Fluid Shifts During Resuscitation: Impacts on Macrocirculation and Microcirculation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00326729|
Recruitment Status : Unknown
Verified May 2006 by Montreal Burn Centre.
Recruitment status was: Recruiting
First Posted : May 17, 2006
Last Update Posted : June 16, 2006
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.
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.
|Condition or disease||Phase|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Observational Model:||Defined Population|
|Study Start Date :||May 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00326729
|Contact: Patrice Deroy||514-890-8000 ext email@example.com|
|Centre Hospitalier de l'Universite de Montreal||Recruiting|
|Montreal, Quebec, Canada, H2W1T8|
|Contact: Patrice Deroy 514-890-8000 ext 15066 firstname.lastname@example.org|
|Principal Investigator: David Bracco, MD|
|Sub-Investigator: Marc-Jacques Dubois, MD|
|Sub-Investigator: Emmanuel Sirdar, MD|
|Sub-Investigator: Louise Duranceau, MD|
|Principal Investigator:||David Bracco, MD||Centre Hospitalier de l'Universite de Montreal|
|Principal Investigator:||Marc-Jacques Dubois, MD||Centre Hospitalier de l'Universite de Montreal|