Adjunctive Granisetron Therapy in Patients With Sepsis or Septic Shock

NCT03924518 | Completed Phase 2 DMC

• 1 other identifier: 2018-ZZJHZX-009
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

sepsis; septic shock; granisetron

Outcome Measures

Primary Outcomes (1)

• all-cause mortality rate

  All-cause mortality rate from the enrollment to the 28th days

  28 days

Secondary Outcomes (26)

• liver function(1)

  Day at 1,2,3,4,5 after randomization

• liver function(2)

  Day at 1,2,3,4,5 after randomization

• liver function(3)

  Day at 1,2,3,4,5 after randomization

• liver function(4)

  Day at 1,2,3,4,5 after randomization

• lung function

  Day at 1,2,3,4,5 after randomization

Other Outcomes (2)

• Incidence of adverse events

  28 days

• Incidence of serious adverse events

  28 days

Study Arms (2)

granisetron group

EXPERIMENTAL

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

placebo group

PLACEBO COMPARATOR

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）

Interventions

Granisetron Hydrochloride DRUG

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

granisetron group

Placebo（Normal saline） DRUG

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

placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University

Guangzhou, Guangdong, 510282, China

Location

Related Publications (2)

• 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.

  PMID: 30506577 BACKGROUND

• 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.

  PMID: 31574878 DERIVED

Related Links

• Our previous research

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Granisetron; Saline Solution

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• ping Chang, M.D.PhD

  Department of Critical Care Medicine of Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The participants in treatment group receive intravenous granisetron. The participants in control group receive normal saline.

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 23, 2019
• Study Start: April 25, 2019
• Primary Completion: November 28, 2020
• Study Completion: December 28, 2020
• Last Updated: July 7, 2022

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)