Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-10 @ 7:09 PM
Study NCT ID:
NCT01784458
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
2013-02-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Significance of Intra-abdominal Hypertension in Surgical Patients With Severe Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007416', 'term': 'Intestinal Perforation'}, {'id': 'D000038', 'term': 'Abscess'}, {'id': 'D010538', 'term': 'Peritonitis'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D059325', 'term': 'Intra-Abdominal Hypertension'}], 'ancestors': [{'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D003161', 'term': 'Compartment Syndromes'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}, 'targetDuration': '2 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-03', 'studyFirstSubmitDate': '2013-02-03', 'studyFirstSubmitQcDate': '2013-02-03', 'lastUpdatePostDateStruct': {'date': '2013-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': 'length of ICU stay length of hospital stay ventilator free days effect on enteral feeding 28 day and 60 day mortality'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['severe sepsis', 'intra-abdominal hypertension', 'intra-abdominal pressure'], 'conditions': ['Bowel Perforation', 'Abscess', 'Leakage', 'Peritonitis', 'Pneumonia']}, 'referencesModule': {'references': [{'pmid': '17377769', 'type': 'BACKGROUND', '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."}, {'pmid': '9074968', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11323351', 'type': 'BACKGROUND', '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.'}, {'pmid': '15699833', 'type': 'BACKGROUND', '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.'}, {'pmid': '16967294', 'type': 'RESULT', '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."}, {'pmid': '26056530', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '* Intra-abdominal pressure(IAP) is defined as a steady state pressure of the abdominal cavity\n* many studies have proved IAP as a prognostic factor that elevated IAP influences hemodynamics and multiple organs dysfunction\n* 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\n* 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\n* 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', 'detailedDescription': '* Inclusion criteria older than 18 diagnosed as severe sepsis agreed on informed consent\n* Exclusion criteria refused to participate in the study traumatic injuries on urethra or bladder open abdomen status\n* 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\n* Definition of intra-abdominal hypertension intra-abdominal pressure more than 12mmHg\n* 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients admitted to surgical intensive care unit with severe sepsis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* older than 18-year\n* agreed on informed consent\n* diagnosed with severe sepsis\n\nExclusion Criteria:\n\n* traumatic injuries on urethra or bladder\n* open abdomen status'}, 'identificationModule': {'nctId': 'NCT01784458', 'briefTitle': 'Clinical Significance of Intra-abdominal Hypertension in Surgical Patients With Severe Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulsan'}, 'officialTitle': 'Observational Study of Relationship Between Intra-abdominal Hypertension and Severe Sepsis in Surgical Patients', 'orgStudyIdInfo': {'id': '2009-0004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'intra-abdominal hypertension(IAH)', 'description': 'IAH group : patients developing IAH non-IAH group : patients without IAH'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Suk-Kyung Hong', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Division of Trauma and Surgical Critical Care, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulsan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'kyu-Hyouck Kyoung/clinical assistant professor', 'investigatorFullName': 'Kyu-Hyouck Kyoung', 'investigatorAffiliation': 'University of Ulsan'}}}}