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

NCT02789150 | Completed Early Phase 1

• 1 other identifier: 14.1190
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Hepatorenal Syndrome

Outcome Measures

Primary Outcomes (2)

• Urine output

  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 years

• serum creatinine

  2 years

Secondary Outcomes (2)

• Cardiac events

  2 years

• ischemic events

  2 years

Study Arms (2)

MAP 65-70

EXPERIMENTAL

Goal MAP of 65-70

Drug: Norepinephrine (Levophed)

MAP greater than or equal to 85

ACTIVE COMPARATOR

MAP greater than or equal to 85

Drug: Norepinephrine (Levophed)

Interventions

Norepinephrine (Levophed) DRUG

Titrate norepinephrine to MAP 65-70

MAP 65-70

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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:
• chronic or acute liver disease with advanced hepatic failure and portal hypertension;
• the serum creatinine is greater than 1. 5 mg/dL or 24 hour creatinine clearance of less than 40 ml/min;
• absence of shock, ongoing bacterial infection, and current or recent treatment with nephrotoxic drugs;
• absence of gastrointestinal fluid losses (repeated vomiting or intense diarrhea) or renal fluid losses;
• 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;
• proteinuria less than 500 mg/dL;
• 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
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• 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.
• 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

You may not qualify if:

• \. pre-existing continuous renal replacement therapy cannot or those initiated on dialysis during their hospital stay.
• \. 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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Related Publications (1)

• Varajic B, Cavallazzi R, Mann J, Furmanek S, Guardiola J, Saad M. 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.

  PMID: 31096099 DERIVED

MeSH Terms

Conditions

Hepatorenal Syndrome

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of medicine

Study Record Dates

• First Submitted: January 28, 2015
• First Posted: June 2, 2016
• Study Start: January 1, 2015
• Primary Completion: January 11, 2018
• Study Completion: January 11, 2018
• Last Updated: January 16, 2018

Record last verified: 2018-01

Locations

US (1)