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

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:

MedlinePlus related topics: High Blood Pressure Pneumonia Sepsis

U.S. FDA Resources

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

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:

Malbrain ML, Cheatham ML, Kirkpatrick A, Sugrue M, Parr M, De Waele J, Balogh Z, Leppäniemi 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. Epub 2006 Sep 12.

Cheatham ML, Malbrain ML, Kirkpatrick A, Sugrue M, Parr M, De Waele J, Balogh Z, Leppäniemi 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. Epub 2007 Mar 22.

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. 1997 Mar;82(3):811-8.

Hering R, Wrigge H, Vorwerk R, Brensing KA, Schröder 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.

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.

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
Suppuration
Infection
Inflammation
Pathologic Processes

Vascular Diseases
Cardiovascular Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Peritoneal Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on May 16, 2013