Bladder Pressure Predicting Renal Failure in Critically Ill Patients as Compared to 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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Key information

Conditions

Acute Heart Failure Acute Kidney Injury Acute Renal Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Staten Island University Hospital

Staten Island, New York, 10305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

BARD® Intra-abdominal Pressure monitor

Device

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

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Jun 1, 2011
Registry last updated: Feb 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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