Study protocol

BL Bing Li
JC Jie Chen
CZ Chun-Qing Zhang
GW Guang-Chuan Wang
JH Jin-Hua Hu
JL Jian-Jun Luo
WZ Wen Zhang
YW Yi-Chao Wei
XZ Xiao-Qing Zeng
SC Shi-Yao Chen
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The random table method was used for randomization, and sealed opaque envelopes were used for the allocation. Baseline HVPG, heart rate (HR), and mean arterial pressure (MAP) measurements of patients who met the inclusion criteria were recorded before vasoactive drug administration. MAP = diastolic blood pressure + (systolic blood pressure − diastolic blood pressure)/3 (12). The vasoactive drugs used in the study were terlipressin (Hybio, Shenzhen, China) and octreotide (Novartis, Basel, Switzerland). After baseline measurements, patients were randomly assigned into two groups: the terlipressin group (n=46) and the high-dose octreotide group (n=42). The patients in the terlipressin group received an intravenous injection of 2 mg terlipressin, while those in the high-dose octreotide group received an initial intravenous injection of 100 µg octreotide followed by continuous intravenous infusion of 50 µg/h. HVPG, HR, and MAP were originally recorded at 10, 20 min after the start of drug administration. Since the differences in HVPG between the two groups were not obvious until 20 min and no further reduction in HVPG was found after 30 min, we decided to prolong the observation time to 30 min. The patients were observed for adverse drug events for 24 hours. The primary endpoint was the change in HVPG. The secondary endpoints were the changes in HR and MAP, hemodynamic responses, and the incidence of adverse events. Hemodynamic responses were defined as HVPG having decreased more than 20% from baseline or below 12 mmHg after drug administration at the time point (7).

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