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

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

Tracking Information

• First Submitted Date: July 18, 2012
• First Posted Date: July 31, 2012
• Last Update Posted Date: May 13, 2016
• Study Start Date: April 2010
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: Complete list of historical versions of study NCT01654003 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Severe Sepsis
• Emergency
• Surgery

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: May 11, 2016): 20
• Original Estimated Enrollment (submitted: July 27, 2012): 250
• Actual Study Completion Date: December 2014
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT01654003
• Other Study ID Numbers: NAC 09-044 B
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pavlovic Gordana, MD, University Hospital, Geneva
• Study Sponsor: University Hospital, Geneva
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University Hospital, Geneva
• Verification Date: May 2016