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

Sponsor

University of Ulsan (Other)

Overall Status

Completed

CT.gov ID

NCT01784458

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Bowel Perforation Abscess Leakage Peritonitis Pneumonia

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

46 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Observational Study of Relationship Between Intra-abdominal Hypertension and Severe Sepsis in Surgical Patients

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
intra-abdominal hypertension(IAH) IAH group : patients developing IAH non-IAH group : patients without IAH

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Ulsan

Investigators

Study Director: Suk-Kyung Hong, Division of Trauma and Surgical Critical Care, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea