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

NCT ID: NCT00914563

Last Updated: 2009-06-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-12-31

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.

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.

Conditions

Burns; Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

LIDCO Lithium Dilution Cardiac Output

Intervention Type: DEVICE

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

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.

Group Type: NO_INTERVENTION

Standard Care

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

http://www.lidco-ir.co.uk/; Brooke or Parkland formulas

Eligibility 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Faculty Hospital Kralovske Vinohrady

OTHER_GOV

Sponsor Role: lead

Responsible Party

Faculty Hospital Kralovske Vinohrady

Locations

Faculty Hospital Kralovske Vinohrady

Prague, , Czechia

Countries

Czechia

References

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.

Reference Type: BACKGROUND

PMID: 12142578 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10752748 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10780609 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15555792 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15953681 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15062415 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16483293 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17019126 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15103422 (View on PubMed)

Other Identifiers

FH Kralovske Vinohrady

Identifier Type: -

Identifier Source: org_study_id