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出境医 / 临床实验 / Adjunctive Granisetron Therapy in Patients With Sepsis or Septic Shock (GRANTISS)

Adjunctive Granisetron Therapy in Patients With Sepsis or Septic Shock (GRANTISS)

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sepsis Drug: Granisetron Hydrochloride Drug: Placebo（Normal saline） Phase 2

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Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The participants in treatment group receive intravenous granisetron. The participants in control group receive normal saline.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adjunctive Granisetron Therapy in Patients With Sepsis or Septic Shock：A Single-center, Randomized, Controlled, Single-blind Clinical Trial
Actual Study Start Date : April 25, 2019
Actual Primary Completion Date : November 28, 2020
Actual Study Completion Date : December 28, 2020
Arms and Interventions
Arm Intervention/treatment
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.
Other Name: Selective 5-hydroxytryptamine 3 receptor inhibitor
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.
Other Name: 0.9% saline
Outcome Measures
Primary Outcome Measures :
  1. all-cause mortality rate [ Time Frame: 28 days ]
    All-cause mortality rate from the enrollment to the 28th days


Secondary Outcome Measures :
  1. liver function(1) [ Time Frame: Day at 1,2,3,4,5 after randomization ]
    the serum level of Alanine transaminase(ALT)

  2. liver function(2) [ Time Frame: Day at 1,2,3,4,5 after randomization ]
    the serum level of Aspartate transaminase (AST)

  3. liver function(3) [ Time Frame: Day at 1,2,3,4,5 after randomization ]
    the serum level of total bilirubin

  4. liver function(4) [ Time Frame: Day at 1,2,3,4,5 after randomization ]
    the serum level of direct bilirubin

  5. lung function [ Time Frame: Day at 1,2,3,4,5 after randomization ]
    oxygenation index(PaO2/FiO2)，the patients treated with extracorporeal membrane oxygenation will not collect this indicator

  6. kidney function(1) [ Time Frame: Day at 1,2,3,4,5 after randomization ]
    serum level of Creatinine (Cr)

  7. kidney function(2) [ Time Frame: Day at 1,2,3,4,5 after randomization ]
    serum level of blood urea nitrogen(BUN)

  8. kidney function(3) [ Time Frame: Day at 1,2,3,4,5 after randomization ]
    serum level of Cystatin(Cys)

  9. inflammatory response(1) [ Time Frame: Day at 1,3,5 after randomization. ]
    the serum level of interleukin-6(IL-6)

  10. inflammatory response(2） [ Time Frame: Day at 1,3,5 after randomization. ]
    the serum level of C-reactive protein(CRP)

  11. inflammatory response(3） [ Time Frame: Day at 1,3,5 after randomization. ]
    the serum level of superoxide dismutase(SOD)

  12. inflammatory response(4） [ Time Frame: Day at 1,3,5 after randomization. ]
    the serum level of erythrocyte sedimentation rate(ESR)

  13. The level of lactic acid [ Time Frame: Day at 1,2,3,4,5 after randomization ]
    the serum level of lactic acid

  14. immune function(1) [ Time Frame: Day at 1, 3, 5 after randomization for test the the serum level of white blood cell(WBC). ]
    the serum level of white blood cell(WBC)

  15. immune function(2) [ Time Frame: Day at 1, 3, 5 after randomization for test the the serum level of lymphocyte. ]
    the serum level of lymphocyte

  16. immune function(3) [ Time Frame: Day at 1,5 after randomization for test the the serum level of CD4+ Tcell. ]
    the serum level of CD4+ Tcell

  17. immune function(4) [ Time Frame: Day at 1, 5 after randomization for test the the serum level of CD8+Tcell. ]
    the serum level of CD8+Tcell

  18. The level of 5-hydroxytryptamine (5-HT) [ Time Frame: Day at 1,5 after randomization. ]
    The level of plasma 5-HT

  19. Sequential Organ Failure Assessment (SOFA) score [ Time Frame: Day at 1, 3, 5 after randomization ]
    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.

  20. The proportion of patients receiving mechanical ventilation [ Time Frame: 28 days ]
    The proportion of patients receiving mechanical ventilation within 28 days after randomization

  21. The proportion of patients receiving vasoactive drugs [ Time Frame: 28 days ]
    The proportion of patients receiving vasoactive drugs within 28 days after randomization

  22. The proportion of patients receiving renal replacement therapy(CRRT) [ Time Frame: 28 days ]
    The proportion of patients receiving CRRT within 28 days after randomization

  23. The duration of mechanical ventilation [ Time Frame: 28 days ]
    The the duration of mechanical ventilation therapy in hours( This outcome measure is intended only for patients receiving mechanical ventilation)

  24. The duration of vasoactive drugs [ Time Frame: 28 days ]
    The the duration of vasoactive drugs therapy in hours( This outcome measure is intended only for patients receiving vasoactive drugs)

  25. The duration of CRRT [ Time Frame: 28 days ]
    The the duration of CRRT therapy in hours( This outcome measure is intended only for patients receiving CRRT)

  26. ICU length of stay [ Time Frame: 28 days ]
    ICU length of stay


Other Outcome Measures:
  1. Incidence of adverse events [ Time Frame: 28 days ]
    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.

