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Intensive Care Med. 2018 Nov;44(11):1816-1825. doi: 10.1007/s00134-018-5267-9. Epub 2018 Jul 3.

Terlipressin versus norepinephrine as infusion in patients with septic shock: a multicentre, randomised, double-blinded trial.

Author information

1
Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-sen University, 58 Zhongshan 2nd Road, Guangzhou, 510080, China.
2
Department of Critical Care Medicine, The Sixth Affiliated Hospital of Sun Yat-sen University, 26 Yuancun Erheng Road, Guangzhou, 510080, China.
3
Department of Critical Care Medicine, Qingyuan People's Hospital, The Sixth Affiliated Hospital of Guangzhou Medical University, 24 Yinquan Road, Qingyuan, 511500, Guangdong, China.
4
Department of Critical Care Medicine, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, 32 West Second Section First Ring Road, Chengdu, Sichuan, 610000, China.
5
Department of Critical Care Medicine, The First Affiliated Hospital, GuangXi Medical University, 6 Shuangyong Road, Nanning, 530021, Guangxi, China.
6
Department of Critical Care Medicine, West China Hospital, Sichuan University, 37 Guo Xue Xiang, Chengdu, 610041, Sichuan, China.
7
Department of Critical Care Medicine, Chinese PLA 302 Hospital, 100 Xisihuan Middle Road, Beijing, 100000, China.
8
Department of Critical Care Medicine, Foshan First Municipal People's Hospital, 81 Lingnan North Road, Foshan, 528000, Guangdong, China.
9
Department of Critical Care Medicine, Chinese PLA General Hospital, 28 Fuxing Road, Beijing, 100000, China.
10
Department of Critical Care Medicine, The First Affiliated Hospital, Zhengzhou University, 1 Jianshe East Road, Zhengzhou, 450000, Henan, China.
11
Department of Critical Care Medicine, Zhuhai People's Hospital, 79 Kangning Road, Zhuhai, 519000, Guangdong, China.
12
Department of Critical Care Medicine, The First Affiliated Hospital, Xi An JiaoTong University, 277 Yanta West Road, Xi an, 710000, Shanxi, China.
13
Department of Critical Care Medicine, The First Affiliated Hospital, Bengbu Medical College, 287 Changhuai Road, Bengbu, 233000, Henan, China.
14
Department of Critical Care Medicine, Shandong Provincial Hospital, 324 Jingwuweiqi Road, Jinan, 250000, Shandong, China.
15
Department of Critical Care Medicine, The Third Affiliated Hospital of Sun Yat-sen University, 600 TianHe Road, Guangzhou, 510080, China.
16
Department of Critical Care Medicine, Fujian Provincial Hospital, 134 East Street Fuzhou, Fujian, 350000, China.
17
Department of Critical Care Medicine, Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 127 Jiefangda Road Wuhan, Hubei, 430000, China.
18
Department of Critical Care Medicine, The Affiliated Drum Tower Hospital of Nanjing University Medical School, 321 Zhongshan Road, Nanjing, 210000, Jiangsu Province, China.
19
Department of Critical Care Medicine, The First Affiliated Hospital, Nanchang University, 17 Yongwaizheng Road, Nanchang, 330006, Jiangxi, China.
20
Department of Critical Care Medicine, Guizhou Provincial Hospital, 97 Boai Road, Guiyang, 550002, Guizhou, China.
21
Department of Critical Care Medicine, The Second People's Hospital of Shenzhen, Sungang Road, Shenzhen, 518000, Guangdong, China.
22
School of Public Health, Sun Yat-sen University, 74 Zhongshan 2nd Road, Guangzhou, 510080, China.
23
Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-sen University, 58 Zhongshan 2nd Road, Guangzhou, 510080, China. guanxiangdong1962@163.com.

Abstract

PURPOSE:

Recent clinical data suggest that terlipressin, a vasopressin analogue, may be more beneficial in septic shock patients than catecholamines. However, terlipressin's effect on mortality is unknown. We set out to ascertain the efficacy and safety of continuous terlipressin infusion compared with norepinephrine (NE) in patients with septic shock.

METHODS:

In this multicentre, randomised, double-blinded trial, patients with septic shock recruited from 21 intensive care units in 11 provinces of China were randomised (1:1) to receive either terlipressin (20-160 µg/h with maximum infusion rate of 4 mg/day) or NE (4-30 µg/min) before open-label vasopressors. The primary endpoint was mortality 28 days after the start of infusion. Primary efficacy endpoint analysis and safety analysis were performed on the data from a modified intention-to-treat population.

RESULTS:

Between 1 January 2013 and 28 February 2016, 617 patients were randomised (312 to the terlipressin group, 305 to the NE group). The modified intention-to-treat population comprised 526 (85.3%) patients (260 in the terlipressin group and 266 in the NE group). There was no significant difference in 28-day mortality rate between the terlipressin group (40%) and the NE group (38%) (odds ratio 0.93 [95% CI 0.55-1.56]; p = 0.80). Change in SOFA score on day 7 was similar between the two groups: - 7 (IQR - 11 to 3) in the terlipressin group and - 6 (IQR - 10 to 5) in the NE group. There was no difference between the groups in the number of days alive and free of vasopressors. Overall, serious adverse events were more common in the terlipressin group than in the NE group (30% vs 12%; p < 0.001).

CONCLUSIONS:

In this multicentre, randomised, double-blinded trial, we observed no difference in mortality between terlipressin and NE infusion in patients with septic shock. Patients in the terlipressin group had a higher number of serious adverse events.

TRIAL REGISTRATION:

This trial is registered at ClinicalTrials.gov: ID NCT01697410.

KEYWORDS:

Norepinephrine; SOFA score; Septic shock; Terlipressin

PMID:
29971593
DOI:
10.1007/s00134-018-5267-9

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