- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01653977
Impact of Early Goal-directed Fluid Therapy in Hypovolemic Patients Undergoing Emergency Surgery
Impact of Early Goal-directed Fluid Therapy in Hypovolemic Patients Undergoing Emergency Surgery A Prospective, Randomised, Open Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Genève, Switzerland, 1211
- Hôpitaux Universitaires de Genève
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults > 18 years
- Severe hypovolemic condition°
- Need for emergent interventional procedure under general anesthesia with an expected duration > 120 min.
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
- Ultra-emergent surgery with no further diagnostic investigation.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: CONTROL
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.
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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.
Other Names:
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Active Comparator: OPTIMIZED
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). |
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).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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).
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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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cerebral complications: stroke
Time Frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
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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.
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Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
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Pulmonary complications: ALI/ARDS, bronchopneumonia
Time Frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
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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.
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Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
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Pulmonary complications: respiratory insufficiency necessitating re-intubation
Time Frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
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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.
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Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
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Surgical complications: re-operation for bleeding or infection
Time Frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
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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.
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Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
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Duration of post-operative mechanical ventilation: in hours
Time Frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
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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.
|
Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
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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.
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Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
|
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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.
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Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
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Mortality
Time Frame: From randomization up to 28 days
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From randomization up to 28 days
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SOFA score measurement
Time Frame: From randomization : day 1, day 2, day 3
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From randomization : day 1, day 2, day 3
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Number of unexpected ICU admission
Time Frame: From randomization up to 28 days
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From randomization up to 28 days
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Cardiovascular complications: myocardial infarct or congestive heart failure
Time Frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
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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.
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Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
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Renal complications: infection, urosepsis or renal insufficiency
Time Frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
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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.
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Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
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Total duration of ventilation : days
Time Frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
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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.
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Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
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Death
Time Frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
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Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gordana Pavlovic, MD, Hôpitaux Universitaires de Genève
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NAC 09-044
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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