Functional MRI-based Assessment of Terlipressin vs. Octreotide on Renal Function in Cirrhotic Patients With Acute Variceal Bleeding (CHESS1903)

Summary

Acute variceal bleeding is one of the critical complications in patients with cirrhosis. Due to remarkable improvements in diagnostic and therapeutic modalities such as vasoactive agents, endoscopic therapy and antibiotics, the overall prognosis has been improved during the past several decades. However, it is still associated with increased mortality that is still around 20% at 6 weeks.

Patients with advanced cirrhosis have an intense overactivity of the endogenous vasoactive systems characterized by arterial hypotension and low peripheral vascular resistance. Severe renal vasoconstriction in consequence of marked arterial vasodilatation in splanchnic circulation triggers the reduction of glomerular filtration rate, and thus induces acute kidney injury (AKI)/hepatorenal syndrome (HRS), which have been further implicated in the increasing mortality in patients with cirrhosis.

Renal functional magnetic resonance imaging (fMRI), a technique considered superior to the most common method used to estimate the glomerular filtration rate, allows for non-invasive, accurate measurements of renal structures and functions in both animals and humans. It has become increasingly prevalent in research and clinical applications. In recent years, renal fMRI has developed rapidly with progress in MRI hardware and emerging post-processing algorithms. Function related imaging markers could be acquired via renal fMRI, encompassing water molecular diffusion, perfusion, and oxygenation. The study will use phase contrast - MR angiography, intravoxel incoherent motion - diffusion weighted imaging (IVIM-DWI) and blood-oxgen-level-dependent (BOLD)-MRI to evaluate renal functional changes after using vasoactive medications in patients with cirrhosis.

The rationale for the use of vasoactive medications, including terlipressin and octreotide, is to produce splanchnic vasoconstriction and reduce portal blood flow and portal pressure, thereby underpinning the application of these vasoactive drugs in the management of cirrhotic patients with acute variceal bleeding. Meanwhile, terlipressin has been recommended as the international first-line pharmacological therapy for the treatment of HRS because terlipressin may improve renal hemodynamics, improve renal function and potentially enable HRS a reversible condition without the need of liver transplantation. However, the renal protection effect of terlipressin vs. octreotide remains unknown. In this study, the investigators aim to conduct a multicenter, single-blind randomized controlled trial to compare the renal protection effect of terlipressin vs. octreotide assessed by fMRI in the management of cirrhotic patients with acute variceal bleeding.

Conditions

• Renal Function Disorder
• Acute Variceal Bleeding

Interventions

DRUG

Terlipressin

Terlipressin should be administrated intravenously while monitoring heart rate and blood pressure daily.

DRUG

Octreotide

Octreotide should be continuously intravenously administrated while monitoring heart rate and blood pressure daily.

Sponsors & Collaborators

• LanZhou University

  collaborator OTHER

• Zhongda Hospital

  collaborator OTHER

• Guangdong Second Provincial General Hospital

  collaborator OTHER

• Xingtai People's Hospital

  collaborator OTHER

• The Third Hospital of Zhenjiang Affiliated Jiangsu University

  collaborator UNKNOWN

• Tianjin Second People's Hospital

  collaborator OTHER

• The Second Hospital of Anhui Medical University

  collaborator OTHER

• The Sixth People's Hospital of Shenyang

  collaborator OTHER

• The Second Affiliated Hospital of Baotou Medical College

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  lead OTHER

Principal Investigators

• Shenghong Ju, MD · Zhongda Hospital

• Xingshun Qi, MD · General Hospital of Shenyang Military Area

• Xiaolong Qi, MD · LanZhou University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-16

Primary Completion

2020-07-15

Completion

2022-10-15

Countries

• China

Study Locations