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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)

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ClinicalTrials.gov Identifier: NCT00914563
Recruitment Status : Unknown
Verified June 2009 by Faculty Hospital Kralovske Vinohrady.
Recruitment status was:  Enrolling by invitation
First Posted : June 5, 2009
Last Update Posted : June 5, 2009
Sponsor:
Information provided by:
Faculty Hospital Kralovske Vinohrady

Brief Summary:

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 or disease Intervention/treatment Phase
Burns Shock Device: LIDCO Lithium Dilution Cardiac Output Other: Standard Care Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: An Optimizing of the Resuscitative Patterns by Use of Balanced Crystalloids and Colloids and the Non-Invasive Hemodynamic Monitoring
Study Start Date : June 2009
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns Shock
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. The days of invasive ventilatory support, length of ICU stay, ICU survival, total length of hospital stay and hospital survival. [ Time Frame: 2009-2010 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00914563


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

Additional Information:
Publications:

Responsible Party: Faculty Hospital Kralovske Vinohrady
ClinicalTrials.gov Identifier: NCT00914563     History of Changes
Other Study ID Numbers: FH Kralovske Vinohrady
First Posted: June 5, 2009    Key Record Dates
Last Update Posted: June 5, 2009
Last Verified: June 2009

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

Additional relevant MeSH terms:
Shock
Pathologic Processes
Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs