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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01784458
Recruitment Status : Completed
First Posted : February 5, 2013
Last Update Posted : February 5, 2013
Information provided by (Responsible Party):
Kyu-Hyouck Kyoung, 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

Condition or disease
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

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Study Type : Observational [Patient Registry]
Actual Enrollment : 46 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Months
Official Title: Observational Study of Relationship Between Intra-abdominal Hypertension and Severe Sepsis in Surgical Patients
Study Start Date : March 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

intra-abdominal hypertension(IAH)
IAH group : patients developing IAH non-IAH group : patients without IAH

Primary Outcome Measures :
  1. effects of intra-abdominal hypertension on clinical course and outcome in surgical patients with severe sepsis [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients admitted to surgical intensive care unit with severe sepsis

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01784458

Sponsors and Collaborators
University of Ulsan
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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

Additional Information:

Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Kyu-Hyouck Kyoung, kyu-Hyouck Kyoung/clinical assistant professor, University of Ulsan Identifier: NCT01784458     History of Changes
Other Study ID Numbers: 2009-0004
First Posted: February 5, 2013    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: February 2013
Keywords provided by Kyu-Hyouck Kyoung, University of Ulsan:
severe sepsis
intra-abdominal hypertension
intra-abdominal pressure
Additional relevant MeSH terms:
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Intra-Abdominal Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes
Intraabdominal Infections
Peritoneal Diseases
Digestive System Diseases
Compartment Syndromes
Muscular Diseases
Musculoskeletal Diseases