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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Optimizing of the Resuscitative Patterns by Use of Balanced Crystalloids and Colloids and the Non-Invasive Hemodynamic Monitoring

Conditions
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Burns, Shock

Intervention / Treatment
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* Device: LIDCO Lithium Dilution Cardiac Output
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LIDCO<br>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<br>* Lithium Dilution Cardiac Output (LIDCO) Plus permits through analysis of the arterial blood pressure trace to acquire items about CO, SVR and DO2.<br>* Other names: http://www.lidco-ir.co.uk/;|
| No Intervention: Standard care<br>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<br>* 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.<br>* Other names: Brooke or Parkland formulas;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 2009-2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The days of invasive ventilatory support, length of ICU stay, ICU survival, total length of hospital stay and hospital survival. |  | 2009-2010 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burned shock, Volume resuscitative patterns, Non-invasive hemodynamic monitoring