Intra-Abdominal Hypertension in Neonatal Intensive Care Patients

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.

Study Overview

• Status: Completed
• Conditions: Intra-Abdominal Hypertension

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah / Primary Childrens Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	3 years

Collaborators and Investigators

• Sponsor: University of Utah

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: September 3, 2008
• First Submitted That Met QC Criteria: September 4, 2008
• First Posted (Estimate): September 5, 2008

Study Record Updates

• Last Update Posted (Estimate): January 26, 2010
• Last Update Submitted That Met QC Criteria: January 22, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: IAP measurements; Abdominal compartment syndrome; NICU patients; Intra-abdominal Hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Musculoskeletal Diseases; Muscular Diseases; Compartment Syndromes; Hypertension; Intra-Abdominal Hypertension
• Other Study ID Numbers: 13833