Emergency, Severe Sepsis, Surgery
Conditions
Keywords
Goal-directed therapy, severe sepsis, emergency surgery, vasopressor, dynamic flow-related parameters
Brief summary
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.
Interventions
OTHERCONTROL
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.
OTHEROPTIMIZED
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).
Sponsors
University Hospital, Geneva
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delta lactate | 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. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral complications: stroke | Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first. | 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 | Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first. | 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 | Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first. | 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 | Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first. | 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 | Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first | 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 | Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first. | 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. |
| Cardiovascular complications: myocardial infarct or congestive heart failure | Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first | 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. |
| Length of stay in the ICU: in days | 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 | Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first. | — |
| Mortality | From randomization up to 28 days | — |
| SOFA score measurement | From randomization : day 1, day 2, day 3 | — |
| Death | 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 | From randomization up to 28 days | — |
| Total duration of ventilation : days | Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first | 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. |
Countries
Switzerland
Outcome results
None listed