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

NCT00914563 | Unknown Phase 2

• 1 other identifier: FH Kralovske Vinohrady
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns; Shock

Keywords

Burned shock; Volume resuscitative patterns; Non-invasive hemodynamic monitoring

Outcome Measures

Primary Outcomes (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.

  2009-2010

Secondary Outcomes (1)

• The days of invasive ventilatory support, length of ICU stay, ICU survival, total length of hospital stay and hospital survival.

  2009-2010

Study Arms (2)

LIDCO

EXPERIMENTAL

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

Standard care

NO INTERVENTION

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

Interventions

LIDCO Lithium Dilution Cardiac Output DEVICE

Lithium Dilution Cardiac Output (LIDCO) Plus permits through analysis of the arterial blood pressure trace to acquire items about CO, SVR and DO2.

Also known as: http://www.lidco-ir.co.uk/

LIDCO

Standard Care OTHER

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.

Also known as: Brooke or Parkland formulas

Standard care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• extensively burnt patients (age range 18-75 years) with second and third degree burns
• with TBSA above 15%
• with or without inhalation injury

You may not qualify if:

• with surgically insoluble extent of burns
• dialyzed patients will be excluded

Sponsors & Collaborators

• Faculty Hospital Kralovske Vinohrady: lead

Study Sites (1)

Faculty Hospital Kralovske Vinohrady

Prague, 10034, Czechia

Location

Related Publications (9)

• 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.

  PMID: 12142578 BACKGROUND

• 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.

  PMID: 10752748 BACKGROUND

• 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.

  PMID: 10780609 BACKGROUND

• 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.

  PMID: 15555792 BACKGROUND

• 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.

  PMID: 15953681 BACKGROUND

• 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.

  PMID: 15062415 BACKGROUND

• 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.

  PMID: 16483293 RESULT

• 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.

  PMID: 17019126 RESULT

• 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.

  PMID: 15103422 RESULT

MeSH Terms

Conditions

Burns; Shock

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: May 28, 2009
• First Posted: June 5, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 5, 2009

Record last verified: 2009-06

Locations

CZ (1)