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

Completed

• Conditions: Acute Renal Failure; Acute Heart Failure
• Interventions: Device: BARD® Intra-abdominal Pressure monitor

• Registration Number: NCT01363505
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-24
• Study First Submitted QC: 2011-05-31
• Study First Posted: 2011-06-01
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-31
• Last Update Posted: 2014-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute CHF patients	BARD® Intra-abdominal Pressure monitor	Acute CHF patients with BARD Intra-abdominal pressure monitors in ICU

Primary Outcome Measures

Name	Time	Method
High intraabdominal pressure and effect on renal function	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

Name	Time	Method
Effect of diuretics use on intrabdominal pressure	3 days from admission	Early initiation of diuretics in acute heart failure improvement correlating with decreasing IAP measurements.

Trial Locations

Locations (1)

Staten Island University Hospital; 🇺🇸 Staten Island, New York, United States