Clinical trial NCT01654003: Impact of Early Goal-directed Fluid Therapy in Septic Patients Undergoing Emergency Surgery
Official title: Impact of Early Goal-directed Fluid Therapy in Septic Patients Undergoing Emergency Surgery. A Prospective, Randomised, Open Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Severe Sepsis
Emergency
Surgery
Keywords: Goal-directed therapy
severe sepsis
emergency surgery
vasopressor
dynamic flow-related parameters
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2012-07-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Delta lactate
timeFrame: 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.
Secondary outcomes:
measure: Cardiovascular complications: myocardial infarct or congestive heart failure
timeFrame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first
measure: Cerebral complications: stroke
timeFrame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
measure: Pulmonary complications: ALI/ARDS, bronchopneumonia
timeFrame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
measure: Pulmonary complications: respiratory insufficiency necessitating re-intubation
timeFrame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
measure: Surgical complications: re-operation for bleeding or infection
timeFrame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
measure: Renal complications: infection, urosepsis or renal insufficiency
timeFrame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first
measure: Duration of post-operative mechanical ventilation: in hours
timeFrame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
measure: Total duration of ventilation : days
timeFrame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first
measure: Length of stay in the ICU: in days
timeFrame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
measure: Length of stay in hospital: in days
timeFrame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
measure: Mortality
timeFrame: From randomization up to 28 days
measure: SOFA score measurement
timeFrame: From randomization : day 1, day 2, day 3
measure: Death
timeFrame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first
measure: Number of unexpected ICU admission
timeFrame: From randomization up to 28 days
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Emergency operating room, Geneva Cantonal Hospital
city: Genève
country: Switzerland
facility: Hôpitaux Universitaires de Genève
Study officials:
References: