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Crystalloids for AKI in Shock Patients

Primary Purpose

Shock

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fluid resuscitation
Sponsored by
Southeast University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Shock focused on measuring shock, crystalloid, acute kidney injury

Eligibility Criteria

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

Inclusion Criteria:

  • Shock patients

Exclusion Criteria:

  • History of chronic renal failure

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Normal saline group

    Balanced solution group

    Arm Description

    Shock patients who resuscitated with normal saline were enrolled between June, 2015-June.2016.

    Shock patients who resuscitated with balanced solution were enrolled after June, 2016.

    Outcomes

    Primary Outcome Measures

    Incidence of acute kidney injury
    Diagnosis of acute kidney injury

    Secondary Outcome Measures

    Usage of renal replacement of therapy
    Usage of CRRT

    Full Information

    First Posted
    March 8, 2017
    Last Updated
    June 14, 2017
    Sponsor
    Southeast University, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03188614
    Brief Title
    Crystalloids for AKI in Shock Patients
    Official Title
    Different Crystalloids on the Incidence of Acute Kidney Injury in Shock Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2017 (Anticipated)
    Primary Completion Date
    September 1, 2018 (Anticipated)
    Study Completion Date
    October 1, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Southeast University, China

    4. Oversight

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

    5. Study Description

    Brief Summary
    Fluid resuscitation is important in shock therapy, but the choice of fluids, especially the choice of crystalloid is under debate. It is said that normal saline is related to hyperchloremia， which might lead to acute kidney injury. Thus the hypothesis of the study is to explicit whether balanced salt solution could reduce the incidence of acute kidney injury when compared with normal saline.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shock
    Keywords
    shock, crystalloid, acute kidney injury

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Normal saline group
    Arm Type
    Placebo Comparator
    Arm Description
    Shock patients who resuscitated with normal saline were enrolled between June, 2015-June.2016.
    Arm Title
    Balanced solution group
    Arm Type
    Experimental
    Arm Description
    Shock patients who resuscitated with balanced solution were enrolled after June, 2016.
    Intervention Type
    Drug
    Intervention Name(s)
    Fluid resuscitation
    Intervention Description
    The placebo group is resuscitated with normal saline, the experimental group is resuscitated with balanced fluid.
    Primary Outcome Measure Information:
    Title
    Incidence of acute kidney injury
    Description
    Diagnosis of acute kidney injury
    Time Frame
    28-day
    Secondary Outcome Measure Information:
    Title
    Usage of renal replacement of therapy
    Description
    Usage of CRRT
    Time Frame
    28-day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Shock patients Exclusion Criteria: History of chronic renal failure
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jingyuan Xu, Docotor
    Phone
    13851417209
    Email
    xujingyuanmail@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Haibo Qiu, Doctor
    Organizational Affiliation
    Southeast University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Crystalloids for AKI in Shock Patients

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