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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.