Impact of Early Goal-directed Fluid Therapy in Septic Patients Undergoing Emergency Surgery. A Prospective, Randomised, Open Trial

University Hospital, Geneva2 sites in 1 country20 target enrollmentApril 2010

ConditionsSevere Sepsis Emergency Surgery

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Severe Sepsis
Sponsor: University Hospital, Geneva
Enrollment: 20
Locations: 2
Primary Endpoint: Delta lactate
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2010

End Date

December 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Geneva

Responsible Party

Principal Investigator

Pavlovic Gordana, MD

Principal Investigator

University Hospital, Geneva

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

Outcomes

Primary Outcomes

Delta 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.

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 Outcomes

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)
Cerebral complications: stroke(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(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(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(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(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(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(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(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)