Adjunctive Granisetron Therapy in Patients With Sepsis or Septic Shock：A Single-center, Randomized, Controlled, Single-blind Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- all-cause mortality rate
研究概览
简要总结
In this prospective, single-center,randomized,controlled,single-blind clinical trial,Patients will be randomly assigned to receive granisetron or placebo for 4 days or until leaving the ICU(death or transfer from ICU to general ward or discharge). The primary outcome is all-cause death rate at 28 days.
详细描述
Investigational drug：Granisetron hydrochloride for injection
Study title：Adjunctive Granisetron Therapy in Patients with Sepsis or Septic Shock:A Single-center,Randomized,Controlled,Single-blind Clinical trial.
Principal Investigator：Professor Ping Chang ,Professor Zhanguo Liu, professor Peng Chen,Department of Critical Care Unit, Zhujiang Hospital, Southern Medical University
Study subjects：Adult septic/septic shock patients with procalcitonin(PCT≥2ng/ml when entering the ICU.
Study phase： Investigator Initiated Trial(IIT)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Age<18 years, or age>80 years.
- •Pregnancy or lactating
- •A solid-organ or bone marrow transplant patients.
- •Patients with myocardial infarction within the past 3 months.
- •Advanced pulmonary fibrosis .
- •Patients with cardiopulmonary resuscitation before enrollment.
- •HIV-positive patients.
- •granulocyte-deficient patients.
- •blood/lymphatic system tumors are not remission.
- •patients with limited care (lack of commitment to full，aggressive life support).
- •patients with long-term use of immunosuppressive drugs or with immunodeficiency.
- •patients with advanced tumors.
- •patients combined with non-infectious factors leading to the death(uncontrollable major bleeding, brain hernia, etc.).
- •surgically unresolved infection sources(such as some intraperitoneal infection etc.)
- •patients allergic to granisetron.
- •patients with intestinal obstruction.
研究组 & 干预措施
granisetron group
3ml granisetron（3mg） will be diluted in 22 mL of 0.9% normal saline,and the granisetron diluted will be intravenously injected for at 10 minutes， every 8 hours for 4 days or until leaving the ICU(death or transfer from ICU to general ward or discharge), whichever come first.
干预措施: Granisetron Hydrochloride (Drug)
placebo group
Normal saline 25ml every 8h for 4 days or until leaving the ICU(death or transfer from ICU to general ward or discharge), whichever come first.
干预措施: Placebo（Normal saline） (Drug)
结局指标
主要结局
all-cause mortality rate
时间窗: 28 days
All-cause mortality rate from the enrollment to the 28th days
次要结局
- liver function(1)(Day at 1,2,3,4,5 after randomization)
- liver function(3)(Day at 1,2,3,4,5 after randomization)
- kidney function(1)(Day at 1,2,3,4,5 after randomization)
- The level of 5-hydroxytryptamine (5-HT)(Day at 1,5 after randomization.)
- The proportion of patients receiving mechanical ventilation(28 days)
- The duration of mechanical ventilation(28 days)
- lung function(Day at 1,2,3,4,5 after randomization)
- kidney function(3)(Day at 1,2,3,4,5 after randomization)
- inflammatory response(4）(Day at 1,3,5 after randomization.)
- inflammatory response(3）(Day at 1,3,5 after randomization.)
- The level of lactic acid(Day at 1,2,3,4,5 after randomization)
- ICU length of stay(28 days)
- liver function(2)(Day at 1,2,3,4,5 after randomization)
- liver function(4)(Day at 1,2,3,4,5 after randomization)
- kidney function(2)(Day at 1,2,3,4,5 after randomization)
- inflammatory response(1)(Day at 1,3,5 after randomization.)
- immune function(3)(Day at 1,5 after randomization for test the the serum level of CD4+ Tcell.)
- immune function(4)(Day at 1, 5 after randomization for test the the serum level of CD8+Tcell.)
- The proportion of patients receiving vasoactive drugs(28 days)
- The proportion of patients receiving renal replacement therapy(CRRT)(28 days)
- The duration of CRRT(28 days)
- inflammatory response(2）(Day at 1,3,5 after randomization.)
- immune function(1)(Day at 1, 3, 5 after randomization for test the the serum level of white blood cell(WBC).)
- immune function(2)(Day at 1, 3, 5 after randomization for test the the serum level of lymphocyte.)
- The duration of vasoactive drugs(28 days)
- Sequential Organ Failure Assessment (SOFA) score(Day at 1, 3, 5 after randomization)