Clinical Trials Logo
  1. Home
  2. Sepsis
  3. NCT04092621
  4. Details
NCT04092621 Clinical Trial

Rapid Atrial Fibrillation Treatment Strategy

Sepsis Clinical Trial

— RAFTS  

Official title:
Rapid Atrial Fibrillation Treatment Strategy

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04092621
Other study ID # 19-106
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date September 16, 2019
Est. completion date September 15, 2020

Study information
Verified date September 2019
Source Our Lady of the Lake Regional Medical Center
Contact Hollis R O'Neal, MD
Phone 2253812755
Email honeal@lsuhsc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prospective, randomized, open-label clinical trial studying the treatment of new onset atrial fibrillation in critically ill patients with septic shock. Patients will be assigned to rhythm vs rate control strategies with various outcome measures assessed.

Description:

Data have demonstrated that critically ill patients with septic shock who develop atrial fibrillation suffer a greater likelihood of death and other complications when compared with patients who remain in sinus rhythm, however, little evidence exists to inform treatment strategies in this population. Ours is a pilot study evaluating rhythm vs rate control strategies in patients with septic shock and respiratory failure requiring invasive mechanical ventilation who develop new onset atrial fibrillation (NOAF). Design will be prospective, randomized, open-label. Patients in the rhythm control arm will receive IV amiodarone infusion followed by attempt at electrical cardioversion within 24 hours development of NOAF. Those in the rate control arm will receive negative chronotropic agents (beta blockers, calcium channel blockers, amiodarone, or digoxin) at the discretion of the treating physician. Available patient data will be collected for a total of 180 days following enrollment, and outcomes assessed will include ICU length of stay, ventilator free days, and time on vasopressors

Read more »

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Amiodarone in Parenteral Dosage Form
Amiodarone IV
• Amiodarone Pill
Amiodarone tablet
Procedure:
• Direct Current Cardioversion (DCC)
Convert arrhythmia back to sinus rhythm
Drug:
• Rate-control therapy
one or combination of the following: Amiodarone, beta blockers or non-dihydropyridine calcium channel blockers, digoxin

Locations
Country Name City State
United States Our Lady of the Lake Regional Medical Center Baton Rouge Louisiana

Sponsors (1)
Lead Sponsor Collaborator
Our Lady of the Lake Regional Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (12)

See more »

Outcome
Type Measure Description Time frame Safety issue
Primary ICU Length of Stay (LOS) Number of days patient was in the ICU 28 days
Primary Ventilation-free days Days alive and free from mechanical ventilation 28 days
Primary Vasopressor days If vasopressors are administered, number of days patient received vasopressors in the ICU 28 days
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05095324 - The Biomarker Prediction Model of Septic Risk in Infected Patients
Completed NCT02714595 - Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens Phase 3
Completed NCT03644030 - Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
Completed NCT02867267 - The Efficacy and Safety of Ta1 for Sepsis Phase 3
Completed NCT04804306 - Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
Recruiting NCT05578196 - Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections. N/A
Terminated NCT04117568 - The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Completed NCT03550794 - Thiamine as a Renal Protective Agent in Septic Shock Phase 2
Completed NCT04332861 - Evaluation of Infection in Obstructing Urolithiasis
Completed NCT04227652 - Control of Fever in Septic Patients N/A
Enrolling by invitation NCT05052203 - Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Recruiting NCT04005001 - Machine Learning Sepsis Alert Notification Using Clinical Data Phase 2
Completed NCT03258684 - Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock N/A
Recruiting NCT05217836 - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Completed NCT05018546 - Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery N/A
Completed NCT03295825 - Heparin Binding Protein in Early Sepsis Diagnosis N/A
Not yet recruiting NCT06045130 - PUFAs in Preterm Infants
Not yet recruiting NCT05361135 - 18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia N/A
Not yet recruiting NCT05443854 - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01) Phase 3