Impact of Early Goal-directed Fluid Therapy in Septic Patients Undergoing Emergency Surgery

• Cardiovascular complications: myocardial infarct or congestive heart failure [ Time Frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first ] [ Designated as safety issue: No ]
  Clinical outcome and surrogate biomarkers (Troponin-I and pro-BNP: day 1-2-3) will be recorded by extracting this specific data from the electronic medical file, until discharge, death or up to 28 days, whichever comes first.
• Cerebral complications: stroke [ Time Frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first. ] [ Designated as safety issue: No ]
  Clinical outcomes at day 1-2-3 will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first.
• Pulmonary complications: ALI/ARDS, bronchopneumonia [ Time Frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first. ] [ Designated as safety issue: No ]
  Clinical outcomes at day 1-2-3 will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first.
• Pulmonary complications: respiratory insufficiency necessitating re-intubation [ Time Frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first. ] [ Designated as safety issue: No ]
  Clinical outcomes at day 1-2-3 will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first.
• Surgical complications: re-operation for bleeding or infection [ Time Frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first. ] [ Designated as safety issue: No ]
  Clinical outcomes at day 1-2-3 will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first.
• Renal complications: infection, urosepsis or renal insufficiency [ Time Frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first ] [ Designated as safety issue: No ]
  Clinical outcome and surrogate biomarkers (Riffle score, creatinine: day 1-2-3) will be recorded by extracting this specific data from the electronic medical file, until discharge, death or up to 28 days, whichever comes first.
• Duration of post-operative mechanical ventilation: in hours [ Time Frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first. ] [ Designated as safety issue: No ]
  Clinical outcomes at day 1-2-3 will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first.
• Total duration of ventilation : days [ Time Frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first ] [ Designated as safety issue: No ]
  Clinical outcomes (ventilation free days) will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first.
• Length of stay in the ICU: in days [ Time Frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first. ] [ Designated as safety issue: No ]
• Length of stay in hospital: in days [ Time Frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first. ] [ Designated as safety issue: No ]
• Mortality [ Time Frame: From randomization up to 28 days ] [ Designated as safety issue: No ]
• SOFA score measurement [ Time Frame: From randomization : day 1, day 2, day 3 ] [ Designated as safety issue: No ]
• Death [ Time Frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first ] [ Designated as safety issue: No ]
• Number of unexpected ICU admission [ Time Frame: From randomization up to 28 days ] [ Designated as safety issue: No ]

This study wants to compared the safety and efficacy of GDTs using standard pressure-related parameters vs. dynamic hemodynamic indices associated with fluid compartment monitoring, in septic patients requiring emergency surgery.

• Severe Sepsis
• Emergency
• Surgery

• Other: CONTROL
  In the CONTROL group, the administration of fluid (250-500ml crystalloids or colloids) and cardiovascular supportive drugs will be guided to maintain standard pressure-related parameters within a normal range: MAP > 65mmHg, HR < 90/min, CVP >8-12< cm H20, urinary output > 0.5 ml/kg/h. In line with the conventional approach, other physiological parameters will also be targeted: T° > 35.5°C, Sp02 > 95%, lactate < 2.5 mmol/L, normalisation of the BE. The maximal infused volume of hydroxyethyl starch (Voluven®) will be 33 ml/kg.
  Other Names:

  • standard care
  • fluide therapy
  • vasopressor
  • sepsis
• Other: OPTIMIZED
  In the OPTIMIZED group, the haemodynamic monitor (Pulsiocath)will help to a goal-directed administration of fluid (250-500ml crystalloids or colloids).The cardiovascular supportive drugs will be guided by an algorithm taking into account standard parameters (HR, MAP, lactate, Hb), as well as static and dynamic volumetric parameters (SVI, CI, GEDVI, EVLWI, SVV, PPV, PVI).
  Other Names:

  • GDT fluide therapy
  • Picco

• Active Comparator: CONTROL

  In the CONTROL group, the administration of fluid (250-500ml crystalloids or colloids) and cardiovascular supportive drugs will be guided to maintain standard pressure-related parameters within a normal range: MAP > 65mmHg, HR < 90/min, CVP >8-12< cm H20, urinary output > 0.5 ml/kg/h. In line with the conventional approach, other physiological parameters will also be targeted: T° > 35.5°C, Sp02 > 95%, lactate < 2.5 mmol/L, normalisation of the BE. The maximal infused volume of hydroxyethyl starch (Voluven®) will be 33 ml/kg.

  At the discretion of the attending anaesthesiologist with the FMH level, a pulmonary artery catheter, a transoesophageal Doppler flow probe or the PiCCO monitor will be inserted to complement the standard hemodynamic monitoring if deemed necessary.

  Intervention: Other: CONTROL
• Active Comparator: OPTIMIZED

  In the OPTIMIZED group, the central venous catheter and the 4-French artery catheter (femoral or humeral access site) will be connected to a dedicated haemodynamic monitor (Pulsiocath, PV2024L; Pulsion Medical Systems AG, Munich, Germany).

  The administration of fluid (250-500ml crystalloids or colloids) and cardiovascular supportive drugs will be guided by an algorithm taking into account standard parameters (HR, MAP, lactate, Hb), as well as static and dynamic volumetric parameters (SVI, CI, GEDVI, EVLWI, SVV, PPV, PVI).

  Intervention: Other: OPTIMIZED

Inclusion Criteria:

• Adults > 18 years
• Severe sepsis* as defined by the ACCCP/SCCM consensus conference
• Need for emergent interventional procedure under general anesthesia with an expected duration > 120 min (in and out patients).

Exclusion Criteria:

• Patients responding to early fluid resuscitation (20ml/kg) who don't require a CVC
• Neurotrauma (Glasgow Coma Score < 12) and/ or medullar trauma
• Known pregnancy or diagnosed by US or Ct-scan (> 14 weeks)
• Sustained cardiac arrhythmia (see Logbook P8)
• Known or diagnosed severe cardiac valvular dysfunction (stenosis, insufficiency) (see Logbook P8)
• Known or diagnosed intracardiac shunt: interventricular or atrial defect (see Logbook P8)
• Burn injury > 10%
• Needed emergency thoracotomy or ABC resuscitation protocol
• Pre-existing severe liver dysfunction(Child-Pugh class C)
• Do-not-resuscitate order, died within 48h of admission