Clinical trial NCT01363505: Bladder Pressure Predicting Renal Failure in Critically Ill Patients as Compared to Hemodynamic Parameters
Official title: Is Intravesicular Pressure a Better Tool to Predict Renal Failure in Critically Ill Patients Compared With Routine Hemodynamic Parameters?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Heart Failure
Acute Renal Failure
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2011-06-01
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.


Eligibility 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)

Primary outcomes:
measure: High intraabdominal pressure and effect on renal function
timeFrame: from admission (baseline) until 72 hours later
Secondary outcomes:
measure: Effect of diuretics use on intrabdominal pressure
timeFrame: 3 days from admission
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
Study officials:
affiliation: Staten Island University Hospital
name: Suzanne El-Sayegh, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.