Ignite Creation Date:
2024-05-05 @ 11:32 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01355094
Status:
COMPLETED
Last Update Posted:
2023-02-03
First Post:
2011-05-12
Brief Title:
Peritoneal Vacuum Therapy to Reduce Inflammatory Response From Abdominal SepsisInjury
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Peritoneal Vacuum Therapy to Reduce the Systemic Inflammatory Insult From Intraperitoneal SepsisInjuryHypertension A Randomized Comparison of Baseline Wall Suction Versus the KCI AbThera Abdominal Dressing
Status:
COMPLETED
Status Verified Date:
2023-02
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:
SAD
Brief Summary:
This pilot study will evaluate the effectiveness in actively removing the peritoneal fluid through the use of a commercial suction device compared to passive drainage of the same peritoneal fluid drained through standard surgical drains under bulb suction only in critically ill patients who require an open abdomen Both techniques being used the commercial KCI AbThera device and home made Stampede VAC system are currently approved for use in Canada and used in our facility
The use or non-use of the open abdomen and its relationship to intra-abdominal hypertension IAH and the abdominal compartment syndrome ACS the level of IAH must be treated and if so how should be treated - remain controversial The ultimate treatment for IAHACS is to leave the abdominal fascia open after laparotomy utilizing some form of temporary abdominal closure TAC techniques resulting in an open abdomenOA The decision to accept an OA can only be made in the operating room and is typically made quite arbitrarily there is no current standard or protocoland the TAC used is based on the surgeons best judgment The study intends to randomize patients after it has been decided that a TAC is required which will be applied in the operating room while the patient is fully anesthetized The only intervention required is to obtain small aliquots a teaspoonful-15ml of blood for the evaluation of inflammatory mediators levels as well as the same volume of intra-peritoneal fluid-that is typically discarded in patients with OA
The use or non-use of the open abdomen and its relationship to intra-abdominal hypertension IAH and the abdominal compartment syndrome ACS the level of IAH must be treated and if so how should be treated - remain controversial The ultimate treatment for IAHACS is to leave the abdominal fascia open after laparotomy utilizing some form of temporary abdominal closure TAC techniques resulting in an open abdomenOA The decision to accept an OA can only be made in the operating room and is typically made quite arbitrarily there is no current standard or protocoland the TAC used is based on the surgeons best judgment The study intends to randomize patients after it has been decided that a TAC is required which will be applied in the operating room while the patient is fully anesthetized The only intervention required is to obtain small aliquots a teaspoonful-15ml of blood for the evaluation of inflammatory mediators levels as well as the same volume of intra-peritoneal fluid-that is typically discarded in patients with OA
Detailed Description:
Excessive pressure within the peritoneal cavity known as intra-abdominal hypertension IAH can adversely affect not only intra-peritoneal organ function but also other organ systems throughout the body When IAH 20 mmHg induces new organ dysfunction a potentially lethal condition known as the abdominal compartment syndrome ACS is defined Practically this syndrome can be considered multi-system organ failure occurring from severe IAH While the physical effects of IAHACS are increasingly being described the humoral ones related to IAH-induced ischemia are poorly understood Recent animal work suggests that aggressively removing intra-peritoneal fluids assumed to be vasoactive mediator-rich leads to better systemic outcomes There is no human data to support this however Previous attempts at peritoneal drainage in inflammatory conditions such as sepsis and pancreatitis where not conclusive but this may have been due to the inefficiency of the systems used and the lack of attention to IAH Recently efficient systems providing a temporary abdominal closure TAC to both drain intra-peritoneal fluids and to control IAH have been introduced One of these dressing systems known as the KCI AbThera Abdominal Dressing is currently approved for use in Canada as a temporary abdominal closure TAC device but its role in ameliorating systemic sepsisSIRS has not been evaluated
We propose a randomized trial of using either the home Calgary Stampede Vac involving wall suction or the KCI AbThera Abdominal Dressing to dress the abdomen whenever the operative surgeon determines that an open abdomen is warranted to treat the patient
In general others have hypothesized that cytokines especially peritoneal levels are sensitive indicators of the post-operative inflammatory reaction and may predict complications In experimental models IL-6 levels are higher in non-survivors Further previous work has noted that the blood level of IL-6 which has a longer half life than TNF-α or IL-1β is a good index of the overall cytokine cascade activation Thus the main outcomes to be compared will be between mean cytokine levels measured in each of the two treatment groups - to determine if the KCI AbThera Abdominal Dressing can significantly reduce the blood concentration of IL-6 when compared with the Stampede VAC system We are hoping to better understand how the body responds to the inflammatory process that naturally occurs during and after an episode of intra-abdominal hypertension to identify signals or markers of inflammation and infection as well as its progression and outcome
We propose a randomized trial of using either the home Calgary Stampede Vac involving wall suction or the KCI AbThera Abdominal Dressing to dress the abdomen whenever the operative surgeon determines that an open abdomen is warranted to treat the patient
In general others have hypothesized that cytokines especially peritoneal levels are sensitive indicators of the post-operative inflammatory reaction and may predict complications In experimental models IL-6 levels are higher in non-survivors Further previous work has noted that the blood level of IL-6 which has a longer half life than TNF-α or IL-1β is a good index of the overall cytokine cascade activation Thus the main outcomes to be compared will be between mean cytokine levels measured in each of the two treatment groups - to determine if the KCI AbThera Abdominal Dressing can significantly reduce the blood concentration of IL-6 when compared with the Stampede VAC system We are hoping to better understand how the body responds to the inflammatory process that naturally occurs during and after an episode of intra-abdominal hypertension to identify signals or markers of inflammation and infection as well as its progression and outcome
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