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RCT Study of Levosimendan Improving Prognosis of Cardiac Arrest

Primary Purpose

Heart Arrest

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Levosimendan Injection
physiological saline
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Arrest focused on measuring cardiac arrest, Levosimendan Injection, prognosis

Eligibility Criteria

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

Inclusion Criteria: 1: Age>18 years old 2: After active Cardiopulmonary resuscitation, patients with cardiac arrest obtain the recovery of spontaneous circulation (ROSC), which is defined as having palpable arterial pulse lasting for more than 20 minutes 3: Patients with witnessed cardiac arrest 4: ROSC lasts for less than 60 minutes 5: Low cardiac output syndrome after ROSC (LVEF<40%) 6: Still in a coma after ROSC, Glasgow score<8 points 7: Complete enrollment within 180 minutes after ROSC Exclusion Criteria: 1: Patients receiving extracorporeal Cardiopulmonary resuscitation 2: Patients with severe neurological deficits prior to cardiac arrest 3: Patients with severe renal dysfunction (creatinine clearance rate<30ml/min) 4: Patients with confirmed or suspected pregnancy 5: Patients with Intracranial hemorrhage 6: Patients with end-stage diseases, such as advanced malignant tumors or other severe wasting diseases 7: Patients who are unwilling to participate in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Levosimendan group

    Placebo group

    Arm Description

    The administration scheme of Levosimendan is continuous intravenous infusion at the rate of 0.05-0.2 μg/kg/min for 24 hours, and no load is given to reduce the risk of Hypotension.

    The placebo group received continuous intravenous infusion of physiological saline at the rate of 0.05-0.2 μg/kg/min for 24 hours, while also receiving comprehensive cluster therapy with PCAS.

    Outcomes

    Primary Outcome Measures

    Cerebral Performance Category (CPC)
    The mortality rate and neurological prognosis at 30 days after cardiac arrest. The evaluation of neurological function adopts CPC score, with CPC 1-2 grading indicating a good prognosis for neurological function and CPC 3-5 grading indicating a poor prognosis for neurological function.

    Secondary Outcome Measures

    Survival rate
    Survival rate after 1 week of resuscitation was counted
    Echocardiography
    After enrollment, echocardiography parameters were collected according to the time nodes specified in this research process
    Neuron-Specific Enolase (NSE)
    After enrollment, NSE was collected according to the specified time points in this study process
    Gray-to-White Matter Ratio (GWR)
    After enrollment, head CT GWR were collected according to the specified time points in this study process
    Serum creatinine
    After enrollment, serum creatinine indicators representing renal function were collected according to the specified time

    Full Information

    First Posted
    July 4, 2023
    Last Updated
    July 13, 2023
    Sponsor
    Peking University Third Hospital
    Collaborators
    Qilu Hospital of Shandong University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05956431
    Brief Title
    RCT Study of Levosimendan Improving Prognosis of Cardiac Arrest
    Official Title
    A Randomized Controlled Clinical Study of Early Application of Levosimendan to Improve Cardiac Dysfunction and Neurological Prognosis in Patients With Cardiac Arrest
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University Third Hospital
    Collaborators
    Qilu Hospital of Shandong 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
    This study is intended to use a multicenter, double-blind, superior effect, placebo controlled randomized controlled clinical trial to explore the therapeutic effect of Levosimendan (within 6 hours after the recovery of spontaneous circulation) on mortality and multiple organ dysfunction such as heart and brain in patients with cardiac arrest who have recovered from active Cardiopulmonary resuscitation but have low cardiac output syndrome and coma, and the impact of 30-day mortality and neurological function after cardiac arrest.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Arrest
    Keywords
    cardiac arrest, Levosimendan Injection, prognosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Levosimendan group
    Arm Type
    Experimental
    Arm Description
    The administration scheme of Levosimendan is continuous intravenous infusion at the rate of 0.05-0.2 μg/kg/min for 24 hours, and no load is given to reduce the risk of Hypotension.
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    The placebo group received continuous intravenous infusion of physiological saline at the rate of 0.05-0.2 μg/kg/min for 24 hours, while also receiving comprehensive cluster therapy with PCAS.
    Intervention Type
    Drug
    Intervention Name(s)
    Levosimendan Injection
    Other Intervention Name(s)
    Intervention Group
    Intervention Description
    The administration scheme of Levosimendan is continuous intravenous infusion at the rate of 0.05-0.2 μg/kg/min for 24 hours, and no load is given to reduce the risk of Hypotension.
    Intervention Type
    Drug
    Intervention Name(s)
    physiological saline
    Other Intervention Name(s)
    Placebo Group
    Intervention Description
    The placebo group received continuous intravenous infusion of physiological saline at the rate of 0.05-0.2 μg/kg/min for 24 hours, while also receiving comprehensive cluster therapy with PCAS.
    Primary Outcome Measure Information:
    Title
    Cerebral Performance Category (CPC)
    Description
    The mortality rate and neurological prognosis at 30 days after cardiac arrest. The evaluation of neurological function adopts CPC score, with CPC 1-2 grading indicating a good prognosis for neurological function and CPC 3-5 grading indicating a poor prognosis for neurological function.
    Time Frame
    On the 30th day after cardiac arrest
    Secondary Outcome Measure Information:
    Title
    Survival rate
    Description
    Survival rate after 1 week of resuscitation was counted
    Time Frame
    after 1 week of resuscitation
    Title
    Echocardiography
    Description
    After enrollment, echocardiography parameters were collected according to the time nodes specified in this research process
    Time Frame
    On the first week after resuscitation
    Title
    Neuron-Specific Enolase (NSE)
    Description
    After enrollment, NSE was collected according to the specified time points in this study process
    Time Frame
    On the first week after resuscitation
    Title
    Gray-to-White Matter Ratio (GWR)
    Description
    After enrollment, head CT GWR were collected according to the specified time points in this study process
    Time Frame
    On the first week after resuscitation
    Title
    Serum creatinine
    Description
    After enrollment, serum creatinine indicators representing renal function were collected according to the specified time
    Time Frame
    On the first week after resuscitation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1: Age>18 years old 2: After active Cardiopulmonary resuscitation, patients with cardiac arrest obtain the recovery of spontaneous circulation (ROSC), which is defined as having palpable arterial pulse lasting for more than 20 minutes 3: Patients with witnessed cardiac arrest 4: ROSC lasts for less than 60 minutes 5: Low cardiac output syndrome after ROSC (LVEF<40%) 6: Still in a coma after ROSC, Glasgow score<8 points 7: Complete enrollment within 180 minutes after ROSC Exclusion Criteria: 1: Patients receiving extracorporeal Cardiopulmonary resuscitation 2: Patients with severe neurological deficits prior to cardiac arrest 3: Patients with severe renal dysfunction (creatinine clearance rate<30ml/min) 4: Patients with confirmed or suspected pregnancy 5: Patients with Intracranial hemorrhage 6: Patients with end-stage diseases, such as advanced malignant tumors or other severe wasting diseases 7: Patients who are unwilling to participate in the study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Du Lanfang, doctor
    Phone
    13810363269
    Email
    angelslovedudu@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ma Qingbian, doctor
    Organizational Affiliation
    Peking University Third Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The research results will be shared.
    IPD Sharing Time Frame
    When the study is fully completed, it can be shared.
    IPD Sharing Access Criteria
    open access

    Learn more about this trial

    RCT Study of Levosimendan Improving Prognosis of Cardiac Arrest

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