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

February 3, 2013
February 3, 2013
March 2009
October 2009   (final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
Not Provided
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Clinical Significance of Intra-abdominal Hypertension in Surgical Patients With Severe Sepsis
Observational Study of Relationship Between Intra-abdominal Hypertension and Severe Sepsis in Surgical Patients
  • 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
  • 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
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
2 Months
Not Provided
Non-Probability Sample

patients admitted to surgical intensive care unit with severe sepsis

  • Bowel Perforation
  • Abscess
  • Leakage
  • Peritonitis
  • Pneumonia
Not Provided
intra-abdominal hypertension(IAH)
IAH group : patients developing IAH non-IAH group : patients without IAH

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
October 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01784458
2009-0004
No
Kyu-Hyouck Kyoung, University of Ulsan
University of Ulsan
Not Provided
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
University of Ulsan
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP