@article{ATM30507,
author = {Xinwen Yan and Ruoyang Shao and Yuancheng Wang and Xiaorong Mao and Junqiang Lei and Liting Zhang and Jianjun Zheng and Aimin Liu and Huimin Zhao and Fengxiao Gao and Jitao Wang and Ping Li and Shengjuan Yao and Ming Xu and Jian Xu and Dengxiang Liu and Yuqiang Mi and Xijun Gong and Jun Ye and Mingming Deng and Tong Dang and Jiansong Ji and Chuxiao Shao and Chao Liu and Ye Gu and Yunhong Wu and Fengmei Wang and Gaojun Teng and Xun Li and Xingshun Qi and Shenghong Ju and Xiaolong Qi},
title = {Functional magnetic resonance imaging-based assessment of terlipressin vs. octreotide on renal function in cirrhotic patients with acute variceal bleeding (CHESS1903): study protocol of a multicenter randomized controlled trial},
journal = {Annals of Translational Medicine},
volume = {7},
number = {20},
year = {2019},
keywords = {},
abstract = {Background: Acute variceal bleeding is one of the critical complications in patients with liver cirrhosis. Severe renal vasoconstriction in consequence of low peripheral vascular resistance triggers the reduction of glomerular filtration rate (GFR), and thus induces acute kidney injury (AKI)/hepato-renal syndrome (HRS). Terlipressin and octreotide have been used in the management of cirrhotic patients with variceal bleeding. Also, terlipressin has been recommended as the international first-line pharmacological therapy for the treatment of HRS. In addition, the use of renal functional magnetic resonance imaging (fMRI) has become increasingly prevalent in research and clinical applications. However, the renal function-protective effect of terlipressin and octreotide and the value of fMRI in monitoring renal function remains unclear in patients with cirrhosis undergoing acute variceal bleeding.
Methods: This is a multicenter, randomized controlled trial (RCT). Participants will be 1:1 assigned randomly into either terlipressin or octreotide groups. Sixty participants with clinically and/or pathologically diagnosed cirrhosis and active gastroesophageal variceal bleeding (GVB) will be recruited in several sites in China. Participants will receive either the treatment of terlipressin or octreotide after assigned into each group. The primary end point for the trial is the renal function. The secondary end points are (I) renal perfusion; (II) renal blood oxygenation; (III) failure to control bleeding; (IV) intra-hospital rebleeding; (V) intra-hospital mortality; (VI) adverse events (AE); (VII) overall survival. Statistical analysis including multivariate Cox regression, Kaplan-Meier analysis with log-rank test, etc. will be conducted.
Discussion: The study will provide new insight into the protection of renal function in the process of the treatment of variceal bleeding in patients with cirrhosis.
Trial registration number: NCT04028323.},
issn = {2305-5847}, url = {https://atm.amegroups.org/article/view/30507}
}