Clinical trial NCT01784458: Clinical Significance of Intra-abdominal Hypertension in Surgical Patients With Severe Sepsis
Official title: Observational Study of Relationship Between Intra-abdominal Hypertension and Severe Sepsis in Surgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bowel Perforation
Abscess
Leakage
Peritonitis
Pneumonia
Keywords: severe sepsis
intra-abdominal hypertension
intra-abdominal pressure
Lead sponsor: University of Ulsan
Sponsor class: OTHER
First posted: 2013-02-05
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients admitted to surgical intensive care unit with severe sepsis

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

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 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

Primary outcomes:
measure: effects of intra-abdominal hypertension on clinical course and outcome in surgical patients with severe sepsis
timeFrame: within 60 days after admission in surgical intensive care unit
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Division of Trauma and Surgical Critical Care, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea
name: Suk-Kyung Hong
role: STUDY_DIRECTOR
References:
citation: Cheatham ML, Malbrain ML, Kirkpatrick A, Sugrue M, Parr M, De Waele J, Balogh Z, Leppaniemi A, Olvera C, Ivatury R, D'Amours S, Wendon J, Hillman K, Wilmer A. Results from the International Conference of Experts on Intra-abdominal Hypertension and Abdominal Compartment Syndrome. II. Recommendations. Intensive Care Med. 2007 Jun;33(6):951-62. doi: 10.1007/s00134-007-0592-4. Epub 2007 Mar 22.
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citation: Hering R, Wrigge H, Vorwerk R, Brensing KA, Schroder S, Zinserling J, Hoeft A, Spiegel TV, Putensen C. The effects of prone positioning on intraabdominal pressure and cardiovascular and renal function in patients with acute lung injury. Anesth Analg. 2001 May;92(5):1226-31. doi: 10.1097/00000539-200105000-00027.
citation: Malbrain ML, Chiumello D, Pelosi P, Bihari D, Innes R, Ranieri VM, Del Turco M, Wilmer A, Brienza N, Malcangi V, Cohen J, Japiassu A, De Keulenaer BL, Daelemans R, Jacquet L, Laterre PF, Frank G, de Souza P, Cesana B, Gattinoni L. Incidence and prognosis of intraabdominal hypertension in a mixed population of critically ill patients: a multiple-center epidemiological study. Crit Care Med. 2005 Feb;33(2):315-22. doi: 10.1097/01.ccm.0000153408.09806.1b.
citation: Malbrain ML, Cheatham ML, Kirkpatrick A, Sugrue M, Parr M, De Waele J, Balogh Z, Leppaniemi A, Olvera C, Ivatury R, D'Amours S, Wendon J, Hillman K, Johansson K, Kolkman K, Wilmer A. Results from the International Conference of Experts on Intra-abdominal Hypertension and Abdominal Compartment Syndrome. I. Definitions. Intensive Care Med. 2006 Nov;32(11):1722-32. doi: 10.1007/s00134-006-0349-5. Epub 2006 Sep 12.
citation: Kyoung KH, Hong SK. The duration of intra-abdominal hypertension strongly predicts outcomes for the critically ill surgical patients: a prospective observational study. World J Emerg Surg. 2015 May 30;10:22. doi: 10.1186/s13017-015-0016-7. eCollection 2015.