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Table 1 PHOENICS study flow diagram

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

Procedure Time
Screening: within 1 week before surgery Randomization: max. 1 day prior to surgery T0 (baseline): after randomization and prior induction of anesthesia T1: during surgery T2: end of surgery T3: POD 1 (morning) T4: POD 2 and 3 (morning) T5: POD 4 until POD 7 or hospital discharge, whatever occurs first (morning) T6: POD 8 until POD 10 or hospital discharge, whatever occurs first (morning) T71)/T82) : 28/90 days after surgery T93) 1 year after surgery
Informed consent X           
Inclusion/exclusion criteria X           
Randomization   X          
Demographic data X           
Concomitant diseases (only ongoing and relevant resolved) and anamnestic baseline characteristics reflecting the surgical risk X           
Date of hospital admission X           
Main diagnosis for surgery X           
Type of anesthesia     X        
Type of surgery      X       
Time of skin incision     X        
Time of skin suture      X       
Fluid input (colloids, crystalloids) in the 24 h prior IP treatment start    X        
Temperature [°C]    X   X X X     
Cystatin-C [mg/l]
Cystatin-C-based eGFR [ml/min]
Cystatin-C-based mean eGFR (calculated from the highest cystatin-C level during days 1–10) [ml/min]
SCr [mg/dl]
SCr-based eGFR [ml/min]
AKIN score (calculated)
RIFLE score (calculated)
Urine output (if available)
   X   X X X Only cystatin C-based mean GFR Only cystatin C-based mean GFR X (without urine output)  
C-reactive protein [mg/l]    X   X X      
Platelet count [μ/l]
INR
aPTT [s]
   X   X X      
Na+ [mmol/l]
K+ [mmol/l]
Ca2+ [mmol/l]
Cl- [mmol/l]
   X   X X      
pCO2 [mmHg]
pO2 [mmHg]
HCO3 [mmol/l]
SaO2 [%]
pH
Base excess [mEq/l]
   X   X       
Hb [g/dl]
Hct [%]
   X   X X X     
Lactate [mmol/l]    X   X X X     
ScvO2 [%] (if available)    X   X X      
Administered IP volume [ml]     During the duration of IP administration (max 24 h)      
Fluid input [ml] (every i.v. medication, applied blood products)
Fluid output [ml] (drainage, urine output, estimated intra-operative blood loss)
   Cumulative from T0 until T4     
Estimated intra-operative blood loss [ml]      X       
MAP [mmHg]
HR [beats/min]
   X X* X X# X#     
SAP [mmHg]
DAP [mmHg]
CVP [mmHg] (if available)
   X X* X       
Hemodynamics as required to determine volume responsiveness (at least one variable)
• MAP [mmHg]
• SV [ml]
• SVV [%]
• PPV [%]
• SVI [ml/min2]
    **During duration of IP administration to assess volume responsiveness      
Major post-operative complications (including renal)       X X X X X  
Date and time of hospital discharge (if applicable)       At hospital discharge X  
Fulfilment of fit for discharge from hospital criteria (PADS)       Daily until fulfillment X  
Transfer to ICU/IMC      X       
Date of ICU admission (if applicable)       At ICU admission    
Date and time of discharge from ICU (if applicable)       At ICU discharge X  
Fit for ICU discharge criteria (if applicable)       Daily until fulfillment X  
Use of renal replacement therapy (RRT)      X X X X    
Mechanical ventilation    X X X X X X    
Vasoactive/inotropic drugs
• Administered drug
• Dosage/volume
   Continuously    
Applied blood products
• Administered drug
• Dosage/volume
    Continuously    
Crystalloid/albumin
• Administered drug
• Dosage/volume
    Whenever applied    
Antibiotics
Contrast agents
Diuretics
Basal infusion (volume)
   Whenever applied    
(Serious) adverse events    Continuously  
New RRT           X X
Mortality (in-hospital/out of hospital) and cause      X X X X X X X
Study termination      At termination  
  1. *At least every 30 min
  2. **As required
  3. #MAP if available
  4. 1)± 5 days
  5. 2)± 14 days
  6. 3)± 30 days