  2. Incidence of serious adverse events [ Time Frame: 28 days ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion Criteria:

  • 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.
Contacts and Locations

Locations
Layout table for location information
China, Guangdong
Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University
Guangzhou, Guangdong, China, 510282
Sponsors and Collaborators
Zhujiang Hospital
Investigators
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Principal Investigator: ping Chang, M.D.PhD Department of Critical Care Medicine of Zhujiang Hospital
Tracking Information
First Submitted Date  ICMJE April 15, 2019
First Posted Date  ICMJE April 23, 2019
Last Update Posted Date January 13, 2021
Actual Study Start Date  ICMJE April 25, 2019
Actual Primary Completion Date November 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2019) 		all-cause mortality rate [ Time Frame: 28 days ]
All-cause mortality rate from the enrollment to the 28th days
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • liver function(1) [ Time Frame: Day at 1,2,3,4,5 after randomization ]
    the serum level of Alanine transaminase(ALT)
  • liver function(2) [ Time Frame: Day at 1,2,3,4,5 after randomization ]
    the serum level of Aspartate transaminase (AST)
  • liver function(3) [ Time Frame: Day at 1,2,3,4,5 after randomization ]
    the serum level of total bilirubin
  • liver function(4) [ Time Frame: Day at 1,2,3,4,5 after randomization ]
    the serum level of direct bilirubin
  • lung function [ Time Frame: Day at 1,2,3,4,5 after randomization ]
    oxygenation index(PaO2/FiO2)，the patients treated with extracorporeal membrane oxygenation will not collect this indicator
  • kidney function(1) [ Time Frame: Day at 1,2,3,4,5 after randomization ]
    serum level of Creatinine (Cr)
  • kidney function(2) [ Time Frame: Day at 1,2,3,4,5 after randomization ]
    serum level of blood urea nitrogen(BUN)
  • kidney function(3) [ Time Frame: Day at 1,2,3,4,5 after randomization ]
    serum level of Cystatin(Cys)
  • inflammatory response(1) [ Time Frame: Day at 1,3,5 after randomization. ]
    the serum level of interleukin-6(IL-6)
  • inflammatory response(2） [ Time Frame: Day at 1,3,5 after randomization. ]
    the serum level of C-reactive protein(CRP)
  • inflammatory response(3） [ Time Frame: Day at 1,3,5 after randomization. ]
    the serum level of superoxide dismutase(SOD)
  • inflammatory response(4） [ Time Frame: Day at 1,3,5 after randomization. ]
    the serum level of erythrocyte sedimentation rate(ESR)
  • The level of lactic acid [ Time Frame: Day at 1,2,3,4,5 after randomization ]
    the serum level of lactic acid
  • immune function(1) [ Time Frame: Day at 1, 3, 5 after randomization for test the the serum level of white blood cell(WBC). ]
    the serum level of white blood cell(WBC)
  • immune function(2) [ Time Frame: Day at 1, 3, 5 after randomization for test the the serum level of lymphocyte. ]
    the serum level of lymphocyte
  • immune function(3) [ Time Frame: Day at 1,5 after randomization for test the the serum level of CD4+ Tcell. ]
    the serum level of CD4+ Tcell
  • immune function(4) [ Time Frame: Day at 1, 5 after randomization for test the the serum level of CD8+Tcell. ]
    the serum level of CD8+Tcell
  • The level of 5-hydroxytryptamine (5-HT) [ Time Frame: Day at 1,5 after randomization. ]
    The level of plasma 5-HT
  • Sequential Organ Failure Assessment (SOFA) score [ Time Frame: Day at 1, 3, 5 after randomization ]
    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.
  • The proportion of patients receiving mechanical ventilation [ Time Frame: 28 days ]
    The proportion of patients receiving mechanical ventilation within 28 days after randomization
  • The proportion of patients receiving vasoactive drugs [ Time Frame: 28 days ]
    The proportion of patients receiving vasoactive drugs within 28 days after randomization
  • The proportion of patients receiving renal replacement therapy(CRRT) [ Time Frame: 28 days ]
    The proportion of patients receiving CRRT within 28 days after randomization
  • The duration of mechanical ventilation [ Time Frame: 28 days ]
    The the duration of mechanical ventilation therapy in hours( This outcome measure is intended only for patients receiving mechanical ventilation)
  • The duration of vasoactive drugs [ Time Frame: 28 days ]
    The the duration of vasoactive drugs therapy in hours( This outcome measure is intended only for patients receiving vasoactive drugs)
  • The duration of CRRT [ Time Frame: 28 days ]
    The the duration of CRRT therapy in hours( This outcome measure is intended only for patients receiving CRRT)
  • ICU length of stay [ Time Frame: 28 days ]
    ICU length of stay
Original Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
  • liver function [ Time Frame: Day at 1,2,3,4,5 after randomization ]
