Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Bladder Pressure Predicting Renal Failure in Critically Ill Patients as Compared to Hemodynamic Parameters

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Suzanne El-Sayegh, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01363505
First received: May 24, 2011
Last updated: January 31, 2014
Last verified: January 2014

May 24, 2011
January 31, 2014
May 2011
April 2013   (final data collection date for primary outcome measure)
High intraabdominal pressure and effect on renal function [ Time Frame: from admission (baseline) until 72 hours later ] [ Designated as safety issue: Yes ]
IAP measurements will be recorded concomitantly with renal indices. Correlations will be made in regard to pressure measurements and worsening renal function.
High intraabdominal pressure and effect on renal function [ Time Frame: from admission (baseline) until 72 hours later ] [ Designated as safety issue: Yes ]
Our primary outcome is to determine if we can correlate the intraabdominal pressure recorded on our monitor and the incidence of renal failure. We hope to determine a point at which this pressure is critical and leads to this endpoint.
Complete list of historical versions of study NCT01363505 on ClinicalTrials.gov Archive Site
Effect of diuretics use on intrabdominal pressure [ Time Frame: 3 days from admission ] [ Designated as safety issue: Yes ]
Early initiation of diuretics in acute heart failure improvement correlating with decreasing IAP measurements.
Effect of diuretics use on intrabdominal pressure [ Time Frame: 3 days from admission ] [ Designated as safety issue: Yes ]
we will try to show in our study that early use of diuretics in acute hbeart failure patients will decrease intrabdominal pressure and prevent renal failure from happening
Not Provided
Not Provided
 
Bladder Pressure Predicting Renal Failure in Critically Ill Patients as Compared to Hemodynamic Parameters
Is Intravesicular Pressure a Better Tool to Predict Renal Failure in Critically Ill Patients Compared With Routine Hemodynamic Parameters?

Studies have shown that more than 30% of the overall acute decompensated heart failure (ADHF) patients develop renal dysfunction.

Several studies have tried to find a correlation between hemodynamic Parameters (blood pressure , heart rate, central venous pressure CVP) and worsening of renal function in acute decompensated heart failure patients.

Results showed that there were no correlation between baseline hemodynamics or change in hemodynamics and worsening of renal function.

Another study showed that intra-abdominal pressure (IAP) measuring was a better corollary to renal failure status then measuring cardiovascular hemodynamics using pulmonary artery catheterization in ADHF patients.. An increased IAP was associated with worse renal function and that level of IAP far below abdominal compartment syndrome may adversely affect renal function in patients with ADHF.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

The studied group will consist of patients admitted to the ICU (intensive care unit) or CCU(coronary care ubnit) with evidence of ADHF. We aim in our study to find out if there is a linear relationship between worsening of renal function , IAP ,hemodynamic (CVP) and blood chemical measurements

  • Acute Heart Failure
  • Acute Renal Failure
Device: BARD® Intra-abdominal Pressure monitor
monitor linked to foley catheter that is able to measure pressure inside bladder
Other Name: BARD® Intra-abdominal Pressure monitor
Acute CHF patients
Acute CHF patients with BARD Intra-abdominal pressure monitors in ICU
Intervention: Device: BARD® Intra-abdominal Pressure monitor

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
April 2013
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Any ICU(intensive care unit) or CCU(critical care unit) patient older than 18 y.
  • Patient diagnosed on admission with pulmonary edema/CHF (fluid in the lungs) - independently from the baseline renal function.
  • No subject will be accepted to take part in the study unless they are able to sign or if Health care proxy signs a consent

Exclusion Criteria:

  • Pregnant women
  • Cognitively impaired patients
  • Age<18 yrs old
  • Patients diagnosed on admission with ARDS.
  • Patients admitted with a diagnosis of sepsis ( WBC> 12000, CXR findings consistent with pneumonia, positive blood cultures on admission, UTI)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01363505
11-021
Yes
Suzanne El-Sayegh, North Shore Long Island Jewish Health System
North Shore Long Island Jewish Health System
Not Provided
Study Director: Suzanne El-Sayegh, MD Staten Island University Hospital
North Shore Long Island Jewish Health System
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP