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Effectiveness of Anisodamine Hydrobromide Combined With Heparin for the Treatment of Critically Ill Patients With Septic Shock

Primary Purpose

Septic Shock

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Anisodamine hydrobromide
Heparin
Anisodamine hydrobromide combined with heparin
Sponsored by
Chen Ying
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with septic shock Exclusion Criteria: The age of <18 years or >80 years; Patients who were expected to die within 24h before enrollment; Patients who died or withdrew from the experiment due to serious diseases of heart, liver, kidney and other organs or mental diseases before reaching the end of the intervention effect; Patients had received treatment related to septic shock before enrollment, which may affect the observers of effect indicators; patients contraindicated with heparin and anisodamine; Refuse to sign the informed consent; Patients with thrombotic diseases requiring low molecular weight heparin treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    No Intervention

    Arm Label

    anisodamine hydrobromide

    heparin

    Anisodamine hydrobromide combined with heparin

    conventional therapy

    Arm Description

    The dosage of anisodamine hydrobromide is 1.2-4.0mg/ (kg·d) according to the condition, and the micropump will be used at constant speed. After circulation stabilization and withdrawal of vasoactive drugs, the dosage will be reduced and gradually discontinued.

    The dosage of heparin is determined by the condition, 3000-6000U subcutaneous injection once a day; After circulation stabilization and withdrawal of vasoactive drugs, the dosage will be reduced and gradually discontinued.

    The dosage of anisodamine hydrobromide is 1.2-4.0mg/(kg·d) according to the condition, and the micropump will be used at constant speed. The dosage of heparin, depending on the condition, is 3000-6000U subcutaneous injection once a day; After circulation stabilization and withdrawal of vasoactive drugs, the dosage will be reduced and gradually discontinued.

    Conventional treatment includes antishock therapy, elimination of the cause, active treatment of the primary disease, replenishing blood volume, correcting acid-base imbalance, blood pressure maintenance with vasoactive drugs, and advanced life support, including advanced organ support such as ventilators and bedside hemofiltration, when the condition requires it.

    Outcomes

    Primary Outcome Measures

    Hospital mortality
    The patients will be followed up for 28 days, as our usual hospital length of stay for septic shock patients is 28 days. The investigators will recorded the specific time of death.

    Secondary Outcome Measures

    Lactate clearance rate

    Full Information

    First Posted
    November 9, 2022
    Last Updated
    November 29, 2022
    Sponsor
    Chen Ying
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05634057
    Brief Title
    Effectiveness of Anisodamine Hydrobromide Combined With Heparin for the Treatment of Critically Ill Patients With Septic Shock
    Official Title
    Effectiveness of Anisodamine Hydrobromide Combined With Heparin for the Treatment of Critically Ill Patients With Septic Shock: a Multicentre Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2022 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    May 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Chen Ying

    4. Oversight

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

    5. Study Description

    Brief Summary
    The study aimed to investigate the effectiveness of anisodamine hydrobromide combined with heparin in the treatment of septic shock, in the hope that the therapy will provide alternatives to the treatment of septic shock.
    Detailed Description
    Objective: The study aimed to investigate the effectiveness of anisodamine hydrobromide combined with heparin in the treatment of septic shock, in the hope that the therapy will provide alternatives to the treatment of septic shock. Methods: The study is a multi-center randomized controlled clinical trial. Study population will include critically ill patients with septic shock requiring vasopressor use. The critically ill patients with septic shock will be randomly assigned to four groups in a ratio of 1:1:1:1. The groups will consist of the conventional treatment group, the anisodamine hydrobromide treatment group, the heparin treatment group, and the anisodamine hydrobromide combined with heparin treatment group. Interim analysis will be performed. The primary study end point is 28-day mortality, and other secondary study endpoints include lactate clearance rate at 6h, 24h, and 72h, ICU mortality, length of stay in ICU and hospital, organ failure free days. The investigators will appropriately use chi-square test, student t test or rank sum test to compare the differences between the experimental group and the control group. Discussion: The treatment of anisodamine hydrobromide combined with heparin will be better than the conventional treatment. The study will provide new insight into the treatment of septic shock and can help to reduce mortality rate of septic shock.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Septic Shock

