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NCT Number: NCT01784458

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

* 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

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Key information

Conditions

Bowel Perforation Abscess Cardiovascular Diseases Compartment Syndromes Digestive System Diseases Gastrointestinal Diseases Infections Inflammation Intestinal Diseases Intestinal Perforation Intra-Abdominal Hypertension Intraabdominal Infections Leakage Lung Diseases Muscular Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Diseases Peritonitis Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Sepsis Suppuration Systemic Inflammatory Response Syndrome Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Ulsan

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 5, 2013
Registry last updated
Feb 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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