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

NCT01363505 | Completed DMC

• 1 other identifier: 11-021
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Heart Failure; Acute Renal Failure

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Effect of diuretics use on intrabdominal pressure

  3 days from admission

Study Arms (1)

Acute CHF patients

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

Device: BARD® Intra-abdominal Pressure monitor

Interventions

BARD® Intra-abdominal Pressure monitor DEVICE

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

Acute CHF patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

Related Publications (3)

• 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.

  PMID: 17377769 BACKGROUND

• 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.

  PMID: 9583702 BACKGROUND

• 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.

  PMID: 16708717 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Suzanne El-Sayegh, MD

  Staten Island University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrology Attending, Assoc. Chair of Medicine

Study Record Dates

• First Submitted: May 24, 2011
• First Posted: June 1, 2011
• Study Start: May 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: February 3, 2014

Record last verified: 2014-01

Locations

US (1)