RAI & HRS: Relationship Between Relative Adrenal Insufficiency and Failure of Treatment in Hepatorenal Syndrome

NCT04273750 | Completed

• 1 other identifier: 17/P/152
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Hepatorenal syndrome is a life-threatening medical condition and a serious complication of advanced liver scarring (cirrhosis). It consists of a deterioration of the function of the kidneys caused by a severe alteration in the circulation (blood flow to the kidneys) due to liver cirrhosis. Only around half of the patients respond to treatment which consists of intravenous medication. Moreover, the adrenal glands, which are located on the kidneys, also suffer an alteration in the blood flow leading to deterioration in their function as well. Thus, these patients produced less cortisol than needed; this situation is called "relative adrenal insufficiency". Cortisol is an important hormone necessary in extreme situations such as severe diseases. This is a study which will assess the relationship between the presence of adrenal dysfunction and failure to treatment in patients with hepatorenal syndrome.

Conditions

Liver Cirrhosis; Acute Kidney Injury; Hepato-Renal Syndrome

Outcome Measures

Primary Outcomes (1)

• Response to treatment

  Reduction in sCr with terlipressin in patients with hepatorenal syndrome between patients with and without relative adrenal insufficiency. \*\* Definition of response to treatment: Response to treatment is defined as a reduction of at least 25% from pre-treatment value. Full response is met when final sCr returns to a value lower than 26 µmol/L above the baseline value. Partial response is met when final sCr returns to a value higher than 26 µmol/L above the baseline value. Always with a reduction of sCr of at least 25% from pre-treatment value.

  Between days 5 to 14 after treatment has started

Secondary Outcomes (4)

• Hospital Mortality Rates

  Through study completion an average of 20 months

• Bacterial Translocation

  At baseline

• Degree of Inflammation

  At baseline

• Circulatory Dysfunction

  At baseline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hepatorenal syndrome is a life-threatening medical condition and a serious complication of advanced liver scarring (cirrhosis). It consists of a deterioration in the function of the kidneys caused by a severe alteration in the blood flow to the kidneys due to liver cirrhosis. Around half of patients respond to treatment. The adrenal glands (located on the kidneys), suffer a variation in blood flow leading to deterioration in their function. Thus these patients produce less cortisol than needed; this situation is called "relative adrenal insufficiency". Cortisol is an important hormone necessary in extreme situations such as severe diseases. This study is to assess the relationship between the presence of adrenal dysfunction and failure to treatment in patients with hepatorenal syndrome.

You may qualify if:

• Subjects capable of giving informed consent, or in case of lack of capacity, their legal representative consent on their behalf.
• Older than 18 years old and younger than 80 years old.
• Diagnosis of cirrhosis according to liver biopsy, or non-invasive markers (Fibroscan) or a combination of clinical and imaging criteria.
• Diagnosis of AKI stage 2-3 or stage 1 with serum Creatinine \> 133 µmol/L, according to the last international consensus (International Club of Ascites, 2015)

You may not qualify if:

• Advanced hepatocellular carcinoma, Barcelona-Clinic liver cancer (BCLC) stage C or D
• Infection by human immunodeficiency virus (HIV)
• Previous transplant or any other type of immunodeficiency
• Pregnancy
• Long-term treatment with steroids or other immunosuppressive agents or interferon
• Severe chronic heart failure, New York Heart Association (NYHA), class III or IV
• Advanced COPD, global initiative for chronic obstructive lung disease (GOLD) III or IV
• Renal failure on haemodialysis
• Any medical condition that gives a survival shorter than 3 months

Sponsors & Collaborators

• University Hospital Plymouth NHS Trust: lead

Study Sites (1)

University Hospitals Plymouth NHS Trust

Plymouth, Devon, PL6 8DH, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Plasma renin activity: 0,5 mL of plasma EDTA * Plasma norepinephrine: 1,3 mL of plasma EDTA * Aldosterone: 0,5 mL of serum * TNF-alpha: 0,5 mL of serum * Interleukin-6: 0,3 mL of serum * Interleukin-10: 0,3 mL of serum * Interleukin-12: 0,5 mL of serum * 10 ml of urine will be centrifuged at 3000 rpm for 10 minutes at 4°C and storage specimens at - 80°C.

MeSH Terms

Conditions

Liver Cirrhosis; Acute Kidney Injury; Hepatorenal Syndrome

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Juan Acevedo, MD

  jacevedo@nhs.net

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: February 18, 2020
• Study Start: March 5, 2018
• Primary Completion: February 5, 2020
• Study Completion: February 5, 2020
• Last Updated: February 18, 2020

Record last verified: 2019-08

Locations

GB (1)