Back to resultsImpact of Early Goal-directed Fluid Therapy in Septic Patients Undergoing Emergency Surgery
Primary Purpose
Severe Sepsis, Emergency, Surgery
Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
CONTROL
OPTIMIZED
Sponsored by
About this trial
This is an interventional prevention trial for Severe Sepsis focused on measuring Goal-directed therapy, severe sepsis, emergency surgery, vasopressor, dynamic flow-related parameters
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
Sites / Locations
- Emergency operating room, Geneva Cantonal Hospital
- Hôpitaux Universitaires de Genève
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
CONTROL
OPTIMIZED
Arm Description
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. At the discretion of the attending anaesthesiologist with the FMH level, a pulmonary artery catheter, a transoesophageal Doppler flow probe or the PiCCO monitor will be inserted to complement the standard hemodynamic monitoring if deemed necessary.
In the OPTIMIZED group, the central venous catheter and the 4-French artery catheter (femoral or humeral access site) will be connected to a dedicated haemodynamic monitor (Pulsiocath, PV2024L; Pulsion Medical Systems AG, Munich, Germany). The administration of fluid (250-500ml crystalloids or colloids) and 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).
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
Length of stay in the ICU: in days
Length of stay in hospital: in days
Mortality
SOFA score measurement
Death
Number of unexpected ICU admission
Full Information
NCT ID
NCT01654003
First Posted
July 18, 2012
Last Updated
May 11, 2016
Sponsor
University Hospital, Geneva
1. Study Identification
Unique Protocol Identification Number
NCT01654003
Brief Title
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
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Why Stopped
recrutment difficulties
Study Start Date
April 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis, Emergency, Surgery
Keywords
Goal-directed therapy, severe sepsis, emergency surgery, vasopressor, dynamic flow-related parameters
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CONTROL
Arm Type
Active Comparator
Arm Description
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.
At the discretion of the attending anaesthesiologist with the FMH level, a pulmonary artery catheter, a transoesophageal Doppler flow probe or the PiCCO monitor will be inserted to complement the standard hemodynamic monitoring if deemed necessary.
Arm Title
OPTIMIZED
Arm Type
Active Comparator
Arm Description
In the OPTIMIZED group, the central venous catheter and the 4-French artery catheter (femoral or humeral access site) will be connected to a dedicated haemodynamic monitor (Pulsiocath, PV2024L; Pulsion Medical Systems AG, Munich, Germany).
The administration of fluid (250-500ml crystalloids or colloids) and 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).
Intervention Type
Other
Intervention Name(s)
CONTROL
Other Intervention Name(s)
standard care, fluide therapy, vasopressor, sepsis
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
OPTIMIZED
Other Intervention Name(s)
GDT fluide therapy, Picco
Intervention Description
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).
Primary Outcome Measure Information:
Title
Delta lactate
Description
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.
Secondary Outcome Measure Information:
Title
Cardiovascular complications: myocardial infarct or congestive heart failure
Description
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
Title
Cerebral complications: stroke
Description
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.
Title
Pulmonary complications: ALI/ARDS, bronchopneumonia
Description
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.
Title
Pulmonary complications: respiratory insufficiency necessitating re-intubation
Description
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.
Title
Surgical complications: re-operation for bleeding or infection
Description
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.
Title
Renal complications: infection, urosepsis or renal insufficiency
Description
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
Title
Duration of post-operative mechanical ventilation: in hours
Description
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.
Title
Total duration of ventilation : days
Description
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
Title
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.
Title
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.
Title
Mortality
Time Frame
From randomization up to 28 days
Title
SOFA score measurement
Time Frame
From randomization : day 1, day 2, day 3
Title
Death
Time Frame
Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first
Title
Number of unexpected ICU admission
Time Frame
From randomization up to 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Emergency operating room, Geneva Cantonal Hospital
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Hôpitaux Universitaires de Genève
City
Genève
ZIP/Postal Code
12011
Country
Switzerland
12. IPD Sharing Statement
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Impact of Early Goal-directed Fluid Therapy in Septic Patients Undergoing Emergency Surgery
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