Ignite Creation Date:
2024-05-05 @ 9:30 PM
Last Modification Date:
2024-10-26 @ 10:04 AM
Study NCT ID:
NCT00890383
Status:
COMPLETED
Last Update Posted:
2009-11-25
First Post:
2009-04-28
Brief Title:
Colloids in Severe Trauma
Sponsor:
University of the Philippines
Organization:
University of the Philippines
Study Overview
Official Title:
Colloids in Severe Trauma A Multi-Center Pilot Study of Crystalloid Only or Crystalloid Colloid Volume Resuscitation in Trauma Patients CIST
Status:
COMPLETED
Status Verified Date:
2009-11
Last Known Status:
None
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:
CIST
Brief Summary:
Background
Fluid resuscitation is a cornerstone of the initial management of the critically injured trauma patient yet there are numerous controversies surrounding this very common practice As a result these controversies have been the subject of numerous clinical trials evidence-based guidelines and systematic reviews
With the publication of the landmark SAFE Study the equipoise between the 2 treatments which were representative solutions for colloid and crystalloids respectively 4 albumin and saline was established This has however been brought into further doubt by the paucity of data on the use of hydroxyethylstarches HES which are less costly and have less side effects than albumin in trauma More recent findings by Gruen and colleagues have shown that as much as 5 of all trauma deaths are the result of fluid overload based on the North American fluid management model for trauma pure crystalloid fluid management
A meta-analysis done by Kern and Shoemaker found that supranormal fluid resuscitation with crystalloids is beneficial when given before the onset of organ failure in critically ill surgical patients Balogh and colleagues found out that when supranormal fuid resuscitation with crystalloids was applied to victims of severe trauma this resulted in a statistically significant increase in the incidence of mortality multiple organ failure intra-abdominal hypertension IAH and abdominal compartment syndrome ACS More recently Kirkpatrick and colleagues reviewed and defined a secondary ACS as a direct result of fluid resuscitation They concluded that excess resuscitation with crystalloid fluids might be harming patients and contributing to an increased occurrence of ACS
This study will serve as a pilot to test the hypothesis that there will be significant differences in clinical outcomes for patients with severe trauma treated with colloid HES plus crystalloid and crystalloid only fluid management regimens most notably the incidence of IAH and ACS
It is hoped that the hybrid colloid HES plus crystalloid fluid management regimen will provide a means to avoid the untoward fluid overload andor other complications of pure crystalloid fluid management and the costscomplications of albumin administration
Fluid resuscitation is a cornerstone of the initial management of the critically injured trauma patient yet there are numerous controversies surrounding this very common practice As a result these controversies have been the subject of numerous clinical trials evidence-based guidelines and systematic reviews
With the publication of the landmark SAFE Study the equipoise between the 2 treatments which were representative solutions for colloid and crystalloids respectively 4 albumin and saline was established This has however been brought into further doubt by the paucity of data on the use of hydroxyethylstarches HES which are less costly and have less side effects than albumin in trauma More recent findings by Gruen and colleagues have shown that as much as 5 of all trauma deaths are the result of fluid overload based on the North American fluid management model for trauma pure crystalloid fluid management
A meta-analysis done by Kern and Shoemaker found that supranormal fluid resuscitation with crystalloids is beneficial when given before the onset of organ failure in critically ill surgical patients Balogh and colleagues found out that when supranormal fuid resuscitation with crystalloids was applied to victims of severe trauma this resulted in a statistically significant increase in the incidence of mortality multiple organ failure intra-abdominal hypertension IAH and abdominal compartment syndrome ACS More recently Kirkpatrick and colleagues reviewed and defined a secondary ACS as a direct result of fluid resuscitation They concluded that excess resuscitation with crystalloid fluids might be harming patients and contributing to an increased occurrence of ACS
This study will serve as a pilot to test the hypothesis that there will be significant differences in clinical outcomes for patients with severe trauma treated with colloid HES plus crystalloid and crystalloid only fluid management regimens most notably the incidence of IAH and ACS
It is hoped that the hybrid colloid HES plus crystalloid fluid management regimen will provide a means to avoid the untoward fluid overload andor other complications of pure crystalloid fluid management and the costscomplications of albumin administration
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