All comers with Atrial fibrillation
Other: Electrical atrial fibrillation Cardioversion
Electrical cardioversion for patients admitted for Atrial Fibrillation
Other Names:
  • Cardioversion
Other: Cardioversion
Electrical cardioversion for patients admitted for Atrial Fibrillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal dysfunction
Time Frame: Short term - One month
Creatinine Clearance less 25 percent.
Short term - One month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: One year
Death
One year

Collaborators and Investigators

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

Sponsor

Hadassah Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 11, 2018

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

April 9, 2016

First Submitted That Met QC Criteria

April 15, 2016

First Posted (Estimate)

April 18, 2016

Study Record Updates

Last Update Posted (Actual)

August 7, 2019

Last Update Submitted That Met QC Criteria

August 5, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMO-15-0645

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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