NCT02789150

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatorenal Syndrome

Interventions

Type	Name	Description
DRUG	Norepinephrine (Levophed)	Titrate norepinephrine to MAP 65-70
DRUG	Norepinephrine (Levophed)	Titrate norepinephrine to MAP 85 or greater

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-01-11
• Completion: 2018-01-11
• First posted: 2016-06-02
• Last updated: 2018-01-16

Locations

1 site across 1 country: United States