Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
Study NCT ID:
NCT01784458
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
2013-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Significance of Intra-abdominal Hypertension in Surgical Patients With Severe Sepsis
Sponsor:
University of Ulsan
Organization:
Study Overview
Official Title:
Observational Study of Relationship Between Intra-abdominal Hypertension and Severe Sepsis in Surgical Patients
Status:
COMPLETED
Status Verified Date:
2013-02
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:
None
Brief Summary:
* Intra-abdominal pressure(IAP) is defined as a steady state pressure of the abdominal cavity
* many studies have proved IAP as a prognostic factor that elevated IAP influences hemodynamics and multiple organs dysfunction
* In previous studies, most of them was based on the septic patients of medical diseases. And it is rare about sepsis of surgical diseases such as traumatized or postoperative patients
* We hypothesized that intra-abdominal hypertension may affect clinical course such as length of stay of intensive care unit, weaning of mechanical ventilation, proceeding of enteral feeding and mortality
* Our study was aimed to investigate prevalence of IAH and risk factors and to analyze clinical course and prognosis influenced by IAH in surgical patients with severe sepsis
* many studies have proved IAP as a prognostic factor that elevated IAP influences hemodynamics and multiple organs dysfunction
* In previous studies, most of them was based on the septic patients of medical diseases. And it is rare about sepsis of surgical diseases such as traumatized or postoperative patients
* We hypothesized that intra-abdominal hypertension may affect clinical course such as length of stay of intensive care unit, weaning of mechanical ventilation, proceeding of enteral feeding and mortality
* Our study was aimed to investigate prevalence of IAH and risk factors and to analyze clinical course and prognosis influenced by IAH in surgical patients with severe sepsis
Detailed Description:
* Inclusion criteria older than 18 diagnosed as severe sepsis agreed on informed consent
* Exclusion criteria refused to participate in the study traumatic injuries on urethra or bladder open abdomen status
* Definition of severe sepsis organ failure more than one organ with sepsis arterial blood lactate concentration of at least 4mmol/L hypotension with a systolic blood pressure lower than 90mmHg
* Definition of intra-abdominal hypertension intra-abdominal pressure more than 12mmHg
* Measurement of IAP measuring via three lument urinary catheter measuring after filling with 25ml normal saline measuring in supine position at level of mid-axillary line on iliac crest measuring three times a day during ICU stay
* Exclusion criteria refused to participate in the study traumatic injuries on urethra or bladder open abdomen status
* Definition of severe sepsis organ failure more than one organ with sepsis arterial blood lactate concentration of at least 4mmol/L hypotension with a systolic blood pressure lower than 90mmHg
* Definition of intra-abdominal hypertension intra-abdominal pressure more than 12mmHg
* Measurement of IAP measuring via three lument urinary catheter measuring after filling with 25ml normal saline measuring in supine position at level of mid-axillary line on iliac crest measuring three times a day during ICU stay
Study Oversight
Has Oversight DMC:
False
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?: