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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyu-Hyouck Kyoung, University of Ulsan
ClinicalTrials.gov Identifier:
NCT01784458
First received: February 3, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  Purpose
  • 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
Bowel Perforation
Abscess
Leakage
Peritonitis
Pneumonia

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Ulsan:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    length of ICU stay length of hospital stay ventilator free days effect on enteral feeding 28 day and 60 day mortality


Enrollment: 46
Study Start Date: March 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
intra-abdominal hypertension(IAH)
IAH group : patients developing IAH non-IAH group : patients without IAH

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients admitted to surgical intensive care unit with severe sepsis

Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01784458

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
  More Information

Publications:

Responsible Party: Kyu-Hyouck Kyoung, kyu-Hyouck Kyoung/clinical assistant professor, University of Ulsan
ClinicalTrials.gov Identifier: NCT01784458     History of Changes
Other Study ID Numbers: 2009-0004
Study First Received: February 3, 2013
Last Updated: February 3, 2013
Health Authority: Republic of Korea: Institutional Review Board

Keywords provided by University of Ulsan:
severe sepsis
intra-abdominal hypertension
intra-abdominal pressure

Additional relevant MeSH terms:
Abscess
Hypertension
Intestinal Perforation
Peritonitis
Pneumonia
Sepsis
Intra-Abdominal Hypertension
Suppuration
Infection
Inflammation
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intraabdominal Infections
Peritoneal Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Systemic Inflammatory Response Syndrome
Compartment Syndromes
Muscular Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 20, 2014