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

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01784458
• Other study ID #: 2009-0004
• Status: Completed
• Phase: N/A
• First received: February 3, 2013
• Last updated: February 3, 2013
• Start date: March 2009
• Est. completion date: October 2009

Study information

• Verified date: February 2013
• Source: University of Ulsan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Republic of Korea: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abscess
• Bowel Perforation
• Hypertension
• Intestinal Perforation
• Intra-Abdominal Hypertension
• Leakage
• Peritonitis
• Pneumonia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulsan

References & Publications (5)

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. — View Citation

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. — View Citation

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 — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes