A Phase 2 interventional study of Granisetron Hydrochloride and Placebo（Normal saline） in Sepsis, sponsored by Zhujiang Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-07-07.
Sponsored by Zhujiang Hospital · Phase 2, Interventional, and Treatment
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:
Safety endpoints：
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 154 is above the median of 105 across 896 interventional studies indexed under Sepsis.
Browse Sepsis studies →Zhujiang Hospital is the lead sponsor of 199 studies on the registry; 96 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria(Only patients who fully meet the following criteria are eligible to participate in the trial):
Exclusion Criteria:
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
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）
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.
Also known as: Selective 5-hydroxytryptamine 3 receptor inhibitor
therapeutic drug and placebo are identical in appearance, and 50 ml syringes will serve as the containers for all intravenous drugs.
Also known as: 0.9% saline
all-cause mortality rate
All-cause mortality rate from the enrollment to the 28th days
Time frame: 28 days
liver function(1)
the serum level of Alanine transaminase(ALT)
Time frame: Day at 1,2,3,4,5 after randomization
liver function(2)
the serum level of Aspartate transaminase (AST)
Time frame: Day at 1,2,3,4,5 after randomization
liver function(3)
the serum level of total bilirubin
Time frame: Day at 1,2,3,4,5 after randomization
liver function(4)
the serum level of direct bilirubin
Time frame: Day at 1,2,3,4,5 after randomization
lung function
oxygenation index(PaO2/FiO2)，the patients treated with extracorporeal membrane oxygenation will not collect this indicator
Time frame: Day at 1,2,3,4,5 after randomization
kidney function(1)
serum level of Creatinine (Cr)
Time frame: Day at 1,2,3,4,5 after randomization
kidney function(2)
serum level of blood urea nitrogen(BUN)
Time frame: Day at 1,2,3,4,5 after randomization
kidney function(3)
serum level of Cystatin(Cys)
Time frame: Day at 1,2,3,4,5 after randomization
inflammatory response(1)
the serum level of interleukin-6(IL-6)
Time frame: Day at 1,3,5 after randomization.
inflammatory response(2）
the serum level of C-reactive protein(CRP)
Time frame: Day at 1,3,5 after randomization.
inflammatory response(3）
the serum level of superoxide dismutase(SOD)
Time frame: Day at 1,3,5 after randomization.
inflammatory response(4）
the serum level of erythrocyte sedimentation rate(ESR)
Time frame: Day at 1,3,5 after randomization.
The level of lactic acid
the serum level of lactic acid
Time frame: Day at 1,2,3,4,5 after randomization
immune function(1)
the serum level of white blood cell(WBC)
Time frame: Day at 1, 3, 5 after randomization for test the the serum level of white blood cell(WBC).
immune function(2)
the serum level of lymphocyte
Time frame: Day at 1, 3, 5 after randomization for test the the serum level of lymphocyte.
immune function(3)
the serum level of CD4+ Tcell
Time frame: Day at 1,5 after randomization for test the the serum level of CD4+ Tcell.
immune function(4)
the serum level of CD8+Tcell
Time frame: Day at 1, 5 after randomization for test the the serum level of CD8+Tcell.
The level of 5-hydroxytryptamine (5-HT)
The level of plasma 5-HT
Time frame: Day at 1,5 after randomization.
Sequential Organ Failure Assessment (SOFA) score
Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score.SOFA score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems.The highest score for each of the six items is 4 points, and the lowest score is 0 points.Finally, the scores of the six items are summed to get the value of the sofa score.The range of the sofa score is 0-24.Higher values represent a worse outcome.
Time frame: Day at 1, 3, 5 after randomization
The proportion of patients receiving mechanical ventilation
The proportion of patients receiving mechanical ventilation within 28 days after randomization
Time frame: 28 days
The proportion of patients receiving vasoactive drugs
The proportion of patients receiving vasoactive drugs within 28 days after randomization
Time frame: 28 days
The proportion of patients receiving renal replacement therapy(CRRT)
The proportion of patients receiving CRRT within 28 days after randomization
Time frame: 28 days
The duration of mechanical ventilation
The the duration of mechanical ventilation therapy in hours( This outcome measure is intended only for patients receiving mechanical ventilation)
Time frame: 28 days
The duration of vasoactive drugs
The the duration of vasoactive drugs therapy in hours( This outcome measure is intended only for patients receiving vasoactive drugs)
Time frame: 28 days
The duration of CRRT
The the duration of CRRT therapy in hours( This outcome measure is intended only for patients receiving CRRT)
Time frame: 28 days
ICU length of stay
ICU length of stay
Time frame: 28 days
Incidence of adverse events
A adverse event refers to any adverse medical event that occur after the intervention of trial. The adverse events are not necessarily causally related to the trial treatment.
Time frame: 28 days
Incidence of serious adverse events
Any adverse medical event occurs at any dose that meets one or more of the following criteria: 1. causes death 2. life-threatening 3. requires hospitalization or hospitalization for an extended period of time 4. causes permanent or significant disability and functional defects 5. causes deformity
Time frame: 28 days
Plan to share: No — since some data may involve patients privacy ，we have no plans to share data so far，and some data may be shared later depending on the patient's wishes.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Zhujiang Hospital