Adjunctive Granisetron Therapy in Patients With Sepsis or Septic Shock

• Status: Completed
• Trial end date: 2020-12-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhujiang Hospital
• Treatments: Granisetron; Serotonin

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.