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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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ClinicalTrials.gov Identifier: NCT02789150
Recruitment Status : Completed
First Posted : June 2, 2016
Last Update Posted : January 15, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment Phase
Hepatorenal Syndrome Drug: Norepinephrine (Levophed) Early Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2015
Primary Completion Date : January 11, 2018
Study Completion Date : January 11, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: MAP 65-70
Goal MAP of 65-70
Drug: Norepinephrine (Levophed)
Titrate norepinephrine to MAP 65-70
Active Comparator: MAP greater than or equal to 85
MAP greater than or equal to 85
Drug: Norepinephrine (Levophed)
Titrate norepinephrine to MAP 85 or greater


Outcome Measures

Primary Outcome Measures :
  1. Urine output [ Time Frame: 2 years ]
    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. We 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.

  2. serum creatinine [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Cardiac events [ Time Frame: 2 years ]
    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).

  2. ischemic events [ Time Frame: 2 years ]
    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).


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02789150


Locations
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
More Information

Responsible Party: Mohamed Saad, Associate professor of medicine, University of Louisville
ClinicalTrials.gov Identifier: NCT02789150     History of Changes
Other Study ID Numbers: 14.1190
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: January 15, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Syndrome
Hepatorenal Syndrome
Disease
Pathologic Processes
Liver Diseases
Digestive System Diseases
Kidney Diseases
Urologic Diseases
Norepinephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents