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Outcomes of Renal Function in Hepatorenal Syndrome (HRS) Determined By Comparison of Target Mean Arterial Pressure (MAP) of 65 - 70 Mmhg Versus ≥ 85 Mmhg

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Descriptive Information
Brief Title † Outcomes of Renal Function in Hepatorenal Syndrome (HRS) Determined By Comparison of Target Mean Arterial Pressure (MAP) of 65 - 70 Mmhg Versus ≥ 85 Mmhg
Official Title † Outcomes of Renal Function in Hepatorenal Syndrome (HRS) Determined By Comparison of Target Mean Arterial Pressure (MAP) of 65 - 70 Mmhg Versus ≥ 85 Mmhg
Brief Summary Comparing renal outcomes based on a Mean Arterail Pressure (MAP) of 65-7085mmhg versus a MAP of greater than or equal to 85mmhg
Detailed Description Main hypothesis: The investigators propose that there will be no difference clinical outcomes as evidenced by a significant difference in urine output or change in creatinine between the MAP target ≥ 85mmhg and the MAP target of 65-70 mmhg. Primary end point: To determine if High MAP or Low MAP will provide the most optimal renal function. The primary endpoints will be 96h UOP and change in creatinine levels. UOP will be calculated as cc/24 hours. The investigators will compare the change in urinary output of day 1 versus day 4. Creatinine will be measured daily and the change from initiation to completion of the study will be recorded. The mean values of these will be compared. Secondary end point: To determine if High MAP or Low MAP will decrease the occurrence of cardiac events (arrhythmias and myocardial infarctions) and vascular events (limb or intestinal ischemia). Study Design: This is a prospective, unblinded, randomized, Two-arm treatment, pilot study. Patients will undergo block randomization to receive either a MAP ≥ 85mmhg or a MAP 65-70mmhg.
Study Phase N/A
Study Type † Interventional
Study Design †
Primary Outcome Measure † Urine output
Secondary Outcome Measure † Cardiac events
Condition † Hepatorenal Syndrome
Intervention † DrugNorepinephrine (Levophed)
Study Arms / Comparison Groups MAP 65-70 Goal MAP of 65-70 MAP greater than or equal to 85 MAP greater than or equal to 85
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 18
Start Date † January 2015
Completion Date December 2017
Primary Completion Date December 2017
Eligibility Criteria † Inclusion Criteria: - 1. Admission to intensive care unit (ICU) 2. Age >18 years old 3. Able to obtain informed consent obtained from the patient, from the patient's power of attorney, or from the next of kin 4. Must meet all major criteria based on the International Ascites Club definition and diagnostic criteria for Hepatorenal Syndrome: 1. chronic or acute liver disease with advanced hepatic failure and portal hypertension; 2. the serum creatinine is greater than 1. 5 mg/dL or 24 hour creatinine clearance of less than 40 ml/min; 3. absence of shock, ongoing bacterial infection, and current or recent treatment with nephrotoxic drugs; 4. absence of gastrointestinal fluid losses (repeated vomiting or intense diarrhea) or renal fluid losses; 5. no sustained improvement in renal function defined as a decrease in serum creatinine to less than 1.5 mg/dL or increase in 24 hour creatinine clearance to 40 ml/min or more following diuretic withdrawal and expansion of plasma volume with 1.5 L of isotonic saline; 6. proteinuria less than 500 mg/dL; 7. no ultrasonic evidence of obstructive uropathy or parenchymal renal disease. 5. In addition, patients must meet the definition of HRS type I or HRS type I 1. -HRS I defined by a rapid deterioration in kidney function with the serum creatinine increasing by more than 100% from baseline to greater than 2.5mg/dl within a two week period. 2. -HRS II defined as: patients with refractory ascites with either a steady but moderate degree of functional renal failure (≥ 1.5mg/dl) or deterioration in kidney function that does not fulfill the criteria for HRS type I Exclusion Criteria: - 1. pre-existing continuous renal replacement therapy cannot or those initiated on dialysis during their hospital stay. 2. artificial liver support therapies 3. ongoing gastrointestinal bleeding 4. active surgical issues 5. pre-existing TIPS or TIPS placed during hospital stay 6. long standing hypertension 7. improvement in renal function after central blood volume expansion contraindications to norepinephrine (active myocardial event, ventricular arrhythmia, obstructive physiology, limb ischemia) 8. Pregnancy 9. Treating physicians refusing to enroll patient
Gender All
Ages 18 Years - 100 Years
Accepts Healthy Volunteers No
Contacts †† Mohamed Saad, MD, 502-852-5841, mohamed.saad@louisville.edu
Location Countries † United States
Administrative Information
NCT ID † NCT02789150
Organization ID 14.1190
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † University of Louisville
Collaborators ††
Investigators † : ,
Information Provided By
Verification Date January 2017
First Received Date † January 28, 2015
Last Updated Date January 26, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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