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

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ClinicalTrials.gov Identifier: NCT01654003
Recruitment Status : Terminated (recrutment difficulties)
First Posted : July 31, 2012
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
Pavlovic Gordana, MD, University Hospital, Geneva

Tracking Information
First Submitted Date  ICMJE July 18, 2012
First Posted Date  ICMJE July 31, 2012
Last Update Posted Date May 13, 2016
Study Start Date  ICMJE April 2010
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2012)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01654003 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2012)
  • 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 ]
    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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first. ]
  • Mortality [ Time Frame: From randomization up to 28 days ]
  • SOFA score measurement [ Time Frame: From randomization : day 1, day 2, day 3 ]
  • Death [ Time Frame: 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 [ Time Frame: From randomization up to 28 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Early Goal-directed Fluid Therapy in Septic Patients Undergoing Emergency Surgery
Official Title  ICMJE Impact of Early Goal-directed Fluid Therapy in Septic Patients Undergoing Emergency Surgery. A Prospective, Randomised, Open Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Severe Sepsis
  • Emergency
  • Surgery
Intervention  ICMJE
  • Other: 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.
    Other Names:
    • standard care
    • fluide therapy
    • vasopressor
    • sepsis
  • Other: OPTIMIZED
    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).
    Other Names:
    • GDT fluide therapy
    • Picco
Study Arms  ICMJE
  • 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.

    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.

    Intervention: Other: CONTROL
  • 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).

    Intervention: Other: OPTIMIZED
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 11, 2016)
20
Original Estimated Enrollment  ICMJE
 (submitted: July 27, 2012)
250
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01654003
Other Study ID Numbers  ICMJE NAC 09-044 B
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pavlovic Gordana, MD, University Hospital, Geneva
Study Sponsor  ICMJE University Hospital, Geneva
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Geneva
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP