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

NCT ID: NCT01363505

Last Updated: 2014-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-04-30

Brief Summary

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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

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Conditions

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Acute Heart Failure Acute Renal Failure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute CHF patients

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

BARD® Intra-abdominal Pressure monitor

Intervention Type DEVICE

monitor linked to foley catheter that is able to measure pressure inside bladder

Interventions

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BARD® Intra-abdominal Pressure monitor

monitor linked to foley catheter that is able to measure pressure inside bladder

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Suzanne El-Sayegh

Nephrology Attending, Assoc. Chair of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suzanne El-Sayegh, MD

Role: STUDY_DIRECTOR

Staten Island University Hospital

Locations

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Staten Island University Hospital

Staten Island, New York, United States

Site Status

Countries

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United States

References

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Cheatham ML, Malbrain ML, Kirkpatrick A, Sugrue M, Parr M, De Waele J, Balogh Z, Leppaniemi A, Olvera C, Ivatury R, D'Amours S, Wendon J, Hillman K, Wilmer A. Results from the International Conference of Experts on Intra-abdominal Hypertension and Abdominal Compartment Syndrome. II. Recommendations. Intensive Care Med. 2007 Jun;33(6):951-62. doi: 10.1007/s00134-007-0592-4. Epub 2007 Mar 22.

Reference Type BACKGROUND
PMID: 17377769 (View on PubMed)

Cheatham ML, Safcsak K. Intraabdominal pressure: a revised method for measurement. J Am Coll Surg. 1998 May;186(5):594-5. doi: 10.1016/s1072-7515(98)00122-7. No abstract available.

Reference Type BACKGROUND
PMID: 9583702 (View on PubMed)

Geisberg C, Butler J. Addressing the challenges of cardiorenal syndrome. Cleve Clin J Med. 2006 May;73(5):485-91. doi: 10.3949/ccjm.73.5.485.

Reference Type BACKGROUND
PMID: 16708717 (View on PubMed)

Other Identifiers

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11-021

Identifier Type: -

Identifier Source: org_study_id

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