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
  Purpose

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.


Condition Intervention Phase
Burns
Shock
Device: LIDCO Lithium Dilution Cardiac Output
Other: Standard Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: An Optimizing of the Resuscitative Patterns by Use of Balanced Crystalloids and Colloids and the Non-Invasive Hemodynamic Monitoring

Resource links provided by NLM:


Further study details as provided by Faculty Hospital Kralovske Vinohrady:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: June 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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/
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.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00914563

Locations
Czech Republic
Faculty Hospital Kralovske Vinohrady
Prague, Czech Republic, 10034
Sponsors and Collaborators
Faculty Hospital Kralovske Vinohrady
  More Information

Additional Information:
Publications:

Responsible Party: Faculty Hospital Kralovske Vinohrady
ClinicalTrials.gov Identifier: NCT00914563     History of Changes
Other Study ID Numbers: FH Kralovske Vinohrady
Study First Received: May 28, 2009
Last Updated: June 4, 2009
Health Authority: Czech Republic: Ethics Committee
Czech Republic: Ministry of Health Service by Czech Republic

Keywords provided by Faculty Hospital Kralovske Vinohrady:
Burned shock
Volume resuscitative patterns
Non-invasive hemodynamic monitoring

Additional relevant MeSH terms:
Burns
Shock
Wounds and Injuries
Pathologic Processes
Lithium
Lithium Carbonate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antimanic Agents
Antidepressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014