Intra-Abdominal Hypertension in Neonatal Intensive Care Patients
Study Details
Study Description
Brief 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. 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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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
Outcome Measures
Primary Outcome Measures
- Intra-abdominal Pressure(IAP) Measurements in NICU Patients. [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.
Secondary Outcome Measures
- Median Bladder Pressure for All Measurements [3 years]
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).
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 13833
Study Results
Participant Flow
| Recruitment Details | From Jan 2006 to Apr 2008, 32 infants who were inpatients in NICU were enrolled into the study. |
|---|---|
| Pre-assignment Detail | 2 of the infants that were enrolled had the urinary catheter removed prior to any data collection. As the presence of a urinary catheter is necessary for bladder measurements, no data was able to be collected and therefore never actually started in the study. |
| Arm/Group Title | Infants With Urinary Catheter in Place |
|---|---|
| Arm/Group Description | Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively. |
| Period Title: Overall Study | |
| STARTED | 30 |
| COMPLETED | 30 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Infants With Urinary Catheter in Place |
|---|---|
| Arm/Group Description | Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively. |
| Overall Participants | 30 |
| Age (Count of Participants) | |
| <=18 years |
30
100%
|
| Between 18 and 65 years |
0
0%
|
| >=65 years |
0
0%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
14
46.7%
|
| Male |
16
53.3%
|
| Region of Enrollment (participants) [Number] | |
| United States |
30
100%
|
Outcome Measures
| Title | Intra-abdominal Pressure(IAP) Measurements in NICU Patients. |
|---|---|
| Description | 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. |
| Time Frame | 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| 18 of the neonates required staged abdominal surgery for various abdominal abnormalities or disease, while 12 of the neonates were ill due to PPHN, sepsis, or hydrops. All analysis was per protocol. |
| Arm/Group Title | Infants With Urinary Catheter in Place |
|---|---|
| Arm/Group Description | Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively. |
| Measure Participants | 30 |
| Number [IAP measurements] |
1219
|
| Title | Median Bladder Pressure for All Measurements |
|---|---|
| Description | 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). |
| Time Frame | 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| 18 of the neonates required staged abdominal surgery for various abdominal abnormalities or disease, while 12 of the neonates were ill due to PPHN, sepsis, or hydrops. All analysis was per protocol. |
| Arm/Group Title | Infants With Urinary Catheter in Place |
|---|---|
| Arm/Group Description | Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively. |
| Measure Participants | 30 |
| Median (Inter-Quartile Range) [mmHg] |
8
(7.1)
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Infants With Urinary Catheter in Place | |
| Arm/Group Description | Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively. | |
All Cause Mortality |
||
| Infants With Urinary Catheter in Place | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Infants With Urinary Catheter in Place | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Infants With Urinary Catheter in Place | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Donald Null M.D. |
|---|---|
| Organization | University of Utah |
| Phone | 801.588-3865 |
| donald.null@imail.org |
- 13833