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

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. Identifier: NCT01363505
Recruitment Status : Completed
First Posted : June 1, 2011
Last Update Posted : February 3, 2014
Information provided by (Responsible Party):
Suzanne El-Sayegh, Northwell Health

Brief Summary:

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.

Condition or disease Intervention/treatment
Acute Heart Failure Acute Renal Failure Device: BARD® Intra-abdominal Pressure monitor

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Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Is Intravesicular Pressure a Better Tool to Predict Renal Failure in Critically Ill Patients Compared With Routine Hemodynamic Parameters?
Study Start Date : May 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Group/Cohort Intervention/treatment
Acute CHF patients
Acute CHF patients with BARD Intra-abdominal pressure monitors in ICU
Device: BARD® Intra-abdominal Pressure monitor
monitor linked to foley catheter that is able to measure pressure inside bladder

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01363505

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United States, New York
Staten Island University Hospital
Staten Island, New York, United States, 10305
Sponsors and Collaborators
Northwell Health
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Study Director: Suzanne El-Sayegh, MD Staten Island University Hospital
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Responsible Party: Suzanne El-Sayegh, Nephrology Attending, Assoc. Chair of Medicine, Northwell Health Identifier: NCT01363505    
Other Study ID Numbers: 11-021
First Posted: June 1, 2011    Key Record Dates
Last Update Posted: February 3, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases