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Table 2 Secondary variables

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

Safety parameters

Efficacy parameters

Other variables

Renal function

• Serum creatinine and method of determination (colorimetric or enzymatic)

• Cystatin-C

• Serum creatinine-based eGFR

• Cystatin-C-based eGFRa

• Cystatin-C-based mean eGFR (calculated from the highest cystatin-C level during day 1-3)a

• AKIN scoreb

• RIFLE stageb

• Urine output (if available)

Coagulation

• Platelet count

• International normalized ratio

• Activated partial thromboplastin time

Inflammation

• C-reactive protein

Adverse events

• (Serious) adverse events/reactions

Outcome

• Length of stay (LOS):

□ LOS in the hospital

□ LOS in the intensive care unitc

□ Fulfilment of fit for discharge from ICU/hospitald

• Hours on mechanical ventilation

• In-hospital/out of hospital mortality (incl. cause)

• Days on renal replacement therapy

Fluid administration

• Administration of IP volume

Fluid balance

• Fluid input and output

Hemodynamics/vital signs

• Heart rate

• Mean arterial pressure (MAP)

• Systolic arterial blood pressure

• Diastolic arterial blood pressure

• Central venous pressurec

at least one of the following parameters (volume algorithm):

• Stroke volume (SV)

• Stroke volume variation (SVV)

• Stroke volume index (SVI)

• Pulse pressure variation (PPV)

• Mean arterial blood pressure (MAP)

Laboratory data

• Arterial (preferred) blood gas analysis

□ Partial pressure of carbon dioxide

□ Partial pressure of oxygen

□ Bicarbonate

□ Arterial oxygen saturation

□ pH

□ Base excess

□ Lactate

□ Hemoglobin

□ Hematocrit

Central venous oxygen saturationc

• Serum electrolytes

□ Sodium

□ Potassium

□ Calcium

□ Chloride

Demographic data and medical history

• Age

• Gender

• Height

• Weight

• Ethnicity

• Anamnesis and concomitant diseases (only ongoing and relevant resolved)

• Fluid input from trauma injury until hospital admission

Trauma-related data

• Blunt/penetrating trauma

• Injury characteristics

□ Injury Severity Score

□ Glasgow Coma Scale

Surgery due to traumatic injury

□ Type of surgery

Concomitant medication

• Vasoactive/inotropic drugs

• Amount of transfused blood products [19] including specification (if available)

• Coagulation factors (i.e., fibrinogen/PCC/factor XIII)

• Antibiotic therapy

• Contrast agents

• Diuretics

• Crystalloid solutions/albumin (incl. basal infusion)

  1. aCalculated from highest cystatin-C level on days 1–3, or hospital discharge (whatever occurs first)
  2. bAccording to Bagshaw et al. [24]. Missing baseline creatinine levels will be estimated according to the MDRD equation [22]
  3. cIf applicable/if available
  4. dAs defined by Marshall et al. [25]