title: Effects of Shenfu Injection in the Treatment of Septic Shock Patients: A Multicenter, Controlled, Randomized, Open-Label Trial.
abstract: The effect of Shenfu on biochemical parameters and survival during resuscitation in patients with septic shock was examined. This was a multicenter, controlled, randomized, open-label trial carried out in 210 patients with septic shock from seven medical centers in China. They were randomized to Shenfu or saline. The primary outcome was lactate clearance. The secondary outcomes were shock index normalization, dose of vasopressors, ICU stay, hospital stay, and mortality. A total of 199 patients completed the trial. Blood pressure, heart rate, and other routine lab tests showed no difference between the groups. Lactate levels and lactate clearance were similar between the two groups. Hospital and ICU stay were similar between the two groups. When considering all patients, the 7- and 28-day mortality were similar between the two groups, but when considering only patients with lactate levels ≥4.5 mmol/L, the Shenfu group showed a better 7-day survival than the control group (7 days: 83.3% versus 54.5%, P = 0.034; 28 days: 72.7% versus 47.6%, P = 0.092). Shenfu may improve the 7-day survival in patients with impaired lactate clearance (≥4.5 mmol/L), but the mechanism for this effect is unclear. Additional studies are necessary to characterize the hemodynamic changes after Shenfu infusion. This trial is registered with ChiCTR-TRC-11001369.
authors.affiliation: Emergency Department, Peking Union Medical College Hospital, Beijing 100730, China.
authors.forename: Yi
authors.identifier: 0000-0002-9800-9120
authors.initials: Y
authors.lastname: Li
authors.affiliation: Emergency Department, Beijing Hospital of the Ministry of Health, Beijing 100005, China.
authors.forename: Xinchao
authors.initials: X
authors.lastname: Zhang
authors.affiliation: Emergency Department, The First Affiliated Hospital of Fujian Medical University, Fuzhou 350005, China.
authors.forename: Peihong
authors.initials: P
authors.lastname: Lin
authors.affiliation: Emergency Department, Zhongda Hospital, Dongnan University, Nanjing 210009, China.
authors.forename: Haibo
authors.identifier: 0000-0001-8589-4717
authors.initials: H
authors.lastname: Qiu
authors.affiliation: Emergency Department, Hubei Provincial Hospital, Wuhan 430000, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Wei
authors.affiliation: Emergency Department, The First Affiliated Hospital of Huaxi Medical College of Sichuan University, Chengdu 610044, China.
authors.forename: Yu
authors.initials: Y
authors.lastname: Cao
authors.affiliation: Emergency Department, Xinhua Hospital, Shanghai Jiao Tong University, Shanghai 200093, China.
authors.forename: Shuming
authors.initials: S
authors.lastname: Pan
authors.affiliation: Emergency Department, Saint Louis University, Saint Louis, MO 63130, USA.
authors.forename: Joseph
authors.initials: J
authors.lastname: Walline
authors.affiliation: Emergency Department, The First Affiliated Hospital of Kunming Medical University, Kunming 650034, China.
authors.forename: Chuanyun
authors.initials: C
authors.lastname: Qian
authors.affiliation: Emergency Department, PLA 263 Hospital, Beijing 101199, China.
authors.forename: Zhigang
authors.initials: Z
authors.lastname: Shan
authors.affiliation: Emergency Department, Peking Union Medical College Hospital, Beijing 100730, China.
authors.forename: XueZhong
authors.identifier: 0000-0002-2540-7590
authors.initials: X
authors.lastname: Yu