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

Acute Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01363505
• Other study ID #: 11-021
• Status: Completed
• Phase: N/A
• First received: May 24, 2011
• Last updated: January 31, 2014
• Start date: May 2011
• Est. completion date: April 2013

Study information

• Verified date: January 2014
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Heart Failure
• Acute Kidney Injury
• Acute Renal Failure
• Critical Illness
• Renal Insufficiency

Intervention

Device:
• BARD® Intra-abdominal Pressure monitor
monitor linked to foley catheter that is able to measure pressure inside bladder

Locations

Country	Name	City	State
United States	Staten Island University Hospital	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (3)

Cheatham ML, Malbrain ML, Kirkpatrick A, Sugrue M, Parr M, De Waele J, Balogh Z, Leppäniemi 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. Epub 2007 Mar 22. — View Citation

Cheatham ML, Safcsak K. Intraabdominal pressure: a revised method for measurement. J Am Coll Surg. 1998 May;186(5):594-5. — View Citation

Geisberg C, Butler J. Addressing the challenges of cardiorenal syndrome. Cleve Clin J Med. 2006 May;73(5):485-91. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High intraabdominal pressure and effect on renal function	IAP measurements will be recorded concomitantly with renal indices. Correlations will be made in regard to pressure measurements and worsening renal function.	from admission (baseline) until 72 hours later	Yes
Secondary	Effect of diuretics use on intrabdominal pressure	Early initiation of diuretics in acute heart failure improvement correlating with decreasing IAP measurements.	3 days from admission	Yes