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Table 1 TETHYS study flow diagram

From: PragmaTic, prospEctive, randomized, controlled, double-blind, mulTi-centre, multinational study on the safety and efficacy of a 6% HydroxYethyl Starch (HES) solution versus an electrolyte solution in trauma patients: study protocol for the TETHYS study

 

Time

Screening: at hospital admission

T0 (baseline): emergency room until IP treatment start

T1: First 24 h after IP treatment startb

T2: post-traumatic day 1b-3 (morning)

T3: post-traumatic day 4-7 (morning)

T4c: day 90 after randomization

Procedure

 Inclusion/exclusion criteria

X

     

 Randomization

 

X

    

 Demographic data and medical history

X

     

 Anamnesis and concomitant diseases (only ongoing and relevant resolved)

X

     

 Date and time of hospital admission

X

     

 Blunt/penetrating trauma

X

     

 Injury characteristics

X

     

 Fluid input (colloids, crystalloids) after trauma injury and until hospital admission

X

     

Surgery due to traumatic injury

• Type of surgery

• Date

• Time of skin incision/time of skin suture

  

X

X

X

 

SCr [mg/dl]

SCr-based eGFR [ml/min]

Cystatin-C [mg/dl]

Cystatin-C based eGFR [ml/min]

Cystatin-C-based mean eGFR [ml/min] (calculated from the highest cystatin-C level during days 1–3)

AKIN score (calculated)

Highest AKIN stage reached on each day (during the first week) (calculated)

RIFLE score (calculated)

Urine output (if available)

 

X

Xa

X

Xd

 

C-reactive protein [mg/L]

 

X

Xa

X

  

Platelet count [μ/L]

INR

aPTT [s]

 

X

Xa

X

  

pCO2 [mmHg]

pO2 [mmHg]

HCO3- [mmol/l]

SaO2 [%]

pH

Base excess [mEq/l]

Hb [g/dl]

Hct [%]

Lactate [mmol/l]

 

X

Xa

X

  

ScvO2 [%] (if available)

 

X

Xa

X

  

Na+ [mmol/l]

K+ [mmol/l]

Ca2+ [mmol/l]

Cl- [mmol/l]

 

X

Xa

X

  

Administered IP volume [19]

 

X

X

   

Fluid input [19]

(incl. every i.v. medication, applied blood products)

Fluid output [19]

(incl. drainage, urine output, estimated blood loss)

 

X

X

X

X

 

Temperature [°C]

 

X

X

X

X

 

MAP [mmHg] (calculated)

HR [beats/min]

SAP [mmHg]

DAP [mmHg]

CVP [mmHg] (if available)

 

X

Xa

X

X

 

Hemodynamics as required to determine volume responsiveness

(one variable if applicable)

• MAP [mmHg]

• SV [19]

• SVV [%]

• PPV [%]

• SVI [ml/min2]

 

During duration of IP administration to assess volume responsiveness

   

Mechanical ventilation

X

X

X

X

X

 

Use of RRT

  

X

X

X

X

Antibiotics

Contrast agents

Diuretics

 

X

X

X

X

 

Crystalloid (including basal infusion)/albumin

• Administered drug

• Volume

 

X

X

X

X

 

Vasoactive/inotropic drugs

• Administered drug

• Dosage/volume

 

X

X

X

X

 

Fibrinogen/PCC/factor XIII

• Administered drug

• Dosage/volume

 

X

X

X

X

 

Applied blood products [19]

• Administered drug

• Dosage/volume

 

X

X

X

X

 

(Serious) adverse events

 

continuously

Date and time of hospital discharge

    

At hospital discharge

Fulfilment of fit for discharge criteria from hospital

    

Daily until fulfilment

X

Date of ICU admission

 

At ICU admission

 

Date and time of discharge from ICU

   

At ICU discharge

Fulfilment of fit for ICU discharge criteria

   

Daily until fulfilment

X

Mortality (in-hospital/out of hospital)

   

X

X

X

Study termination

 

At termination

  1. aAt least every 6 h
  2. bIn case assessment of time points T1 and T2 (day 1) are within a timespan of max. 2 h only one assessment per variable has to be done to minimize intervention for the patient, otherwise deemed clinically required
  3. cA lag time of ± 14 days for the conduct of this follow-up contact is accepted, to account difficulties in obtaining data due to potential causes for delay (e.g., mail delay, or patient´s inability to travel)
  4. dexcept cystatin-C
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Trials

ISSN: 1745-6215