BurnsPhase 2FACT in BURNSNCT00914563
An Upgrading of the Resuscitative Patterns by Utilization of the Balanced Crystalloids and Synthetic Colloids and the Non-Invasive Hemodynamic Monitoring During Burn Shock
A Phase 2 study testing LIDCO Lithium Dilution Cardiac Output in people with Burns and Shock, run by Faculty Hospital Kralovske Vinohrady at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- LIDCO Lithium Dilution Cardiac Output
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCzechia
- Study dates
- Jun 2009to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- extensively burnt patients (age range 18-75 years) with second and third degree burns
- with TBSA above 15%
- with or without inhalation injury
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- LIDCO Lithium Dilution Cardiac Output, Standard Care
- Keywords
- Burned shock, Volume resuscitative patterns, Non-invasive hemodynamic monitoring
- Medical subject headings
- Burns, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIDCO Lithium Dilution Cardiac OutputDevice
Also called http://www.lidco-ir.co.uk/
Lithium Dilution Cardiac Output (LIDCO) Plus permits through analysis of the arterial blood pressure trace to acquire items about CO, SVR and DO2.
Standard CareOther
Also called Brooke or Parkland formulas
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2009-2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculty Hospital Kralovske Vinohrady
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914563
- Sponsor's protocol ID
- FH Kralovske Vinohrady
- Acronym
- FACT in BURNS
- Status last verified
- Jun 2009
- First submitted
- 28 May 2009
- Last updated
- 5 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 12142578Holm 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.
PubMed 10752748Holm 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.
PubMed 10780609Holm 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.
PubMed 15555792Huang 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.
PubMed 15953681Ahrns 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.
PubMed 15062415Mitra 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.
PubMed 16483293Berger 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.
PubMed 17019126Czermak 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.
PubMed 15103422
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Optimizing of the Resuscitative Patterns by Use of Balanced Crystalloids and Colloids and the Non-Invasive Hemodynamic Monitoring
- ClinicalTrials.gov ID
- NCT00914563
- Acronym / sponsor ID
- FACT in BURNS / FH Kralovske Vinohrady
- Keywords
- Burned shock, Volume resuscitative patterns, Non-invasive hemodynamic monitoring
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Faculty Hospital Kralovske VinohradyOther government
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 5 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LIDCO | Experimental | Device: LIDCO Lithium Dilution Cardiac OutputThe 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. |
| Standard care | No intervention | Other: Standard CareWe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- extensively burnt patients (age range 18-75 years) with second and third degree burns
- with TBSA above 15%
- with or without inhalation injury
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIDCO Lithium Dilution Cardiac OutputAlso: http://www.lidco-ir.co.uk/Lithium Dilution Cardiac Output (LIDCO) Plus permits through analysis of the arterial blood pressure trace to acquire items about CO, SVR and DO2. | Device | LIDCO |
| Standard CareAlso: Brooke or Parkland formulasWe 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 |
Primary outcome
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.
Time frame: 2009-2010
1 secondary outcome
The days of invasive ventilatory support, length of ICU stay, ICU survival, total length of hospital stay and hospital survival.
Time frame: 2009-2010
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2009.
- Background: PubMed 12142578Cartotto 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.
- Background: PubMed 10752748Holm 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.
- Background: PubMed 10780609Holm 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.
- Background: PubMed 15555792Holm 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.
- Background: PubMed 15953681Huang 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.
- Background: PubMed 15062415Ahrns 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.
- Results publication: PubMed 16483293Mitra 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.
- Results publication: PubMed 17019126Berger 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.
- Results publication: PubMed 15103422Czermak 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.
- Related InfoLink provided by the sponsor.
Related trials for Burns
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruiting
Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children
Burn Injury, Procedural Anxiety
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
RecruitingPhase 2
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Pruritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LIDCO Lithium Dilution Cardiac Output in people with Burns and Shock, run by Faculty Hospital Kralovske Vinohrady at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 2009-2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00914563, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2009.