Table 1 PHOENICS study flow diagram
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 | ||||||||||