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Shenfu Injection for Postoperative Delirium (SFI for POD) (POD)

Primary Purpose

Postoperative Delirium

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Shen-Fu injection
normal saline
Sponsored by
Shandong University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Delirium

Eligibility Criteria

75 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • hip fracture surgery under epidural anesthesia

Exclusion Criteria:

  • Severe dementia, hearing/vision impairment, coma, etc., unable to communicate;
  • patients with end-stage diseases such as tumor;
  • 3 months after myocardial infarction, cerebral infarction;
  • severe heart, liver and renal dysfunction.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    SFI intervention group

    Control group

    Arm Description

    shenfu injection used during surgery, day one and two after surgery, 50ml,iv drop.

    same volume of normal saline used during surgery, day one and two after surgery, 50ml,iv drop.

    Outcomes

    Primary Outcome Measures

    incidence of postoperative delirium within 7 days
    postoperative delirium(POD), assessed with Confusion Assessment Method scale and Richmond Agitation-Sedation Scale together.

    Secondary Outcome Measures

    non-delirium complications
    postoperative complications except for delirium
    length of stay
    length of hospital stay
    pain assessment within 3 days
    postoperative pain estimated with Numerical Rating Scale
    all-caused mortality within 30 days
    short-term follow up
    survival in 1 year
    long-term follow up
    adverse events to shenfu injection
    adverse events caused form shenfu injection

    Full Information

    First Posted
    November 16, 2021
    Last Updated
    December 20, 2021
    Sponsor
    Shandong University of Traditional Chinese Medicine
    Collaborators
    Shandong Institute of Science and Technology Information
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05179252
    Brief Title
    Shenfu Injection for Postoperative Delirium (SFI for POD)
    Acronym
    POD
    Official Title
    POD and Postoperative Outcomes in Senile Patients After SFI for Hip Fracture Surgery: A Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2022 (Anticipated)
    Primary Completion Date
    May 1, 2022 (Anticipated)
    Study Completion Date
    December 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shandong University of Traditional Chinese Medicine
    Collaborators
    Shandong Institute of Science and Technology Information

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Surgery or trauma may cause serious problem to patients, especially for senile ones, like postoperative delirium or more postoperative complications. Here, we conduct a investigation of SFI for preventing the happening of POD or postoperative complications.
    Detailed Description
    SFI(Shenfu Injection), a historical medical herbal medicine of traditional Chinese, which may produced much benefit to clinical patients with furtigue after major surgery, because it was a comment sense to think of energy loss if they experience surgical damage. Here, we administrated intravenously SFI into senile patients, who receiving hip fracture surgery, to avoid bad results or serious postoperative outcomes, in case of enhancing recovery after surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Delirium

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    350 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SFI intervention group
    Arm Type
    Experimental
    Arm Description
    shenfu injection used during surgery, day one and two after surgery, 50ml,iv drop.
    Arm Title
    Control group
    Arm Type
    Sham Comparator
    Arm Description
    same volume of normal saline used during surgery, day one and two after surgery, 50ml,iv drop.
    Intervention Type
    Drug
    Intervention Name(s)
    Shen-Fu injection
    Other Intervention Name(s)
    sanjiu yaan
    Intervention Description
    Chinese patent medicine made by modern technology
    Intervention Type
    Drug
    Intervention Name(s)
    normal saline
    Other Intervention Name(s)
    physiological saline solution
    Intervention Description
    0.9% normal saline, used for sham control
    Primary Outcome Measure Information:
    Title
    incidence of postoperative delirium within 7 days
    Description
    postoperative delirium(POD), assessed with Confusion Assessment Method scale and Richmond Agitation-Sedation Scale together.
    Time Frame
    day 1-7 after surgery, more scores means higher incidence of POD
    Secondary Outcome Measure Information:
    Title
    non-delirium complications
    Description
    postoperative complications except for delirium
    Time Frame
    day 1-7 after surgery
    Title
    length of stay
    Description
    length of hospital stay
    Time Frame
    approximately day 1 in hospital to day 7
    Title
    pain assessment within 3 days
    Description
    postoperative pain estimated with Numerical Rating Scale
    Time Frame
    day 1-3 after surgery, higher scores mean more pain.
    Title
    all-caused mortality within 30 days
    Description
    short-term follow up
    Time Frame
    30 days after surgery
    Title
    survival in 1 year
    Description
    long-term follow up
    Time Frame
    1 year discharge from hospital
    Title
    adverse events to shenfu injection
    Description
    adverse events caused form shenfu injection
    Time Frame
    approximately day1-7 after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    75 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: hip fracture surgery under epidural anesthesia Exclusion Criteria: Severe dementia, hearing/vision impairment, coma, etc., unable to communicate; patients with end-stage diseases such as tumor; 3 months after myocardial infarction, cerebral infarction; severe heart, liver and renal dysfunction.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    zhang weiliang
    Phone
    13365316885
    Email
    hezhangweiliang@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    zhang xin
    Phone
    0531-68616733
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    zhang xin
    Organizational Affiliation
    Shandong University of Traditional Chinese Medicine
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Shenfu Injection for Postoperative Delirium (SFI for POD)

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