Ignite Creation Date:
2024-05-06 @ 7:23 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02520440
Status:
COMPLETED
Last Update Posted:
2015-08-11
First Post:
2015-08-06
Brief Title:
INtestinal Failure multiPle Organ Failure ANd CItrulline Assessment
Sponsor:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Organization:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Study Overview
Official Title:
Clinical Evaluation of Gastro Intestinal Failure Multiple Organ Failure and Levels of Citrulline in Critical Ill Patients
Status:
COMPLETED
Status Verified Date:
2015-08
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:
IN-PANCIA
Brief Summary:
The gastrointestinal dysfunction occurs frequently during the intensive care unit ICU stay and is associated with a worse prognosis
The gastrointestinal failure GIF is diagnosed based on symptoms such as bowel distension ileus diarrhea digestive bleeding or intestinal ischemia A GIF score based on has been demonstrated to be correlated with outcome with higher scores indicating higher risk of death However GIF may be occult or clinical signs can go undetected in critically ill patients due to the frequent use of analgesic sedative or neuromuscular blocking agents acute neurologic diseases or delirium
Citrulline is a potential biomarker for small bowel function in critically ill patients with maintained renal function Normal plasma citrulline levels 12-55 µmolL are determined by the balance between gut synthesis and kidney degradation
GIF is involved in the pathogenesis of multiple organ dysfunctions and failures MOF through various mechanisms and it is often associated with high intra-abdominal pressure IAP IAP greater than 12 mmHg may lead to abdominal compartment syndrome ACS and MOF including cardiac respiratory and kidney failure Studies have suggested that GIF can be the consequence rather than the cause of MOF
The aim of this study is to investigate if plasma citrulline levels is associated with a clinical diagnosis of GIF and may predict the development of MOF
The gastrointestinal failure GIF is diagnosed based on symptoms such as bowel distension ileus diarrhea digestive bleeding or intestinal ischemia A GIF score based on has been demonstrated to be correlated with outcome with higher scores indicating higher risk of death However GIF may be occult or clinical signs can go undetected in critically ill patients due to the frequent use of analgesic sedative or neuromuscular blocking agents acute neurologic diseases or delirium
Citrulline is a potential biomarker for small bowel function in critically ill patients with maintained renal function Normal plasma citrulline levels 12-55 µmolL are determined by the balance between gut synthesis and kidney degradation
GIF is involved in the pathogenesis of multiple organ dysfunctions and failures MOF through various mechanisms and it is often associated with high intra-abdominal pressure IAP IAP greater than 12 mmHg may lead to abdominal compartment syndrome ACS and MOF including cardiac respiratory and kidney failure Studies have suggested that GIF can be the consequence rather than the cause of MOF
The aim of this study is to investigate if plasma citrulline levels is associated with a clinical diagnosis of GIF and may predict the development of MOF
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