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Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter

Primary Purpose

Atrial Fibrillation, Atrial Flutter

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Potassium chloride
Glucose 50 MG/ML
Sponsored by
Diakonhjemmet Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Atrial flutter, Potassium, Cardioversion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with paroxysmal atrial fibrillation/atrial flutter with duration <48 hours
  • Plasma potassium ≤4,0 mmol/L.
  • Age ≥ 18 år

Exclusion Criteria:

  • Plasma potassium > 4,0 mmol/L
  • eGFR <30 mL/min
  • Patients on antiarrhythmic therapy (flecainid, amiodarone, dronedarone or sotalol)
  • Pregnancy
  • Breast feeding
  • Patients participating in a clinical trial during the last six months
  • Addison disease, adynamia episodic hereditary, or Sickle cell anemia
  • Metabolic acidosis, pH < 7,2

Sites / Locations

  • Diakonhjemmet Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Potassium

Placebo

Arm Description

Potassium chloride infusion at a rate of 15 mmol/h (60 mmol KCl in 1000 ml of 5% glucose with a concentration of 0.05 mmol/mL, flow rate 265 mL/h). If the serum Mg ≤0.8 mmol/L, MgSO4 infusion (0.5 mmol/kg/24 hours in 1000 mL NaCl 0.9% corresponding to an infusion rate of approximately 42 mL/hour) will also be administered.

5% glucose (flow rate 265 ml/h) as placebo infusion.

Outcomes

Primary Outcome Measures

Cardioversion (time and percentage)

Secondary Outcome Measures

Atrial fibrillation at 3 months follow up visit and during 72 hours ECG-monitoring period.
The patients will be followed up with a resting ECG about three months after study intervention, and subsequently on-demand ECG will be monitored for 72 hours.

Full Information

First Posted
March 22, 2013
Last Updated
July 29, 2018
Sponsor
Diakonhjemmet Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01818583
Brief Title
Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter
Official Title
Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diakonhjemmet Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Atrial fibrillation is a condition in which the heart's upper chambers, the atria, contract at an abnormally rapid rate. It is a common type of arrhythmia, and occurs in 1-2% of the general population. The prevalence of atrial fibrillation increases with age. Between 50 and 70% of patients with atrial fibrillation lasting <48 hours spontaneously convert to normal sinus rhythm, and drug therapy increases the likelihood of conversion to sinus rhythm. Another treatment option for conversion of atrial fibrillation and atrial flutter is electrical conversion. This is an effective treatment but requires anesthesia. Current treatment strategy for medical conversion of atrial fibrillation and atrial flutter is to employ drugs that affect ion channel activity in atrial cardiomyocytes. However, such converting drugs all have potentially serious side effects and are expensive. Potassium, sodium, calcium, and magnesium molecules are the most important ions causing electric current in the heart tissue. Our hypothesis is that hypokalemia promotes atrial fibrillation/atrial flutter by a direct effect on cardiomyocytes. Accordingly, we also hypothesize that potassium infusion may convert atrial fibrillation/atrial flutter to normal sinus rhythm. If so, this would be an inexpensive treatment with potentially very few side effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Atrial Flutter
Keywords
Atrial fibrillation, Atrial flutter, Potassium, Cardioversion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Potassium
Arm Type
Experimental
Arm Description
Potassium chloride infusion at a rate of 15 mmol/h (60 mmol KCl in 1000 ml of 5% glucose with a concentration of 0.05 mmol/mL, flow rate 265 mL/h). If the serum Mg ≤0.8 mmol/L, MgSO4 infusion (0.5 mmol/kg/24 hours in 1000 mL NaCl 0.9% corresponding to an infusion rate of approximately 42 mL/hour) will also be administered.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
5% glucose (flow rate 265 ml/h) as placebo infusion.
Intervention Type
Drug
Intervention Name(s)
Potassium chloride
Intervention Type
Drug
Intervention Name(s)
Glucose 50 MG/ML
Primary Outcome Measure Information:
Title
Cardioversion (time and percentage)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Atrial fibrillation at 3 months follow up visit and during 72 hours ECG-monitoring period.
Description
The patients will be followed up with a resting ECG about three months after study intervention, and subsequently on-demand ECG will be monitored for 72 hours.
Time Frame
At about 3 months follow up, plus additional 3 days ECG-monitoring
Other Pre-specified Outcome Measures:
Title
Adverse events
Time Frame
During time of infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with paroxysmal atrial fibrillation/atrial flutter with duration <48 hours Plasma potassium ≤4,0 mmol/L. Age ≥ 18 år Exclusion Criteria: Plasma potassium > 4,0 mmol/L eGFR <30 mL/min Patients on antiarrhythmic therapy (flecainid, amiodarone, dronedarone or sotalol) Pregnancy Breast feeding Patients participating in a clinical trial during the last six months Addison disease, adynamia episodic hereditary, or Sickle cell anemia Metabolic acidosis, pH < 7,2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Øie, MD, PhD
Organizational Affiliation
Diakonhjemmet Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Diakonhjemmet Hospital
City
Oslo
ZIP/Postal Code
0370
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31986288
Citation
Tazmini K, Fraz MSA, Nymo SH, Stokke MK, Louch WE, Oie E. Potassium infusion increases the likelihood of conversion of recent-onset atrial fibrillation-A single-blinded, randomized clinical trial. Am Heart J. 2020 Mar;221:114-124. doi: 10.1016/j.ahj.2019.12.014. Epub 2019 Dec 27.
Results Reference
derived

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Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter

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