FACT in BURNS: 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 Details
Study Description
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 |
|---|---|---|
|
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 Design
Arms and Interventions
| 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 Names:
|
| 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 Names:
|
Outcome Measures
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. [2009-2010]
Secondary Outcome Measures
- The days of invasive ventilatory support, length of ICU stay, ICU survival, total length of hospital stay and hospital survival. [2009-2010]
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Faculty Hospital Kralovske Vinohrady | Prague | Czech Republic | 10034 |
Sponsors and Collaborators
- Faculty Hospital Kralovske Vinohrady
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Ahrns KS. Trends in burn resuscitation: shifting the focus from fluids to adequate endpoint monitoring, edema control, and adjuvant therapies. Crit Care Nurs Clin North Am. 2004 Mar;16(1):75-98. Review.
- Cartotto RC, Innes M, Musgrave MA, Gomez M, Cooper AB. How well does the Parkland formula estimate actual fluid resuscitation volumes? J Burn Care Rehabil. 2002 Jul-Aug;23(4):258-65.
- Holm C, Mayr M, Tegeler J, Hörbrand F, Henckel von Donnersmarck G, Mühlbauer W, Pfeiffer UJ. A clinical randomized study on the effects of invasive monitoring on burn shock resuscitation. Burns. 2004 Dec;30(8):798-807.
- Holm C, Melcer B, Hörbrand F, von Donnersmarck GH, Mühlbauer W. The relationship between oxygen delivery and oxygen consumption during fluid resuscitation of burn-related shock. J Burn Care Rehabil. 2000 Mar-Apr;21(2):147-54.
- Holm C, Melcer B, Hörbrand F, Wörl H, von Donnersmarck GH, Mühlbauer W. Intrathoracic blood volume as an end point in resuscitation of the severely burned: an observational study of 24 patients. J Trauma. 2000 Apr;48(4):728-34.
- Huang Y, Yan B, Yang Z. Clinical study of a formula for delayed rapid fluid resuscitation for patients with burn shock. Burns. 2005 Aug;31(5):617-22.
- FH Kralovske Vinohrady