Bowel PerforationNCT01784458
Clinical Significance of Intra-abdominal Hypertension in Surgical Patients With Severe Sepsis
An observational study of Bowel Perforation and Abscess, run by University of Ulsan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Perforation, Abscess, Leakage
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Oct 2009
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients admitted to surgical intensive care unit with severe sepsis
Who may be able to join
- older than 18-year
- agreed on informed consent
- diagnosed with severe sepsis
Who cannot join
- traumatic injuries on urethra or bladder
- open abdomen status
About this study
Official title: Observational Study of Relationship Between Intra-abdominal Hypertension and Severe Sepsis in Surgical Patients
- 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
- Conditions
- Bowel Perforation, Abscess, Leakage, Peritonitis, Pneumonia
- Keywords
- severe sepsis, intra-abdominal hypertension, intra-abdominal pressure
- Medical subject headings
- Intestinal Perforation, Abscess, Peritonitis, Pneumonia, Sepsis, Intra-Abdominal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| intra-abdominal hypertension(IAH) | IAH group : patients developing IAH non-IAH group : patients without IAH |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 60 days after admission in surgical intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startMar 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bowel PerforationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- University of Ulsan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyu-Hyouck Kyoung, University of Ulsan
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784458
- Sponsor's protocol ID
- 2009-0004
- Status last verified
- Feb 2013
- First submitted
- 3 Feb 2013
- Last updated
- 5 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
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 17377769Pelosi 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 9074968Hering 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 11323351Malbrain 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 15699833Malbrain 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 16967294Kyoung 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Relationship Between Intra-abdominal Hypertension and Severe Sepsis in Surgical Patients
- ClinicalTrials.gov ID
- NCT01784458
- Acronym / sponsor ID
- 2009-0004
- Conditions
- Bowel Perforation, Abscess, Leakage, Peritonitis, Pneumonia
- Keywords
- severe sepsis, intra-abdominal hypertension, intra-abdominal pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of UlsanUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 5 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intra-abdominal hypertension(IAH) | – | –IAH group : patients developing IAH non-IAH group : patients without IAH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted to surgical intensive care unit with severe sepsis
Key inclusion criteria (3 listed)
- older than 18-year
- agreed on informed consent
- diagnosed with severe sepsis
Key exclusion criteria (2 listed)
- traumatic injuries on urethra or bladder
- open abdomen status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
length of ICU stay length of hospital stay ventilator free days effect on enteral feeding 28 day and 60 day mortality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2013.
- Background: PubMed 17377769Cheatham 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.
- Background: PubMed 9074968Pelosi 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.
- Background: PubMed 11323351Hering 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.
- Background: PubMed 15699833Malbrain 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.
- Results publication: PubMed 16967294Malbrain 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.
- Derived from this study: PubMed 26056530Kyoung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
Questions about this trial
What is this clinical trial studying?
An observational study of Bowel Perforation and Abscess, run by University of Ulsan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01784458, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2013.