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CompletedNCT01784458Updated Feb 5, 2013

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

An observational study in Bowel Perforation, Abscess and Leakage, sponsored by University of Ulsan. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-05.

Sponsored by University of Ulsan · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
46
Ages
18 Years and older
Sex
All
01

Study 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
Read the 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
02

Conditions studied

  • Bowel Perforation
  • Abscess
  • Leakage
  • Peritonitis
  • Pneumonia

Keywords

  • severe sepsis
  • intra-abdominal hypertension
  • intra-abdominal pressure
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients admitted to surgical intensive care unit with severe sepsis

Inclusion criteria

  • older than 18-year
  • agreed on informed consent
  • diagnosed with severe sepsis

Exclusion criteria

Exclusion Criteria:

  • traumatic injuries on urethra or bladder
  • open abdomen status
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
46 participants (actual)
Target follow-up
2 Months
Patient registry
Yes

Groups and cohorts

  • intra-abdominal hypertension(IAH)

    IAH group : patients developing IAH non-IAH group : patients without IAH

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: within 60 days after admission in surgical intensive care unit

06

Study locations

No study locations are listed for this record.

07

References and documents

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. PubMed 17377769 ↗
  • 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. PubMed 9074968 ↗
  • 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. PubMed 11323351 ↗
  • 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. PubMed 15699833 ↗
  • 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. PubMed 16967294 ↗
  • 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. PubMed 26056530 ↗
08

Registry details

Key details

Study ID
NCT01784458
Lead sponsor
University of Ulsan
Responsible party
Kyu-Hyouck Kyoung (kyu-Hyouck Kyoung/clinical assistant professor, University of Ulsan) — Principal investigator
First posted
Feb 5, 2013
Start date
Mar 2009
Primary completion
Oct 2009
Completion
Oct 2009
Last update
Feb 5, 2013

Study contacts

Suk-Kyung Hong
study director · Division of Trauma and Surgical Critical Care, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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