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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01363505
First Posted: June 1, 2011
Last Update Posted: February 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Suzanne El-Sayegh, North Shore Long Island Jewish Health System
May 24, 2011
June 1, 2011
February 3, 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 ]
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 ]
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 ]
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 ]
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
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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.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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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
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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01363505
11-021
Yes
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Suzanne El-Sayegh, North Shore Long Island Jewish Health System
Northwell Health
Not Provided
Study Director: Suzanne El-Sayegh, MD Staten Island University Hospital
Northwell Health
January 2014