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Table 2 Secondary variables

From: Prospective, randomized, controlled, double-blind, multi-center, multinational study on the safety and efficacy of 6% Hydroxyethyl starch (HES) sOlution versus an Electrolyte solutioN In patients undergoing eleCtive abdominal Surgery: study protocol for the PHOENICS study

Safety parameters

Efficacy parameters

Other variables

Renal function

• Cystatin-C

• Serum creatinine

• Cystatin-C-based estimated glomerular filtration rate (eGFR)

• Lowest cystatin-C-based eGFR PODs 1–101

• Serum creatinine-based eGFR

• AKIN and RIFLE score2

• Urine output3

Coagulation

• Platelet count

• International normalized ratio

• Activated partial thromboplastin time

Inflammation

• C-reactive protein

Adverse events

• (Serious) adverse events/reactions

Calculated red blood cell loss

Estimated intra-operative blood loss

Outcome

• Composite of mortality and major post-operative complications (including renal) until day 90

• Length of stay (LOS):

LOS in the hospital

LOS in the intensive care unit3

Fit for discharge from ICU/hospital4

• Hours on mechanical ventilation

• In-hospital/out of hospital mortality (including cause)

• (New) renal replacement therapy (RRT)

Fluid administration

• Administration of IP volume

Fluid balance

• Fluid input and output

Hemodynamics/vital signs

• Heart rate

• Temperature

• Mean arterial pressure (MAP)

• Systolic arterial blood pressure

• Diastolic arterial blood pressure

• Central venous pressure3

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 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 saturation3

• Serum electrolytes

Sodium

Potassium

Calcium

Chloride

Major post-operative complications5

Demographic data and medical history

• Age

• Gender

• Height

• Weight

• Ethnicity

• Concomitant diseases and anamnestic baseline characteristics reflecting the surgical risk

• Fluid input in the 24 h prior IP treatment start

Surgery related data

• Main diagnosis leading to surgery

• Type of anesthesia

• Type of surgery

• Time of skin incision/suture

Concomitant medication

• Antibiotic therapy

• Contrast agents

• Diuretics

• Vasoactive/inotropic drugs

• Blood products

• Basal infusion administration

• Crystalloid solutions/albumin

  1. 1Calculated from the highest cystatin-C level during days 1–10, or hospital discharge, whatever occurs first
  2. 2According to Bagshaw et al. 2008 [33]. Reference for the calculation of AKIN and RIFLE scores is the pre-operative creatinine value at baseline; missing baseline creatinine levels will be estimated [18]
  3. 3If applicable/if available
  4. 4According to Marshall et al. 1997 [19]
  5. 5Including renal, defined according to the statement of the ESA-ESICM joint taskforce on perioperative outcome [36]. The classifications of complications into “major” will be done if graded as moderate or severe