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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