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Adjunctive Esketamine for Analgesia in Mechanically Ventilated Septic Shock Patients

Primary Purpose

Septic Shock, Mechanical Ventilation Complication

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Esketamine
Saline
Remifentanil + propofol
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring Esketamine, Vasoactive drugs, sedation, analgesia

Eligibility Criteria

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

Inclusion Criteria: Age ≥ 18; A patient diagnosed with septic shock; It needs to be treated with analgesics, sedatives, and vasopressors for a period of not less than 48 hours; Mechanical ventilation by the ventilator is needed; Obtain the informed consent of the human subjects or their legal representatives; Exclusion Criteria: Pregnant patient The patient had acute coronary syndrome, NYHA grade IV, or refractory heart failure; Any other condition that may seriously interfere with the collection of research data, such as loss of hearing or vision; any allergic reaction to any of the research drugs; The clinician determines that a patient who is unlikely to be separated from mechanical ventilation, such as a disease/injury that primarily affects the neuromuscular function of the respirator and an apparently irreversible disease requiring long-term ventilation support (such as high spinal cord injury); The researcher judged that it was not suitable to participate in the study;

Sites / Locations

  • Southern medical university Nanfang hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Remifentanil + propofol + esketamine

remifentanil + propofol + saline

Arm Description

esketamine (2ml; 50mg), Remifentanil Hydrochloride for Injection (1mg;), propofol injection (50ml; 0.5g; ); The frequency of use is determined by responsible clinicians.All analgesic and sedative drugs used are adjusted according to the actual situation of the patient.

Remifentanil Hydrochloride for Injection (1mg;), propofol injection (50ml; 0.5g; ); The amount of saline used is equivalent to the amount of esketamine.All analgesic and sedative drugs used are adjusted according to the actual situation of the

Outcomes

Primary Outcome Measures

Doses of remifentanil and norepinephrine during mechanical ventilation (total dose/duration of use).
Responsible researchers consult the patient's medical record after completing treatment to obtain the dosage and duration of medication.

Secondary Outcome Measures

Duration of mechanical ventilation.
Responsible researchers obtain information by viewing electronic medical records.
No ventilator days.
Responsible researchers obtain information by viewing electronic medical records.
Propofol dosage (total dose/duration of use) during mechanical ventilation.
Responsible researchers consult the patient's medical record after completing treatment to obtain the dosage and duration of medication.
The proportion of patients meeting the RASS sedation and CPOT pain goals during mechanical ventilation.
Professionally trained researchers perform RASS and COPT scores on patients at specific time points.
The incidence of delirium, i.e. the positive rate of CAM-ICU.
The occurrence of delirium in patients will be recorded by clinicians or nurses on medical records, and researchers will summarize the occurrence of delirium (such as the time of occurrence, duration, treatment measures, etc.)Patients will be evaluated using CAM-ICU by clinicians or nurses.
Incidence of adverse events.
The occurrence of adverse events during the hospital period will be recorded in the medical record by the clinician or nurse, and the researcher will obtain the occurrence of adverse events (event type, time, treatment, results, etc.) through the medical record.
length of ICU stay.
Researchers obtain it through the hospital electronic system.
The mortality rate
Researchers obtain it through the hospital electronic system.

Full Information

First Posted
March 20, 2023
Last Updated
June 30, 2023
Sponsor
Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05839366
Brief Title
Adjunctive Esketamine for Analgesia in Mechanically Ventilated Septic Shock Patients
Official Title
Adjunctive Esketamine for Analgesia in Mechanically Ventilated ICU Septic Shock Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 31, 2021 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University

