High versus low mean arterial pressures in hepatorenal syndrome: A randomized controlled pilot trial

J Crit Care. 2019 Aug:52:186-192. doi: 10.1016/j.jcrc.2019.04.006. Epub 2019 Apr 15.

Abstract

There is controversy regarding the mean arterial pressure (MAP) goals that should be targeted in the treatment of hepatorenal syndrome (HRS.) We conducted a study to assess different MAP targets in HRS in the intensive care unit (ICU).

Materials and methods: This is a prospective randomized controlled pilot trial. ICU patients had target mean arterial pressure (MAP) ≥ 85 mmHg (control arm) or 65-70 mmHg (study arm). Urine output and serum creatinine were trended and recorded.

Results: A total of 18 patients were enrolled. The day four urine output in the high and low MAP group was 1194 (SD = 1249) mL/24 h and 920 (SD = 812) mL/24 h, respectively. The difference in day four - day one urine output was -689 (SD = 1684) mL/24 h and 272 (SD = 582) mL/24 h for the high and low MAP groups. The difference in serum creatinine at day four - day one was -0.54 (SD = 0.63) mg/dL and - 0.77 (SD = 1.14) mg/dL in the high and low MAP groups, respectively.

Conclusion: In this study, we failed to prove non-inferiority between a low and high target MAP in patients with HRS.

Trial registration: This trial was registered with and approved by the University of Louisville Internal Review Board and hospital research review committees (IRB # 14.1190). The trial was registered with ClinicalTrials.gov (ID # NCT02789150). The IRB committee roster 7/21/2014-2/26/2015 is registered with IORG (IORG # IORG0000147; OMB # 0990-0279) and is available at http://louisville.edu/research/humansubjects/about-the-irb/rosters/RosterEffective20140721thru20150226.pdf.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Arterial Pressure / physiology
  • Creatinine / blood
  • Critical Care
  • Female
  • Hepatorenal Syndrome / physiopathology*
  • Humans
  • Hypertension / physiopathology*
  • Hypotension / physiopathology*
  • Intensive Care Units
  • Male
  • Middle Aged
  • Pilot Projects
  • Prospective Studies

Substances

  • Creatinine

Associated data

  • ClinicalTrials.gov/NCT02789150