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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03924518
Recruitment Status Recruiting
First Posted April 23, 2019
Last update posted August 20, 2019
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.
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) Study objectives：The objective of the study is to determine whether granisetron, compared to placebo, improve the prognosis of sepsis or septic shock,including the reduction in mortality, the protection of organ function and reduction of inflammatory response,and to determine the safety of granisetron in patients with sepsis. Study design：A Single-center,Randomized,Controlled,Single-blind Clinical trial. Medication method： Granisetron treatment group： Follow the guidelines for sepsis in 2016 and recommend routine treatment + 3mg granisetron in 22 ml normal saline every 8 h for 4 days or until leaving the ICU(death or transfer from ICU to general ward or discharge), whichever come first. Placebo control group：Follow the guidelines for sepsis in 2016 and recommend routine treatment + 25ml normal saline every 8 h for 4 days or until leaving the ICU(death or transfer from ICU to general ward or discharge), whichever come first. Course：4days Sample size：154. Sites：1 Primary endpoint：all-cause death at 28 days Secondary endpoints: 1. The state of liver function: the serum level of transaminase(AST、ALT)、total bilirubin、direct bilirubin at 1,2,3,4,5 days after randomization 2. The state of lung function:oxygenation index(PaO2/FiO2) at 1,2,3,4,5 days after randomization (the patients treated with extracorporeal membrane oxygenation will not collect this indicator). 3. The state of kidney function:serum level of Creatinine (Cr)、blood urea nitrogen(BUN)、Cystatin(Cys) at 1,2,3,4,5 days after randomization 4. The state of inflammatory response:the serum level of interleukin-6(IL-6) 、C-reactive protein 、Superoxide dismutase(SOD) and erythrocyte sedimentation rate(ESR) at 1,3,5 days after randomization. 5. The state of circulation system: the serum level of lactic acid at 1,2,3,4,5 days after randomization 6. The state of immune function:the serum level of white blood cell(WBC)、lymphocyte at 1, 3, 5 days after randomization,the serum level of cluster of differentiation 4 Tcell(CD4+ Tcell) and cluster of differentiation 8 Tcell(CD8+ Tcell) at 1,5days after randomization. 7. The level of plasma 5-hydroxytryptamine(5-HT) at 1,5 days after randomization. 8. Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score at 1, 3, 5 after randomization 9. Incidence and duration of supportive care for organ dysfunction including vasoactive agents, mechanical ventilation, continuous renal replacement therapy(CRRT)、daily condition of fuid balance 10. The length of stay in ICU Safety endpoints： 1. adverse events 2. Serious adverse events
|Experimental: 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.
Drug: Granisetron Hydrochloride
Granisetron will be diluted with 0.9% saline to ensure that the therapeutic drug and placebo are identical in appearance, and 50 ml syringes will serve as the containers for all intravenous drugs.
|Placebo Comparator: 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.
Drug: Placebo（Normal saline）
therapeutic drug and placebo are identical in appearance, and 50 ml syringes will serve as the containers for all intravenous drugs.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
Inclusion Criteria(Only patients who fully meet the following criteria are eligible to
participate in the trial):
- Meets the diagnostic criteria for sepsis-3 developed by the American Society of
Critical Care Medicine (SCCM)/European Critical Care Medicine Association (ESICM)
- Age ≥18 years old and age ≤80years old.
- Procalcitonin ≥2ng/ml
- 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.
Contact: zhanguo Liu, M.D.PhD +86-2062782927 email@example.com
Contact: ping Chang, M.D.PhD +86-2062782927 firstname.lastname@example.org
Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University
Principal Investigator: ping Chang, M.D.PhD Department of Critical Care Medicine of Zhujiang Hospital
Gong S, Yan Z, Liu Z, Niu M, Fang H, Li N, Huang C, Li L, Chen G, Luo H, Chen X, Zhou H, Hu J, Yang W, Huang Q, Schnabl B, Chang P, Billiar TR, Jiang Y, Chen P. Intestinal Microbiota Mediates the Susceptibility to Polymicrobial Sepsis-Induced Liver Injury by Granisetron Generation in Mice. Hepatology. 2019 Apr;69(4):1751-1767. doi: 10.1002/hep.30361. Epub 2019 Mar 5.