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Table 1 The timeline of the study according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines

From: Abdominal Septic Shock – Endotoxin Adsorption Treatment (ASSET) – endotoxin removal in abdominal and urogenital septic shock with the Alteco® LPS Adsorber: study protocol for a double-blinded, randomized placebo-controlled trial

Assessments

Pre-treatment phase

Treatment phase

Post-treatment phase

Screening

Day 1

Day 2

Days 3–6

ICU discharge

28-day follow-up

Illness criteria

Treatment criteria

Baseline

Following start of treatment 1

End of treatment 1

Prior to treatment 2 start

Start of treatment 2

End of treatment 2

   

up to

−12 h

up to

−6 h

Before 0 h

0 h

6 h

Before 30 h

0 h

6 h

~48–120 h

 

Max 28 days

Enrollment

Informed consent

X

          

Demography, medical history

X

        

X

 

Vital signs, organ support Assessment

X

 

X

X

 

X

X

 

X

  

Physical examination

X

 

X

X

X

X

X

X

X

  

Laboratory assessments

X

 

X

X

X

X

X

X

X

  

Illness severity scoring

X

X

X

X

X

X

X

X

X

X

X

Eligibility criteria #1

X

          

Eligibility criteria #2

 

X

         

Randomization

 

X

         

Intervention

Investigational/placebo device treatment

   

X

 

X

   

Assessments

Laboratory assessments

X

 

X

X

X

X

X

X

X

  

Illness severity scoring

X

X

X

X

X

X

X

X

X

X

X

Prior or concomitant therapy

X

X

X

X

X

X

X

X

X

X

 

AEs

  

X

X

X

X

X

X

X

X

 

ADEs

  

X

X

X

X

X

X

X

X

 

Device deficiencies

  

X

X

 

X

X

    

ICU-LOS

         

X

 

Hospital-LOS

          

X

Mortality (ICU and 28-day)

         

X

X

  1. ADEs adverse device effects, AEs adverse events, ICU intensive care unit, LOS length of stay
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Trials

ISSN: 1745-6215