1.Effect of early continuous renal replacement therapy on patients with severe sepsis
Qinhan LIN ; Ming ZHANG ; Jun CHEN ; Haibo ZHOU ; Guodong HUANG
Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care 2014;(1):46-49
Objective To evaluate the effect of early continuous renal replacement therapy(CRRT)on patients with acute kidney injury(AKI)induced by severe sepsis. Methods A prospective study was conducted. 160 patients with AKI induced by severe sepsis admitted to intensive care unit(ICU)of Qingyuan People's Hospital between October 2009 and June 2013 were enrolled. According to the starting time of CRRT,the patients were randomly divided into two groups:an earl y treatment group and a regular treatment group(each,80 cases). All patients were treated in accordance with the principle of the cluster of severe sepsis. In early treatment group,the patents began to receive CRRT when the amount of urine output was<0.5 mL?kg-1?h-1 and had taken continuous conventional treatment over 6 hours,but the curative effect was not ideal. In the regular treatment group,the patients began to apply CRRT when the amount of urine output was<0.5 mL?kg-1?h-1 and had taken continuous conventional treatment persistently over 24 hours or difficultly corrected acidosis or heart failure developed. The changes in urine output,creatinine,saturation of blood oxygen,and albumin,and 28-day survival rate,length of ICU stay,time of organ support were measured and compared between the two groups to evaluate the therapeutic significance of the early CRRT. Results The mean length of ICU stay(day:6.5±1.7 vs. 8.2±1.6),length of organ support(day:5.3±1.8 vs. 6.0±1.4),the recovery time of urine amount(day:3.4±0.9 vs. 4.8±0.5)in early treatment group were significantly shorter than those in regular treatment group(all P<0.01);recovery ratio of urine in 1 week in early treatment group was significantly higher than that in regular treatment group(46.2%vs. 28.8%,P<0.05). The creatinine recovery ratio in 1 week in early treatment group was lower than that in regular treatment group(55.0%vs 78.8%),but there was no statistically significant difference(P>0.05). Early treatment group and regular treatment groups of creatinine recovery time were similar(day:5.1±1.3 vs. 5.2±1.2). 28-day survival rate in early treatment group was higher than that in regular treatment group(41.2%vs. 35.0%),but there was no statistically significant difference(P>0.05). Conclusion It is found that there is no evidence to suggest that early CRRT may improve the prognosis of the patients with AKI induced by severe sepsis,but it may be in favor of shortening the time of urine recovery,length of stay in ICU,length of organ support and length of dialysis.
2.Safety and efficacy of ciprofol vs. propofol for sedation in intensive care unit patients with mechanical ventilation: a multi-center, open label, randomized, phase 2 trial
Yongjun LIU ; Xiangyou YU ; Duming ZHU ; Jun ZENG ; Qinhan LIN ; Bin ZANG ; Chuanxi CHEN ; Ning LIU ; Xiao LIU ; Wei GAO ; Xiangdong GUAN
Chinese Medical Journal 2022;135(9):1043-1051
Background::Ciprofol (HSK3486; Haisco Pharmaceutical Group Co., Ltd., Chengdu, China), developed as a novel 2,6-disubstituted phenol derivative showed similar tolerability and efficacy characteristics as propofol when applicated as continuous intravenous infusion for 12 h maintenance sedation in a previous phase 1 trial. The phase 2 trial was designed to investigate the safety, efficacy, and pharmacokinetic characteristics of ciprofol for sedation of patients undergoing mechanical ventilation.Methods::In this multicenter, open label, randomized, propofol positive-controlled, phase 2 trial, 39 Chinese intensive care unit patients receiving mechanical ventilation were enrolled and randomly assigned to a ciprofol or propofol group in a 2:1 ratio. The ciprofol infusion was started with a loading infusion of 0.1-0.2 mg/kg for 0.5-5.0 min, followed by an initial maintenance infusion rate of 0.30 mg·kg -1·h -1, which could be adjusted to an infusion rate of 0.06 to 0.80 mg·kg -1·h -1, whereas for propofol the loading infusion dose was 0.5-1.0 mg/kg for 0.5-5.0 min, followed by an initial maintenance infusion rate of 1.50 mg·kg -1·h -1, which could be adjusted to 0.30-4.00 mg·kg -1·h -1 to achieve -2 to +1 Richmond Agitation-Sedation Scale sedation within 6-24 h of drug administration. Results::Of the 39 enrolled patients, 36 completed the trial. The median (min, max) of the average time to sedation compliance values for ciprofol and propofol were 60.0 (52.6, 60.0) min and 60.0 (55.2, 60.0) min, with median difference of 0.00 (95% confidence interval: 0.00, 0.00). In total, 29 (74.4%) patients comprising 18 (69.2%) in the ciprofol and 11 (84.6%) in the propofol group experienced 86 treatment emergent adverse events (TEAEs), the majority being of severity grade 1 or 2. Drug- and sedation-related TEAEs were hypotension (7.7% vs. 23.1%, P = 0.310) and sinus bradycardia (3.8% vs. 7.7%, P = 1.000) in the ciprofol and propofol groups, respectively. The plasma concentration-time curves for ciprofol and propofol were similar. Conclusions::ciprofol is comparable to propofol with good tolerance and efficacy for sedation of Chinese intensive care unit patients undergoing mechanical ventilation in the present study setting.Trial registration::ClinicalTrials.gov, NCT04147416.