Overview

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.