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

University Hospitals (UH)

Status: Terminated

Conditions: Surgery; Severe Sepsis; Emergency

Treatments: Other: OPTIMIZED; Other: CONTROL

Study type: Interventional

Funder types: Other

Identifiers

NCT01654003

NAC 09-044 B

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

CONTROL

Active Comparator group

Description:

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.

Treatment:

Other: CONTROL

OPTIMIZED

Active Comparator group

Description:

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).

Treatment:

Other: OPTIMIZED