    the serum level of transaminase(AST、ALT)、total bilirubin、direct bilirubin
  • lung function [ Time Frame: Day at 1,2,3,4,5 after randomization ]
    oxygenation index(PaO2/FiO2)，the patients treated with extracorporeal membrane oxygenation will not collect this indicator
  • kidney function [ Time Frame: Day at 1,2,3,4,5 after randomization ]
    serum level of Creatinine (Cr)、blood urea nitrogen(BUN)、Cystatin(Cys)
  • inflammatory response [ Time Frame: Day at 1,3,5 after randomization. ]
    the serum level of IL-6、C-reactive protein、Erythrocyte sedimentation rate(ESR)、Superoxide dismutase(SOD).
  • The level of lactic acid [ Time Frame: Day at 1,2,3,4,5 after randomization ]
    the serum level of lactic acid
  • immune function [ Time Frame: Day at 1, 3, 5 after randomization for test the the serum level of white blood cell(WBC) and lymphocyte，and day at 1,5 after randomization for test the level of CD4+ Tcell、CD8+Tcell. ]
    the serum level of white blood cell(WBC)、lymphocyte、CD4+ Tcell、CD8+Tcell
  • The level of 5-hydroxytryptamine (5-HT) [ Time Frame: Day at 1,5 after randomization. ]
    The level of plasma 5-HT
  • Sequential Organ Failure Assessment (SOFA) score [ Time Frame: Day at 1, 3, 5 after randomization ]
    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.
  • The proportion of patients receiving mechanical ventilation [ Time Frame: 28 days ]
    The proportion of patients receiving mechanical ventilation within 28 days after randomization
  • The proportion of patients receiving vasoactive drugs [ Time Frame: 28 days ]
    The proportion of patients receiving vasoactive drugs within 28 days after randomization
  • The proportion of patients receiving renal replacement therapy(CRRT) [ Time Frame: 28 days ]
    The proportion of patients receiving CRRT within 28 days after randomization
  • The duration of mechanical ventilation [ Time Frame: 28 days ]
    The the duration of mechanical ventilation therapy in hours( This outcome measure is intended only for patients receiving mechanical ventilation)
  • The duration of vasoactive drugs [ Time Frame: 28 days ]
    The the duration of vasoactive drugs therapy in hours( This outcome measure is intended only for patients receiving vasoactive drugs)
  • The duration of CRRT [ Time Frame: 28 days ]
    The the duration of CRRT therapy in hours( This outcome measure is intended only for patients receiving CRRT)
  • ICU length of stay [ Time Frame: 28 days ]
    ICU length of stay
Current Other Pre-specified Outcome Measures
 (submitted: April 22, 2019)
  • Incidence of adverse events [ Time Frame: 28 days ]
    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.
  • Incidence of serious adverse events [ Time Frame: 28 days ]
    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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Adjunctive Granisetron Therapy in Patients With Sepsis or Septic Shock
Official Title  ICMJE Adjunctive Granisetron Therapy in Patients With Sepsis or Septic Shock：A Single-center, Randomized, Controlled, Single-blind Clinical Trial
Brief Summary 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.
Detailed Description

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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The participants in treatment group receive intravenous granisetron. The participants in control group receive normal saline.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sepsis
Intervention  ICMJE
  • 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.
    Other Name: Selective 5-hydroxytryptamine 3 receptor inhibitor
  • 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.
    Other Name: 0.9% saline
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Granisetron Hydrochloride
  • 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.
    Intervention: Drug: Placebo（Normal saline）
Publications *
  • 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.
  • Guan J, Guo Y, Chang P, Gan J, Zhou J, Wang H, Cen Z, Tang Y, Liu Z, Chen P. Adjunctive granisetron therapy in patients with sepsis or septic shock (GRANTISS): Study protocol for a randomized controlled trial. Medicine (Baltimore). 2019 Sep;98(39):e17354. doi: 10.1097/MD.0000000000017354.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2019) 		154
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 28, 2020
Actual Primary Completion Date November 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03924518
Other Study ID Numbers  ICMJE 2018-ZZJHZX-009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: 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.
Responsible Party Zhujiang Hospital
Study Sponsor  ICMJE Zhujiang Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: ping Chang, M.D.PhD Department of Critical Care Medicine of Zhujiang Hospital
PRS Account Zhujiang Hospital
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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