NCT04028323

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

Status unknown Phase 4 Last updated 17 August 2021

What this trial tests

Phase 4 trial testing Terlipressin in Renal Function Disorder in 60 participants. Status unknown.

Timeline

16 July 2019

Primary endpoint
15 July 2020

15 October 2022

Quick facts

Lead sponsor	Nanfang Hospital, Southern Medical University
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	60
Start date	16 July 2019
Primary completion	15 July 2020
Estimated completion	15 October 2022
Sites	10 locations across China

Drugs / interventions tested

• Terlipressin — full drug profile →
• Octreotide (OCTREOTIDE) — full drug profile →

Conditions studied

• Renal Function Disorder — all drugs for Renal Function Disorder →
• Acute Variceal Bleeding — all drugs for Acute Variceal Bleeding →

Sponsor

Nanfang Hospital, Southern Medical University

Who can join

Adults 18 to 70, any sex, with Renal Function Disorder or Acute Variceal Bleeding. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Functional magnetic resonance imaging-based assessment of terlipressin <i>vs.</i> octreotide on renal function in cirrhotic patients with acute variceal bleeding (CHESS1903): study protocol of a multicenter randomized controlled trial.
   Yan X, Shao R, Wang Y, Mao X, et al · · 2019 · cited 3× · PMID 31807567 · DOI 10.21037/atm.2019.09.141