Clinical Significance of Intra-abdominal Hypertension in Surgical Patients With Severe Sepsis

Completed

• Conditions: Bowel Perforation; Abscess; Leakage; Peritonitis; Pneumonia

• Registration Number: NCT01784458
• Lead Sponsor: University of Ulsan

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

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

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2013-02
• Study First Submitted: 2013-02-03
• Study First Submitted QC: 2013-02-03
• Last Update Submitted: 2013-02-03
• Study First Posted: 2013-02-05
• Last Update Posted: 2013-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• older than 18-year
• agreed on informed consent
• diagnosed with severe sepsis

Exclusion Criteria

• traumatic injuries on urethra or bladder
• open abdomen status

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
effects of intra-abdominal hypertension on clinical course and outcome in surgical patients with severe sepsis	within 60 days after admission in surgical intensive care unit	length of ICU stay length of hospital stay ventilator free days effect on enteral feeding 28 day and 60 day mortality