Skip to main content

Table 4 Schedule for enrollment, interventions, and assessments

From: Furosemide and albumin for diuresis of edema (FADE): a study protocol for a randomized controlled trial

  Study period
  Enrollment Allocation Post-allocation Close-out
Time point Day -1 0 Day 1 Day 2 Day 3 Day 4 Day 5 Day 30
Enrollment
Eligibility screen ×        
Deferred or informed consent ×        
Allocation   ×       
Interventions
Treatment arm    ×/× ×/× ×/×    
Control arm    ×/× ×/× ×/×    
Assessments
Baseline variables
Demographics ×        
Past medical history ×        
Type of diagnosis on admission ×        
APACHE-2 score at randomization ×        
SOFA score at randomization ×        
Diagnosis of ARDS at randomization ×        
Time since hemodynamic stability ×        
Length of ICU stay at randomization ×        
Laboratory results         
Renal function tests    × × × × ×  
Serum chemistry    × × × × ×  
Serum albumin levels    × × × × ×  
Serum total protein levels    ×   ×   ×  
Colloid osmotic pressure    ×   ×   ×  
Blood gas analysis    × × × × ×  
Troponin I levels    × × × × ×  
Serum lactate levels    × × × × ×  
Complete blood count    × × × × ×  
Physiologic data         
Vital signs    × × × × ×  
Glasgow Coma Scale rating    × × × × ×  
Weight    × × × × ×  
Ventilator data    × × × × ×  
Fluid intake and output    × × × × ×  
Diuretic doses and timing    × × × × ×  
Clinical outcomes
Study treatment held?    × × × × ×  
Need for dialysis?    × × × × × ×
Hypotension requiring fluids    × × × × ×  
Hypotension requiring vasopressors    × × × × ×  
Suspected infection?    × × × × ×  
Intubation status    × × × × × ×
Date of transfer from ICU    × × × × × ×
Date of death    × × × × × ×
  1. APACHE-2, Acute Physiology and Chronic Health Evaluation-2; ARDS, acute respiratory distress syndrome; ICU, intensive care unit; SOFA, Sepsis-related Organ Failure Assessment.