BurnsNCT00326729
Fluid Shifts During Resuscitation: Impacts on Macrocirculation and Microcirculation
An observational study of Burns, run by Montreal Burn Centre at 1 site in Canada.
Trial summary
Fluid resuscitation in burn patients is associated with major macrocirculatory and microcirculatory disturbances that have been poorly described. When done according to expert opinions, it is now rare to encounter the death of a patient due to an inadequate fluid resuscitation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Burns
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- May 2006to not given
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major thermal, electrical, or chemical burns
- Admission to the burn unit within 6 hours after burn
- Burned surface area over 20% or equivalent
- Signed consent by the patient or relative
- Commitment to full maximal support
Who cannot join
- Patient under 18 years old
- Patient over 80 years old
- Pregnancy
- Chronic renal failure requiring dialysis
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2W1T8
Patrice Deroy, 514-890-8000 ext. 15066, patrice.deroy.chum@ssss.gouv.qc.ca
David Bracco, MD
About this study
Fluid resuscitation in burn patients is associated with major macrocirculatory and microcirculatory disturbances that have been poorly described. When done according to expert opinions, it is now rare to encounter the death of a patient due to an inadequate fluid resuscitation. Fluid resuscitation in burn patients is more opinion-based than evidence-based. Although burn admission to an intensive care facility is relatively rare, the burn patient is well suited to answer questions in the fluid resuscitation field because, as opposed to other critically ill patients:
- investigators do have a time 'zero' for burn patients; they know exactly when the insult occurred;
- apart from fluid resuscitation, the management of burn patients is uniform in the investigators' unit and is done according to various protocols;
- the burn population is more uniform than the septic population making confounders and background noises less likely; and
- as basic as it might sound, studying fluid resuscitation implies accomplishing a significant one; burn patients are the category of critically ill patients receiving the most important fluid resuscitation.
Read more
Studies that have addressed the question of fluid resuscitation in burn patients are quite numerous. However, they are either under-powered, dealing with various interventions or outcomes and sometimes of poor methodological quality.
Moving the investigators' focus from macrohemodynamic to microhemodynamic monitoring is now essential and due to recent technological advances, severe impairments in microcirculatory perfusion are now being recognized in various pathological states. What is now clear from various studies is the fact that even with restoring 'normal' macrocirculatory parameters, severe microcirculatory alterations can be seen.
This study is an integral part of a program aimed to explore different questions regarding fluid resuscitation in burn patients. The aim is to characterize changes in fluid shift, fluid accumulation, and vascular volumes after burn injury and also to study the effects of an artificial colloid on different macrocirculatory and microcirculatory parameters. The primary end points are:
- fluid accumulation during the initial phase; and
- short term effects of colloids on macrocirculatory and microcirculatory parameters.
This study will collect data on macro- and microcirculation derived from current monitoring systems. Data (see below) will be collected at defined time points and before and after the first two fluid challenges. If the fluid challenge occurs in a one hour time frame of a defined time point, only one assessment will be done.
- At defined time points: a set of data (see below) will be collected by the research team at baseline, 6, 12, 18, 24, 36, 48 and 72 hours after burn injury. Baseline values will be the ones obtained immediately after consent.
- Fluid challenges: Burn patients often require additional fluid bolus to maintain hemodynamic stability because of the following reasons: hypotension; decreased urine output (less than 0.5 ml/kg/hour); uncorrected metabolic acidosis; rhabdomyolysis; increasing hematocrit; or any other clinical reason according to the attending physician.
In this study, the two first fluid challenges will be allocated according to a random list. One bolus will be Pentaspan (500 ml) and the other will be a crystalloid solution (Ringer's lactate 1000 ml). These two alternatives represent a true equipoise as they are equally acceptable because choosing one of them depends on the preference of the attending physician. Fluid challenges will be allocated using a randomised short block cross-over sequence.
The following parameters will be measured at a fixed time and before and after the fluid challenges using different techniques.
Parameters:
Intrathoracic blood volume, extravascular lung water, total blood volume; extracellular edema; intraventricular preload, ventricular volumes, diastolic function; cardiac output; mixed venous saturation; oncotic pressure; microcirculatory assessment: number and diameter of capillaries, proportion of perfusion, and flow velocities.
This is an observational, one-group study aimed at describing macrocirculation and microcirculation parameters in a burn patient population. The investigators arbitrarily plan to enroll 40 patients.
