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
  Purpose

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 Intervention
Acute Heart Failure
Acute Renal Failure
Device: BARD® Intra-abdominal Pressure monitor

Study Type: Observational
Study Design: 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?

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 16
Study Start Date: May 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Other Name: BARD® Intra-abdominal Pressure monitor

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01363505

Locations
United States, New York
Staten Island University Hospital
Staten Island, New York, United States, 10305
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Study Director: Suzanne El-Sayegh, MD Staten Island University Hospital
  More Information

Publications:
Responsible Party: Suzanne El-Sayegh, Nephrology Attending, Assoc. Chair of Medicine, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01363505     History of Changes
Other Study ID Numbers: 11-021
Study First Received: May 24, 2011
Last Updated: January 31, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Critical Illness
Heart Failure
Renal Insufficiency
Acute Kidney Injury
Disease Attributes
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 16, 2014