An Upgrading of the Resuscitative Patterns by Utilization of the Balanced Crystalloids and Synthetic Colloids and the Non-Invasive Hemodynamic Monitoring During Burn Shock (FACT in BURNS)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Faculty Hospital Kralovske Vinohrady
ClinicalTrials.gov Identifier:
NCT00914563
First received: May 28, 2009
Last updated: June 4, 2009
Last verified: June 2009

May 28, 2009
June 4, 2009
June 2009
June 2010   (final data collection date for primary outcome measure)
The total fluid balance at day 1, 2 and cumulative fluid balance at day 7, reversal of organ dysfunction according to SOFA score at day 3 and 7 in both groups. [ Time Frame: 2009-2010 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00914563 on ClinicalTrials.gov Archive Site
The days of invasive ventilatory support, length of ICU stay, ICU survival, total length of hospital stay and hospital survival. [ Time Frame: 2009-2010 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
An Upgrading of the Resuscitative Patterns by Utilization of the Balanced Crystalloids and Synthetic Colloids and the Non-Invasive Hemodynamic Monitoring During Burn Shock
An Optimizing of the Resuscitative Patterns by Use of Balanced Crystalloids and Colloids and the Non-Invasive Hemodynamic Monitoring

Fluid Therapy Lithium Dilution Cardiac Output (LIDCO) controlled trial in BURNS (FACT in BURNS) is a prospective randomized multicentric study.

Introduction: The goal of this trial is the verification, optional upgrading and optimizing of the resuscitative patterns in light of the new generation of balanced crystalloids and colloids and, by utilization the non-invasive hemodynamic monitoring LIDCO.

Methods: The extensively burnt patients (age range 18-75 years) with second and the third degree burns, with TBSA above 15%, with or without inhalation injury will be included to the study within 2009-2010. The patients meeting inclusion criteria but with an adverse critical prognosis from the beginning of the hospitalization, with surgically insoluble extent of burns or the dialyzed patients will be excluded.The patients will be routinely monitored. We will use the continuous real-time hemodynamic monitoring through transpulmonal lithium dilution additionally. The monitor Lithium Dilution Cardiac Output (LIDCO) Plus permits through analysis of the arterial blood pressure trace to acquire items about CO, SVR and DO2 . In fluid resuscitation, we will use a combination of the balanced crystalloids and synthetic colloids (of the middle molecular weight) in the ratio 2 ml/kg/% TBSA : 1 ml/kg/% TBSA. The control group will be composed of the patients supervised in a standard way, volume resuscitated according to the Brooke or Parkland formulas. MAP > 65 torr, urine output 0,5 ml/kg/h, CI 2,5 - 4,0 l/min/m2, DO2I 500 - 600 ml/min/m2 are the goals.We will measure the levels of proANP (pro Natriuretic peptide) and Angiotensin Converting Enzyme (ACE) at artificial ventilated patients. The plasma ACE and proANP concentrations were measured by commercially available ELISA immunoassays.

Conclusions: We will evaluate the total fluid balance at day 1, 2 and cumulative fluid balance at day 7, reversal of organ dysfunction according to SOFA score at day 3 and 7 in both group. The days of invasive ventilatory support, length of ICU stay, ICU survival, total length of hospital stay and hospital survival are the additional endpoints.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Burns
  • Shock
  • Device: LIDCO Lithium Dilution Cardiac Output
    Lithium Dilution Cardiac Output (LIDCO) Plus permits through analysis of the arterial blood pressure trace to acquire items about CO, SVR and DO2.
    Other Name: http://www.lidco-ir.co.uk/
  • Other: Standard Care
    We will compare the standard monitored and volume resuscitated group of patients with the LIDCO monitored group. The control group will be composed of the patients supervised in a standard way, volume resuscitated according to the Brooke or Parkland formulas.
    Other Name: Brooke or Parkland formulas
  • Experimental: LIDCO
    The extensively burnt patients (age range 18-75 years) with second and the third degree burns, with TBSA above 15%, with or without inhalation injury will be included to the study. We will compare the standard monitored and volume resuscitated group of patients with the LIDCO monitored group. We will use in the LIDCO group the continuous real-time hemodynamic monitoring through transpulmonal lithium dilution additionally. The monitor Lithium Dilution Cardiac Output (LIDCO) Plus permits, through analysis of the arterial blood pressure trace, to acquire items about CO, SVR and DO2. In fluid resuscitation, we will use a combination of the balanced crystalloids and synthetic colloids (of the middle molecular weight) in the ratio 2 ml/kg/% TBSA: 1 ml/kg/% TBSA.
    Intervention: Device: LIDCO Lithium Dilution Cardiac Output
  • No Intervention: Standard care
    We will compare the standard monitored and volume resuscitated group of patients with the LIDCO monitored group. The control group will be composed of the patients supervised in a standard way, volume resuscitated according to the Brooke or Parkland formulas.
    Intervention: Other: Standard Care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
20
December 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • extensively burnt patients (age range 18-75 years) with second and third degree burns
  • with TBSA above 15%
  • with or without inhalation injury

Exclusion Criteria:

  • patients meeting inclusion criteria but with an adverse critical prognosis from the beginning of hospitalization
  • with surgically insoluble extent of burns
  • dialyzed patients will be excluded
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
NCT00914563
FH Kralovske Vinohrady
No
Faculty Hospital Kralovske Vinohrady
Faculty Hospital Kralovske Vinohrady
Not Provided
Not Provided
Faculty Hospital Kralovske Vinohrady
June 2009

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