- Conditions
- Burns
- Keywords
- burns, thermal injury, hemodynamics, microcirculation
- Medical subject headings
- Burns
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2006 (estimated)
- Study startMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Montreal Burn Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Canadian Anesthesiologists' Society
- Investigators
- David Bracco, MD, Principal investigator, Centre Hospitalier de l'Universite de MontrealMarc-Jacques Dubois, MD, Principal investigator, Centre Hospitalier de l'Universite de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00326729
- Sponsor's protocol ID
- HD06-004
- Status last verified
- May 2006
- First submitted
- 15 May 2006
- Last updated
- 16 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Shifts During Resuscitation: Impacts on Macrocirculation and Microcirculation
- ClinicalTrials.gov ID
- NCT00326729
- Acronym / sponsor ID
- HD06-004
- Conditions
- Burns
- Keywords
- burns, thermal injury, hemodynamics, microcirculation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- Montreal Burn CentreUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Canadian Anesthesiologists' Society
- Study start
- May 2006
- First posted
- 17 May 2006 (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 resuscitation in burn patients is associated with major macrocirculatory and microcirculatory disturbances that have been poorly described. When done according to expert opinions, it is now rare to encounter the death of a patient due to an inadequate fluid resuscitation. Fluid resuscitation in burn patients is more opinion-based than evidence-based. Although burn admission to an intensive care facility is relatively rare, the burn patient is well suited to answer questions in the fluid resuscitation field because, as opposed to other critically ill patients:
- investigators do have a time 'zero' for burn patients; they know exactly when the insult occurred;
- apart from fluid resuscitation, the management of burn patients is uniform in the investigators' unit and is done according to various protocols;
- the burn population is more uniform than the septic population making confounders and background noises less likely; and
- as basic as it might sound, studying fluid resuscitation implies accomplishing a significant one; burn patients are the category of critically ill patients receiving the most important fluid resuscitation.
Studies that have addressed the question of fluid resuscitation in burn patients are quite numerous. However, they are either under-powered, dealing with various interventions or outcomes and sometimes of poor methodological quality.
Moving the investigators' focus from macrohemodynamic to microhemodynamic monitoring is now essential and due to recent technological advances, severe impairments in microcirculatory perfusion are now being recognized in various pathological states. What is now clear from various studies is the fact that even with restoring 'normal' macrocirculatory parameters, severe microcirculatory alterations can be seen.
This study is an integral part of a program aimed to explore different questions regarding fluid resuscitation in burn patients. The aim is to characterize changes in fluid shift, fluid accumulation, and vascular volumes after burn injury and also to study the effects of an artificial colloid on different macrocirculatory and microcirculatory parameters. The primary end points are:
- fluid accumulation during the initial phase; and
- short term effects of colloids on macrocirculatory and microcirculatory parameters.
This study will collect data on macro- and microcirculation derived from current monitoring systems. Data (see below) will be collected at defined time points and before and after the first two fluid challenges. If the fluid challenge occurs in a one hour time frame of a defined time point, only one assessment will be done.
- At defined time points: a set of data (see below) will be collected by the research team at baseline, 6, 12, 18, 24, 36, 48 and 72 hours after burn injury. Baseline values will be the ones obtained immediately after consent.
- Fluid challenges: Burn patients often require additional fluid bolus to maintain hemodynamic stability because of the following reasons: hypotension; decreased urine output (less than 0.5 ml/kg/hour); uncorrected metabolic acidosis; rhabdomyolysis; increasing hematocrit; or any other clinical reason according to the attending physician.
In this study, the two first fluid challenges will be allocated according to a random list. One bolus will be Pentaspan (500 ml) and the other will be a crystalloid solution (Ringer's lactate 1000 ml). These two alternatives represent a true equipoise as they are equally acceptable because choosing one of them depends on the preference of the attending physician. Fluid challenges will be allocated using a randomised short block cross-over sequence.
The following parameters will be measured at a fixed time and before and after the fluid challenges using different techniques.
Parameters:
Intrathoracic blood volume, extravascular lung water, total blood volume; extracellular edema; intraventricular preload, ventricular volumes, diastolic function; cardiac output; mixed venous saturation; oncotic pressure; microcirculatory assessment: number and diameter of capillaries, proportion of perfusion, and flow velocities.
This is an observational, one-group study aimed at describing macrocirculation and microcirculation parameters in a burn patient population. The investigators arbitrarily plan to enroll 40 patients.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Major thermal, electrical, or chemical burns
- Admission to the burn unit within 6 hours after burn
- Burned surface area over 20% or equivalent
- Signed consent by the patient or relative
- Commitment to full maximal support
Key exclusion criteria (4 listed)
- Patient under 18 years old
- Patient over 80 years old
- Pregnancy
- Chronic renal failure requiring dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2006.
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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.
David Bracco, MD principal investigator
Centre Hospitalier de l'Universite de Montreal
Marc-Jacques Dubois, MD principal investigator
Centre Hospitalier de l'Universite de Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burns, run by Montreal Burn Centre at 1 site in Canada.
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 5 inclusion and 4 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 16 Jun 2006. 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 Canada. 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.
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?
Contact Patrice Deroy (514-890-8000 ext. 15066, patrice.deroy.chum@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 16 Jun 2006.