Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-01-12 @ 11:12 AM
Study NCT ID:
NCT01363505
Status:
COMPLETED
Last Update Posted:
2014-02-03
First Post:
2011-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bladder Pressure Predicting Renal Failure in Critically Ill Patients as Compared to Hemodynamic Parameters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-31', 'studyFirstSubmitDate': '2011-05-24', 'studyFirstSubmitQcDate': '2011-05-31', 'lastUpdatePostDateStruct': {'date': '2014-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High intraabdominal pressure and effect on renal function', 'timeFrame': 'from admission (baseline) until 72 hours later', 'description': 'IAP measurements will be recorded concomitantly with renal indices. Correlations will be made in regard to pressure measurements and worsening renal function.'}], 'secondaryOutcomes': [{'measure': 'Effect of diuretics use on intrabdominal pressure', 'timeFrame': '3 days from admission', 'description': 'Early initiation of diuretics in acute heart failure improvement correlating with decreasing IAP measurements.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Heart Failure', 'Acute Renal Failure']}, 'referencesModule': {'references': [{'pmid': '17377769', 'type': 'BACKGROUND', '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."}, {'pmid': '9583702', 'type': 'BACKGROUND', '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.'}, {'pmid': '16708717', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'Studies have shown that more than 30% of the overall acute decompensated heart failure (ADHF) patients develop renal dysfunction.\n\nSeveral 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.\n\nResults showed that there were no correlation between baseline hemodynamics or change in hemodynamics and worsening of renal function.\n\nAnother 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any ICU(intensive care unit) or CCU(critical care unit) patient older than 18 y.\n* Patient diagnosed on admission with pulmonary edema/CHF (fluid in the lungs) - independently from the baseline renal function.\n* 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\n\nExclusion Criteria:\n\n* Pregnant women\n* Cognitively impaired patients\n* Age\\<18 yrs old\n* Patients diagnosed on admission with ARDS.\n* Patients admitted with a diagnosis of sepsis ( WBC\\> 12000, CXR findings consistent with pneumonia, positive blood cultures on admission, UTI)'}, 'identificationModule': {'nctId': 'NCT01363505', 'briefTitle': 'Bladder Pressure Predicting Renal Failure in Critically Ill Patients as Compared to Hemodynamic Parameters', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Is Intravesicular Pressure a Better Tool to Predict Renal Failure in Critically Ill Patients Compared With Routine Hemodynamic Parameters?', 'orgStudyIdInfo': {'id': '11-021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute CHF patients', 'description': 'Acute CHF patients with BARD Intra-abdominal pressure monitors in ICU', 'interventionNames': ['Device: BARD® Intra-abdominal Pressure monitor']}], 'interventions': [{'name': 'BARD® Intra-abdominal Pressure monitor', 'type': 'DEVICE', 'description': 'monitor linked to foley catheter that is able to measure pressure inside bladder', 'armGroupLabels': ['Acute CHF patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10305', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Staten Island University Hospital', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}], 'overallOfficials': [{'name': 'Suzanne El-Sayegh, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Staten Island University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nephrology Attending, Assoc. Chair of Medicine', 'investigatorFullName': 'Suzanne El-Sayegh', 'investigatorAffiliation': 'Northwell Health'}}}}