Intra-Abdominal HypertensionNCT00747552
Intra-Abdominal Hypertension in Neonatal Intensive Care Patients
An observational study of Intra-Abdominal Hypertension, run by University of Utah at 1 site in United States.
Trial summary
The observational study is designed to determine the feasibility of performing Intra-Abdominal Pressure (IAP) via bladder pressure measurements and of tracking IAP in neonates who require bladder catheterization. Read more about this study
- Who is it for?
- Ages Up to 2 months
- Conditions the study is for
- Intra-Abdominal Hypertension
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to May 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 2 months
- All sexes
- No healthy volunteers
- Child
Study population: This is a prospective observational study. A convenience sample of 50 NICU patients will be planned to be enrolled at Primary Children's Medical Center and/or the University of Utah Hospital.
Who may be able to join
- Any NICU patient is eligible for enrollment in this study if his/her medical condition has required the placement of a bladder catheter for urine drainage and who does not meet any of the following Exclusion Criteria.
Who cannot join
- Bladder trauma
- History of recent bladder surgery
- Neurogenic bladder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah / Primary Childrens Medical Center
Salt Lake City, Utah, 84132
About this study
The observational study is designed to determine the feasibility of performing Intra-Abdominal Pressure (IAP) via bladder pressure measurements and of tracking IAP in neonates who require bladder catheterization. Correlation of IAP measurements with clinical status of the neonatal abdomen will help determine threshold values for Intra-Abdominal Hypertension (IAH) in the neonate.
Read the detailed description
An increasingly common cause of Multiple Organ Dysfunction Syndrome (MODS) is mechanical injury/ischemia caused by elevated pressures within the abdominal cavity. This phenomenon has been termed intra-abdominal hypertension (IAH) with the final pathway of multiple organ dysfunction and failure termed abdominal compartment syndrome (ACS). In the neonate, IAH is known to accompany omphalocele, gastroschisis and diaphragmatic hernia repair. IAH has also been found to cause a need for neonatal extra corporeal membrane oxygenation (ECMO) and/or a subsequent failure of ECMO treatment.
While abdominal compartment syndrome is the final physiologic and clinically apparent expression of severe elevations of intra-abdominal pressure, earlier in the course of this process, significant organ dysfunction occurs at a sub-clinical level. If mild to moderately elevated abdominal pressure can be detected early, it may allow clinicians to intervene early and reverse the process, preventing progression to ACS and possibly reducing morbidity and mortality.
To date no study has investigated the correlation between bladder pressure (a surrogate measure of IAP) in neonates who may or may not have ACS. Thus, the ranges of normal and elevated IAP are not determined. There is suggestion from pediatric ICU patients that the threshold for IAH in children is less than that in adults. Likewise, the threshold for IAH in neonates may be expected to be even lower, but this remains to be determined.
In this study, IAP (via bladder pressure measurements) will be measured with a commercially available and FDA approved system which utilizes an electronic pressure transducer, tubing, and any bedside patient monitor with pressure measurement inputs. These types of monitors are standard in the NICU. The pressure transducer is attached to the bladder catheter via a two-way valve, allowing urine drainage in-between taking bladder pressure measurements. A small amount of sterile saline is infused into the bladder in order to make the IAP measurement. While there is an indwelling urinary catheter, bladder pressure measurements will be taken every 2-4 hours.
- Conditions
- Intra-Abdominal Hypertension
- Keywords
- IAP measurements, Abdominal compartment syndrome, NICU patients, Intra-abdominal Hypertension
- Medical subject headings
- Intra-Abdominal Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-abdominal Pressure(IAP) Measurements in NICU Patients.
Intra-abdominal Pressure (IAP) measurements were taken using an electronic pressure transducer via an indwelling urinary catheter. Measurements were obtained every 2-4 hours while the urinary catheter remained in place. This will be used to determine feasability of using a urinary catheter and electronic pressure transducer system to determine IAP. A total of 1219 measurements were obtained from 30 subjects.
Measured: 3 years
Secondary outcomes (1)
Median Bladder Pressure for All Measurements
Intra-abdominal Pressure (IAP) measurements will be tabulated and frequency distributions determined for patients with and without any clinical/surgical abdominal pathology. Median and quartile values will be assessed in order to describe normative values. In patients with clinical abdominal pathology (abdominal distention, necrotizing enterocolitis, abdominal wall defects, diaphragmatic hernia, etc), sequential evaluation of IAP will be done to try to identify thresholds for Intra-abdominal Hypertension (IAH).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2008 (estimated)
- Study startJan 2006
- Primary completionApr 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intra-Abdominal HypertensionStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Investigators
- Donald .Null, M.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747552
- Sponsor's protocol ID
- 13833
- Status last verified
- Jan 2010
- First submitted
- 3 Sep 2008
- Last updated
- 26 Jan 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Abdominal Hypertension in Neonatal Intensive Care Patients
- ClinicalTrials.gov ID
- NCT00747552
- Acronym / sponsor ID
- 13833
- Conditions
- Intra-Abdominal Hypertension
- Keywords
- IAP measurements, Abdominal compartment syndrome, NICU patients, Intra-abdominal Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 5 Sep 2008 (estimated)
- Results
- Posted 18 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The observational study is designed to determine the feasibility of performing Intra-Abdominal Pressure (IAP) via bladder pressure measurements and of tracking IAP in neonates who require bladder catheterization. Correlation of IAP measurements with clinical status of the neonatal abdomen will help determine threshold values for Intra-Abdominal Hypertension (IAH) in the neonate.
Detailed description
An increasingly common cause of Multiple Organ Dysfunction Syndrome (MODS) is mechanical injury/ischemia caused by elevated pressures within the abdominal cavity. This phenomenon has been termed intra-abdominal hypertension (IAH) with the final pathway of multiple organ dysfunction and failure termed abdominal compartment syndrome (ACS). In the neonate, IAH is known to accompany omphalocele, gastroschisis and diaphragmatic hernia repair. IAH has also been found to cause a need for neonatal extra corporeal membrane oxygenation (ECMO) and/or a subsequent failure of ECMO treatment.
While abdominal compartment syndrome is the final physiologic and clinically apparent expression of severe elevations of intra-abdominal pressure, earlier in the course of this process, significant organ dysfunction occurs at a sub-clinical level. If mild to moderately elevated abdominal pressure can be detected early, it may allow clinicians to intervene early and reverse the process, preventing progression to ACS and possibly reducing morbidity and mortality.
To date no study has investigated the correlation between bladder pressure (a surrogate measure of IAP) in neonates who may or may not have ACS. Thus, the ranges of normal and elevated IAP are not determined. There is suggestion from pediatric ICU patients that the threshold for IAH in children is less than that in adults. Likewise, the threshold for IAH in neonates may be expected to be even lower, but this remains to be determined.
In this study, IAP (via bladder pressure measurements) will be measured with a commercially available and FDA approved system which utilizes an electronic pressure transducer, tubing, and any bedside patient monitor with pressure measurement inputs. These types of monitors are standard in the NICU. The pressure transducer is attached to the bladder catheter via a two-way valve, allowing urine drainage in-between taking bladder pressure measurements. A small amount of sterile saline is infused into the bladder in order to make the IAP measurement. While there is an indwelling urinary catheter, bladder pressure measurements will be taken every 2-4 hours.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This is a prospective observational study. A convenience sample of 50 NICU patients will be planned to be enrolled at Primary Children's Medical Center and/or the University of Utah Hospital.
Key inclusion criteria (1 listed)
- Any NICU patient is eligible for enrollment in this study if his/her medical condition has required the placement of a bladder catheter for urine drainage and who does not meet any of the following Exclusion Criteria.
Key exclusion criteria (3 listed)
- Bladder trauma
- History of recent bladder surgery
- Neurogenic bladder
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
Intra-abdominal Pressure(IAP) Measurements in NICU Patients.
Time frame: 3 years
Intra-abdominal Pressure (IAP) measurements were taken using an electronic pressure transducer via an indwelling urinary catheter. Measurements were obtained every 2-4 hours while the urinary catheter remained in place. This will be used to determine feasability of using a urinary catheter and electronic pressure transducer system to determine IAP. A total of 1219 measurements were obtained from 30 subjects.
1 secondary outcome
Median Bladder Pressure for All Measurements
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Donald .Null, M.D. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intra-Abdominal Hypertension, run by University of Utah at 1 site in United States.
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 1 inclusion and 3 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 26 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 18 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intra-abdominal Pressure(IAP) Measurements in NICU Patients. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2010.