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The critically ill patients with septic shock will be randomly assigned to four groups in a ratio of 1:1:1:1. The groups will consist of the conventional treatment group, the anisodamine hydrobromide treatment group, the heparin treatment group, and the anisodamine hydrobromide combined with heparin treatment group.
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    384 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    anisodamine hydrobromide
    Arm Type
    Experimental
    Arm Description
    The dosage of anisodamine hydrobromide is 1.2-4.0mg/ (kg·d) according to the condition, and the micropump will be used at constant speed. After circulation stabilization and withdrawal of vasoactive drugs, the dosage will be reduced and gradually discontinued.
    Arm Title
    heparin
    Arm Type
    Experimental
    Arm Description
    The dosage of heparin is determined by the condition, 3000-6000U subcutaneous injection once a day; After circulation stabilization and withdrawal of vasoactive drugs, the dosage will be reduced and gradually discontinued.
    Arm Title
    Anisodamine hydrobromide combined with heparin
    Arm Type
    Experimental
    Arm Description
    The dosage of anisodamine hydrobromide is 1.2-4.0mg/(kg·d) according to the condition, and the micropump will be used at constant speed. The dosage of heparin, depending on the condition, is 3000-6000U subcutaneous injection once a day; After circulation stabilization and withdrawal of vasoactive drugs, the dosage will be reduced and gradually discontinued.
    Arm Title
    conventional therapy
    Arm Type
    No Intervention
    Arm Description
    Conventional treatment includes antishock therapy, elimination of the cause, active treatment of the primary disease, replenishing blood volume, correcting acid-base imbalance, blood pressure maintenance with vasoactive drugs, and advanced life support, including advanced organ support such as ventilators and bedside hemofiltration, when the condition requires it.
    Intervention Type
    Drug
    Intervention Name(s)
    Anisodamine hydrobromide
    Other Intervention Name(s)
    6-Hydroxyhyoscyamine hydrobromide, 55449-49-5
    Intervention Description
    The anisodamine hydrobromide treatment group is on the basis of conventional treatment.
    Intervention Type
    Drug
    Intervention Name(s)
    Heparin
    Intervention Description
    The heparin treatment group is on the basis of conventional treatment.
    Intervention Type
    Drug
    Intervention Name(s)
    Anisodamine hydrobromide combined with heparin
    Intervention Description
    The anisodamine hydrobromide combined with heparin treatment group is on the basis of conventional treatment.
    Primary Outcome Measure Information:
    Title
    Hospital mortality
    Description
    The patients will be followed up for 28 days, as our usual hospital length of stay for septic shock patients is 28 days. The investigators will recorded the specific time of death.
    Time Frame
    Every patients' survival time will be observed on day 28 after admission.
    Secondary Outcome Measure Information:
    Title
    Lactate clearance rate
    Time Frame
    The lactate clearance rate was observed at 6 hours, 24 hours, and 72 hours after admission.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with septic shock Exclusion Criteria: The age of <18 years or >80 years; Patients who were expected to die within 24h before enrollment; Patients who died or withdrew from the experiment due to serious diseases of heart, liver, kidney and other organs or mental diseases before reaching the end of the intervention effect; Patients had received treatment related to septic shock before enrollment, which may affect the observers of effect indicators; patients contraindicated with heparin and anisodamine; Refuse to sign the informed consent; Patients with thrombotic diseases requiring low molecular weight heparin treatment.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chen Ying
    Phone
    +8613538375709
    Email
    chenying_clytze@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effectiveness of Anisodamine Hydrobromide Combined With Heparin for the Treatment of Critically Ill Patients With Septic Shock

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