Intra-Abdominal Hypertension in Neonatal Intensive Care Patients

This study has been completed.
Sponsor:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00747552
First received: September 3, 2008
Last updated: January 22, 2010
Last verified: January 2010
  Purpose

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.


Condition
Intra-Abdominal Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intra-Abdominal Hypertension in Neonatal Intensive Care Patients

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Intra-abdominal Pressure(IAP) Measurements in NICU Patients. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Median Bladder Pressure for All Measurements [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: January 2006
Study Completion Date: May 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 2 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Bladder trauma
  • History of recent bladder surgery
  • Neurogenic bladder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00747552

Locations
United States, Utah
University of Utah / Primary Childrens Medical Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Donald .Null, M.D. University of Utah
  More Information

No publications provided

Responsible Party: Donald Null M.D., University of Utah
ClinicalTrials.gov Identifier: NCT00747552     History of Changes
Other Study ID Numbers: 13833
Study First Received: September 3, 2008
Results First Received: July 21, 2009
Last Updated: January 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
IAP measurements
Abdominal compartment syndrome
NICU patients
Intra-abdominal Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 22, 2014