ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02789150
Recruitment Status : Completed
First Posted : June 2, 2016
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed Saad, University of Louisville

January 28, 2015
June 2, 2016
January 16, 2018
January 2015
January 11, 2018   (Final data collection date for primary outcome measure)
  • 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.
  • serum creatinine [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT02789150 on ClinicalTrials.gov Archive Site
  • 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).
  • 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).
Same as current
Not Provided
Not Provided
 
Outcomes of Renal Function in Hepatorenal Syndrome (HRS) Determined By Comparison of Target Mean Arterial Pressure (MAP) of 65 - 70 Mmhg Versus ≥ 85 Mmhg
Outcomes of Renal Function in Hepatorenal Syndrome (HRS) Determined By Comparison of Target Mean Arterial Pressure (MAP) of 65 - 70 Mmhg Versus ≥ 85 Mmhg
Comparing renal outcomes based on a Mean Arterail Pressure (MAP) of 65-7085mmhg versus a MAP of greater than or equal to 85mmhg

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.

Interventional
Early Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hepatorenal Syndrome
  • Drug: Norepinephrine (Levophed)
    Titrate norepinephrine to MAP 65-70
  • Drug: Norepinephrine (Levophed)
    Titrate norepinephrine to MAP 85 or greater
  • Experimental: MAP 65-70
    Goal MAP of 65-70
    Intervention: Drug: Norepinephrine (Levophed)
  • Active Comparator: MAP greater than or equal to 85
    MAP greater than or equal to 85
    Intervention: Drug: Norepinephrine (Levophed)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
Same as current
January 11, 2018
January 11, 2018   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years to 100 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02789150
14.1190
No
Not Provided
Not Provided
Mohamed Saad, University of Louisville
University of Louisville
Not Provided
Not Provided
University of Louisville
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP