NCT01784458

Brief 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2009

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2013

Completed
Last Updated

February 5, 2013

Status Verified

February 1, 2013

Enrollment Period

7 months

First QC Date

February 3, 2013

Last Update Submit

February 3, 2013

Conditions

Keywords

severe sepsisintra-abdominal hypertensionintra-abdominal pressure

Outcome Measures

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

    within 60 days after admission in surgical intensive care unit

Study Arms (1)

intra-abdominal hypertension(IAH)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients admitted to surgical intensive care unit with severe sepsis

You may qualify if:

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

You may not qualify if:

  • traumatic injuries on urethra or bladder
  • open abdomen status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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: 17377769BACKGROUND
  • 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: 9074968BACKGROUND
  • 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: 11323351BACKGROUND
  • 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: 15699833BACKGROUND
  • 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.

MeSH Terms

Conditions

Intestinal PerforationAbscessPeritonitisPneumoniaSepsisIntra-Abdominal Hypertension

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesSuppurationInfectionsInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsIntraabdominal InfectionsPeritoneal DiseasesRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesSystemic Inflammatory Response SyndromeCompartment SyndromesMuscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Suk-Kyung Hong

    Division of Trauma and Surgical Critical Care, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
kyu-Hyouck Kyoung/clinical assistant professor

Study Record Dates

First Submitted

February 3, 2013

First Posted

February 5, 2013

Study Start

March 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

February 5, 2013

Record last verified: 2013-02