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

This study is currently recruiting participants.

Verified May 2013 by North Shore Long Island Jewish Health System

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: May 14, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

May 24, 2011

Last Updated Date

May 14, 2013

Start Date ^ICMJE

May 2011

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

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.

Change History

Complete list of historical versions of study NCT01363505 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Is Intravesicular Pressure a Better Tool to Predict Renal Failure in Critically Ill Patients Compared With Routine Hemodynamic Parameters?

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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

Condition ^ICMJE

Acute Heart Failure
Acute Renal Failure

Intervention ^ICMJE

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

Study Group/Cohort (s)

Acute CHF patients

Acute CHF patients with BARD Intra-abdominal pressure monitors in ICU

Intervention: Device: BARD® Intra-abdominal Pressure monitor

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Elie El-Charabaty, MD

718-226-9131

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01363505

Other Study ID Numbers ^ICMJE

11-021

Has Data Monitoring Committee

Yes

Responsible Party

Suzanne El-Sayegh, North Shore Long Island Jewish Health System

Study Sponsor ^ICMJE

North Shore Long Island Jewish Health System

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Suzanne El-Sayegh, MD

Staten Island University Hospital

Information Provided By

North Shore Long Island Jewish Health System

Verification Date

May 2013

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

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