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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
20
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.
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).
Hôpitaux Universitaires de Genève
Geneva, Canton of Geneva, Switzerland
Emergency operating room, Geneva Cantonal Hospital
Geneva, Canton of Geneva, Switzerland
Delta lactate
The primary study endpoint will be the difference between the baseline arterial blood lactate at the time of randomization and the value of the arterial blood lactate at the time of transfer from the emergency operating room (∆ lactate).
Time frame: From randomization, for the duration of surgery and up to transfer from the operating room to the ICU or recovery room, an expected average of 6 hours.
Cardiovascular complications: myocardial infarct or congestive heart failure
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.
Time frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first
Cerebral complications: stroke
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.
Time frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
Pulmonary complications: ALI/ARDS, bronchopneumonia
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.
Time frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
Pulmonary complications: respiratory insufficiency necessitating re-intubation
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.
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Time frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
Surgical complications: re-operation for bleeding or infection
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.
Time frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
Renal complications: infection, urosepsis or renal insufficiency
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.
Time frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first
Duration of post-operative mechanical ventilation: in hours
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.
Time frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
Total duration of ventilation : days
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.
Time frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, 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.
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.
Mortality
Time frame: From randomization up to 28 days
SOFA score measurement
Time frame: From randomization : day 1, day 2, day 3
Death
Time frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first
Number of unexpected ICU admission
Time frame: From randomization up to 28 days