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

Study Overview

• Status: Completed
• Conditions: Pneumonia; Abscess; Peritonitis; Leakage; Bowel Perforation

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

• Study Type: Observational
• Enrollment (Actual): 46

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients admitted to surgical intensive care unit with severe sepsis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
intra-abdominal hypertension(IAH); IAH group : patients developing IAH non-IAH group : patients without IAH

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effects of intra-abdominal hypertension on clinical course and outcome in surgical patients with severe sepsis	length of ICU stay length of hospital stay ventilator free days effect on enteral feeding 28 day and 60 day mortality	within 60 days after admission in surgical intensive care unit

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.
• 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.
• Pelosi P, Croci M, Ravagnan I, Cerisara M, Vicardi P, Lissoni A, Gattinoni L. Respiratory system mechanics in sedated, paralyzed, morbidly obese patients. J Appl Physiol (1985). 1997 Mar;82(3):811-8. doi: 10.1152/jappl.1997.82.3.811.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: February 3, 2013
• First Submitted That Met QC Criteria: February 3, 2013
• First Posted (Estimate): February 5, 2013

Study Record Updates

• Last Update Posted (Estimate): February 5, 2013
• Last Update Submitted That Met QC Criteria: February 3, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: intra-abdominal pressure; severe sepsis; intra-abdominal hypertension
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Peritoneal Diseases; Gastrointestinal Diseases; Musculoskeletal Diseases; Muscular Diseases; Intestinal Diseases; Intraabdominal Infections; Compartment Syndromes; Sepsis; Hypertension; Peritonitis; Intra-Abdominal Hypertension; Intestinal Perforation
• Other Study ID Numbers: 2009-0004