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

This study is currently recruiting participants.
Verified August 2012 by University Hospital, Geneva
Sponsor:
Information provided by (Responsible Party):
Pavlovic Gordana, MD, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01653977
First received: July 18, 2012
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

This study compares the safety and efficacy of GDTs using standard pressure-related parameters vs. dynamic hemodynamic indices associated with fluid compartment monitoring, in trauma patients requiring emergency surgery.


Condition Intervention
Hypovolemic Shock
Trauma
Emergency
Surgery
Other: CONTROL
Other: OPTIMIZED

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Impact of Early Goal-directed Fluid Therapy in Hypovolemic Patients Undergoing Emergency Surgery A Prospective, Randomised, Open Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: From randomization up to 28 days ] [ Designated as safety issue: No ]
  • SOFA score measurement [ Time Frame: From randomization : day 1, day 2, day 3 ] [ Designated as safety issue: No ]
  • Death [ Time Frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first. ] [ Designated as safety issue: No ]
  • Number of unexpected ICU admission [ Time Frame: From randomization up to 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: February 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
  • trauma
  • fluide balance
  • Vasopressors
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).

Other: 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).

Other Names:
  • Goal-directed therapy
  • Picco
  • Fluide balance optimized
  • Vasopressor
  • CI

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01653977

Contacts
Contact: Gordana Pavlovic, MD +41 22 79 55 32098 Gordana.Pavlovic@hcuge.ch
Contact: Marc-Joseph Licker, Professor +41 79 55 32111 Marc-Joseph.Licker@hcuge.ch

Locations
Switzerland
Hôpitaux universitaires de Genève Recruiting
Genève, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Gordana Pavlovic, MD Hôpitaux universitaires de Genève
  More Information

No publications provided

Responsible Party: Pavlovic Gordana, MD, Principal Investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01653977     History of Changes
Other Study ID Numbers: NAC 09-044
Study First Received: July 18, 2012
Last Updated: August 6, 2012
Health Authority: Switzerland: Swiss Medic

Keywords provided by University Hospital, Geneva:
Hypovolemic shock
trauma
emergency
surgery
GDT
Picco

Additional relevant MeSH terms:
Emergencies
Shock
Hypovolemia
Disease Attributes
Pathologic Processes
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014