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
Sedation and analgesia in patients with sepsis and hemodynamic instability may be challenging in the ICU. Opioids and propofol can further exacerbate tissue infusion in septic shock by reducing cardiac contractility, increasing vasodilation, and reducing respiratory drive. Ketamine is an NMDA receptor antagonist, which has no effect on respiratory drive and has diastolic airway smooth muscle and anti-inflammatory properties. Esketamine is a dextrorotatory cleavage twice as potent and reduces the incidence of dose-dependent side effects of ketamine. Although it has been successfully used in burn patients undergoing multiple operations and anesthesia-related maintenance analgesia, it has not been reported in ICU septic shock patients undergoing mechanical ventilation. The purpose of this study was to explore the use of esketamine in mechanically ventilated ICU septic shock patients in a single-center randomized controlled trial.
Detailed Description
In order to further clarify whether Esketamine can be used as a conventional continuous intravenous infusion drug in the ICU, further RCT is required. Therefore, this project assumes that low-dose Esketamine has a clear analgesic and sedative effect, and has advantages such as less adverse reactions in hemodynamics, respiratory inhibition, and gastrointestinal peristalsis. It is proposed to complete the following work: on the standard analgesia and sedation scheme (remifentanil+propofol), evaluate the feasibility, effectiveness and safety of the auxiliary analgesia scheme added with esketamine for septic shock patients with mechanical ventilation by whether to load small dose of esketamine for infusion, so as to provide basis for follow-up individualized diagnosis and treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock, Mechanical Ventilation Complication
Keywords
Esketamine, Vasoactive drugs, sedation, analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remifentanil + propofol + esketamine
Arm Type
Active Comparator
Arm Description
esketamine (2ml; 50mg), Remifentanil Hydrochloride for Injection (1mg;), propofol injection (50ml; 0.5g; ); The frequency of use is determined by responsible clinicians.All analgesic and sedative drugs used are adjusted according to the actual situation of the patient.
Arm Title
remifentanil + propofol + saline
Arm Type
Placebo Comparator
Arm Description
Remifentanil Hydrochloride for Injection (1mg;), propofol injection (50ml; 0.5g; ); The amount of saline used is equivalent to the amount of esketamine.All analgesic and sedative drugs used are adjusted according to the actual situation of the
Intervention Type
Drug
Intervention Name(s)
Esketamine
Other Intervention Name(s)
Esketamine Hydrochloride Injection
Intervention Description
Load dose of 0.25 mg/kg, and the fixed infusion rate of 0.15 mg/kg/h.The load dose will be injected intravenously within 1-2 minutes. Preparation: 50ml of saline + 2ml of eskeamine.
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
physiological saline; saline solution
Intervention Description
As a placebo,normal saline at the same dose as esketamine.Saline is also administered intravenously.
Intervention Type
Drug
Intervention Name(s)
Remifentanil + propofol
Intervention Description
Remifentanil + propofol
Primary Outcome Measure Information:
Title
Doses of remifentanil and norepinephrine during mechanical ventilation (total dose/duration of use).
Description
Responsible researchers consult the patient's medical record after completing treatment to obtain the dosage and duration of medication.
Time Frame
During mechanical ventilation procedure (From randomization to the seventh day of infusion or ventilator withdrawal, whichever occurs first)
Secondary Outcome Measure Information:
Title
Duration of mechanical ventilation.
Description
Responsible researchers obtain information by viewing electronic medical records.
Time Frame
From endotracheal intubation to withdrawal from mechanical ventilation, or until 28 days after discharge, death, or randomization in the ICU, whichever occurs
Title
No ventilator days.
Description
Responsible researchers obtain information by viewing electronic medical records.
Time Frame
Days to 28
Title
Propofol dosage (total dose/duration of use) during mechanical ventilation.
Description
Responsible researchers consult the patient's medical record after completing treatment to obtain the dosage and duration of medication.
Time Frame
During mechanical ventilation procedure (From randomization to the seventh day of infusion or ventilator withdrawal, whichever occurs first)
Title
The proportion of patients meeting the RASS sedation and CPOT pain goals during mechanical ventilation.
Description
Professionally trained researchers perform RASS and COPT scores on patients at specific time points.
Time Frame
up to 28 days
Title
The incidence of delirium, i.e. the positive rate of CAM-ICU.
Description
The occurrence of delirium in patients will be recorded by clinicians or nurses on medical records, and researchers will summarize the occurrence of delirium (such as the time of occurrence, duration, treatment measures, etc.)Patients will be evaluated using CAM-ICU by clinicians or nurses.
Time Frame
up to 28 days
Title
Incidence of adverse events.
Description
The occurrence of adverse events during the hospital period will be recorded in the medical record by the clinician or nurse, and the researcher will obtain the occurrence of adverse events (event type, time, treatment, results, etc.) through the medical record.
Time Frame
up to 28 days
Title
length of ICU stay.
Description
Researchers obtain it through the hospital electronic system.
Time Frame
up to 28 days
Title
The mortality rate
Description
Researchers obtain it through the hospital electronic system.
Time Frame
up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18; A patient diagnosed with septic shock; It needs to be treated with analgesics, sedatives, and vasopressors for a period of not less than 48 hours; Mechanical ventilation by the ventilator is needed; Obtain the informed consent of the human subjects or their legal representatives; Exclusion Criteria: Pregnant patient The patient had acute coronary syndrome, NYHA grade IV, or refractory heart failure; Any other condition that may seriously interfere with the collection of research data, such as loss of hearing or vision; any allergic reaction to any of the research drugs; The clinician determines that a patient who is unlikely to be separated from mechanical ventilation, such as a disease/injury that primarily affects the neuromuscular function of the respirator and an apparently irreversible disease requiring long-term ventilation support (such as high spinal cord injury); The researcher judged that it was not suitable to participate in the study;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongbin Hu, doctor
Phone
+86139224837
Email
hobewoos@163.com
Facility Information:
Facility Name
Southern medical university Nanfang hospital
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongbin Hu, doctor
Phone
+8613922483752
Email
hobewoos@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Adjunctive Esketamine for Analgesia in Mechanically Ventilated Septic Shock Patients

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