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

Not Applicable

Terminated

• Conditions: Emergency; Severe Sepsis; Surgery

• Registration Number: NCT01654003
• Lead Sponsor: University Hospital, Geneva

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2012-07-18
• Study First Submitted QC: 2012-07-27
• Study First Posted: 2012-07-31
• Primary Completion: 2014-06
• Study Completion: 2014-12
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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

Trial Locations

Locations (2)

Emergency operating room, Geneva Cantonal Hospital; 🇨🇭 Geneva, Switzerland

Hôpitaux Universitaires de Genève; 🇨🇭 Genève, Switzerland