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| Tracking Information | |||||||||
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| First Received Date ICMJE | May 15, 2006 | ||||||||
| Last Updated Date | June 15, 2006 | ||||||||
| Start Date ICMJE | May 2006 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00326729 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Fluid Shifts During Resuscitation: Impacts on Macrocirculation and Microcirculation | ||||||||
| Official Title ICMJE | |||||||||
| Brief 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. 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:
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:
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.
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. |
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| Detailed Description | |||||||||
| Study Phase | Phase IV | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Screening, Cross-Sectional, Defined Population, Prospective Study | ||||||||
| Condition ICMJE | Burns | ||||||||
| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 40 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00326729 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | HD06-004 | ||||||||
| Study Sponsor ICMJE | Montreal Burn Centre | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Montreal Burn Centre | ||||||||
| Verification Date | May 2006 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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