Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00326729
Status:
UNKNOWN
Last Update Posted:
2006-06-16
First Post:
2006-05-15
Brief Title:
Fluid Shifts During Resuscitation Impacts on Macrocirculation and Microcirculation
Sponsor:
Montreal Burn Centre
Organization:
Montreal Burn Centre
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2006-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
1 investigators do have a time zero for burn patients they know exactly when the insult occurred
2 apart from fluid resuscitation the management of burn patients is uniform in the investigators unit and is done according to various protocols
3 the burn population is more uniform than the septic population making confounders and background noises less likely and
4 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
1 fluid accumulation during the initial phase and
2 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
1 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
2 Fluid challenges Burn patients often require additional fluid bolus to maintain hemodynamic stability because of the following reasons hypotension decreased urine output less than 05 mlkghour 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 Ringers 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
1 investigators do have a time zero for burn patients they know exactly when the insult occurred
2 apart from fluid resuscitation the management of burn patients is uniform in the investigators unit and is done according to various protocols
3 the burn population is more uniform than the septic population making confounders and background noises less likely and
4 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
1 fluid accumulation during the initial phase and
2 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
1 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
2 Fluid challenges Burn patients often require additional fluid bolus to maintain hemodynamic stability because of the following reasons hypotension decreased urine output less than 05 mlkghour 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 Ringers 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None