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

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ClinicalTrials.gov Identifier: NCT03924518
Recruitment Status : Recruiting
First Posted : April 23, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Zhujiang Hospital

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

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




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



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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 when entering the intensive care unit (ICU)

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 (Infectious patients requiring special isolation).
  • 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 (such as some intraperitoneal infection etc.)
  • patients allergic to granisetron.
  • patients with intestinal obstruction.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03924518


Contacts
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Contact: zhanguo Liu, M.D.PhD +86-2062782927 zhguoliu@163.com
Contact: ping Chang, M.D.PhD +86-2062782927 changp963@163.com

Locations
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China, Guangdong
Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510282
Contact: ping Chang, PhD         
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

Additional Information:
Publications:
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Responsible Party: Zhujiang Hospital
ClinicalTrials.gov Identifier: NCT03924518     History of Changes
Other Study ID Numbers: 2018-ZZJHZX-009
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhujiang Hospital:
sepsis
septic shock
granisetron

Additional relevant MeSH terms:
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Sepsis
Toxemia
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Granisetron
Serotonin
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Receptor Agonists