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)

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.

Study Overview

• Status: Unknown
• Conditions: Burns; Shock
• Intervention / Treatment: Device: LIDCO Lithium Dilution Cardiac Output; Other: Standard Care

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
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Czech Republic
  • Prague, Czech Republic, 10034
    • Faculty Hospital Královské Vinohrady

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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: 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 Names: Brooke or Parkland formulas

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Faculty Hospital Kralovske Vinohrady

Publications and helpful links

General Publications

• 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. doi: 10.1097/00004630-200207000-00006.
• Holm C, Melcer B, Horbrand F, von Donnersmarck GH, Muhlbauer 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. doi: 10.1097/00004630-200021020-00011.
• Holm C, Melcer B, Horbrand F, Worl H, von Donnersmarck GH, Muhlbauer 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. doi: 10.1097/00005373-200004000-00023.
• Holm C, Mayr M, Tegeler J, Horbrand F, Henckel von Donnersmarck G, Muhlbauer W, Pfeiffer UJ. A clinical randomized study on the effects of invasive monitoring on burn shock resuscitation. Burns. 2004 Dec;30(8):798-807. doi: 10.1016/j.burns.2004.06.016.
• 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. doi: 10.1016/j.burns.2005.02.002.
• 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. doi: 10.1016/j.ccell.2003.09.007.
• Mitra B, Fitzgerald M, Cameron P, Cleland H. Fluid resuscitation in major burns. ANZ J Surg. 2006 Jan-Feb;76(1-2):35-8. doi: 10.1111/j.1445-2197.2006.03641.x.
• Berger MM, Bernath MA, Chiolero RL. Resuscitation, anaesthesia and analgesia of the burned patient. Curr Opin Anaesthesiol. 2001 Aug;14(4):431-5. doi: 10.1097/00001503-200108000-00009.
• Czermak C, Hartmann B, Scheele S, Germann G, Kuntscher MV. [Burn shock fluid resuscitation and hemodynamic monitoring]. Chirurg. 2004 Jun;75(6):599-604. doi: 10.1007/s00104-004-0859-z. German.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Anticipated): June 1, 2010
• Study Completion (Anticipated): December 1, 2010

Study Registration Dates

• First Submitted: May 28, 2009
• First Submitted That Met QC Criteria: June 4, 2009
• First Posted (Estimate): June 5, 2009

Study Record Updates

• Last Update Posted (Estimate): June 5, 2009
• Last Update Submitted That Met QC Criteria: June 4, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: Burned shock; Volume resuscitative patterns; Non-invasive hemodynamic monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Shock; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Antimanic Agents; Lithium Carbonate
• Other Study ID Numbers: FH Kralovske Vinohrady