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Low-chlorine Vs High-chlorine Crystalloids in Septic Shock Adults

Primary Purpose

Septic Shock

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Sodium Bicarbonate Ringer's Injection
0.9% Sodium Chloride Injection
Sponsored by
Southeast University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring crystalloids, septic shock, MAKE30

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18 years old <age ≤ 85 years old;
  2. Diagnosis of septic shock within 24 hours (sepsis 3.0);
  3. Needing fluid resuscitation judged by clinicians;
  4. The patient or the patient's legally acceptable representative signs the informed consent (signs within 24h of enrollment)

Exclusion Criteria:

  1. Pregnant or lactating period;
  2. Renal replacement therapy has been received or expected to receive within 6 hours;
  3. Those who were previously enrolled in the study;
  4. Estimated death within 24 hours;
  5. Other situations that not suitable for enrollment judged by researchers.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Sodium Bicarbonate Ringer's Injection

    0.9% Sodium Chloride Injection

    Arm Description

    administration route and dosage：Intravenous infusion, 500~1000 ml/time. The dosage can be increased or decreased according to the age, weight and symptoms. rate: according to the the routine rate of fluid resuscitation of septic shock in the ICUs of Zhongda Hospital, School of Medicine, Southeast University.

    administration route and dosage：Intravenous infusion, 500~1000 ml/time. The dosage can be increased or decreased according to the age, weight and symptoms. rate: according to the the routine rate of fluid resuscitation of septic shock in the ICUs of Zhongda Hospital, School of Medicine, Southeast University.

    Outcomes

    Primary Outcome Measures

    the composite of death and new receipt of renal-replacement therapy MAKE30
    overall incidence of death, new renal-replacement therapy, and persistent renal dysfunction within 30 days

    Secondary Outcome Measures

    Full Information

    First Posted
    April 24, 2020
    Last Updated
    April 27, 2020
    Sponsor
    Southeast University, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04365010
    Brief Title
    Low-chlorine Vs High-chlorine Crystalloids in Septic Shock Adults
    Official Title
    Effects of Low-chlorine Vs High-chlorine Crystalloid Solutions in Septic Shock Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2020 (Anticipated)
    Primary Completion Date
    September 2021 (Anticipated)
    Study Completion Date
    December 2021 (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 an important treatment in septic shock patients, however whether crystalloid composition affects septic shock patients outcomes remains unclear. According to previous studies, low-chlorine crystalloids could significantly reduce the incidence of kidney injury and 30-day mortality compared with high-chlorine crystalloids in critically ill adults. Therefore, we hypothesized that the use of low-chlorine crystalloids would result in a lower incidence of major adverse kidney events within 30 days (MAKE 30: overall incidence of death, new renal-replacement therapy, and persistent renal dysfunction) than high-chlorine crystalloids in septic shock adults.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Septic Shock
    Keywords
    crystalloids, septic shock, MAKE30

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Model Description
    Prospective cluster-randomized, multiple-crossover trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sodium Bicarbonate Ringer's Injection
    Arm Type
    Experimental
    Arm Description
    administration route and dosage：Intravenous infusion, 500~1000 ml/time. The dosage can be increased or decreased according to the age, weight and symptoms. rate: according to the the routine rate of fluid resuscitation of septic shock in the ICUs of Zhongda Hospital, School of Medicine, Southeast University.
    Arm Title
    0.9% Sodium Chloride Injection
    Arm Type
    Active Comparator
    Arm Description
    administration route and dosage：Intravenous infusion, 500~1000 ml/time. The dosage can be increased or decreased according to the age, weight and symptoms. rate: according to the the routine rate of fluid resuscitation of septic shock in the ICUs of Zhongda Hospital, School of Medicine, Southeast University.
    Intervention Type
    Drug
    Intervention Name(s)
    Sodium Bicarbonate Ringer's Injection
    Intervention Description
    For each month of the trial, participating ICUs were assigned to use either Sodium Bicarbonate Ringer's Injection or 0.9% Saline for any intravenous administration of isotonic crystalloid. ICUs were randomly assigned to use Sodium Bicarbonate Ringer's Injection during even-numbered months and 0.9% Saline during odd-numbered months, or vice versa.
    Intervention Type
    Drug
    Intervention Name(s)
    0.9% Sodium Chloride Injection
    Intervention Description
    For each month of the trial, participating ICUs were assigned to use either Sodium Bicarbonate Ringer's Injection or 0.9% Saline for any intravenous administration of isotonic crystalloid. ICUs were randomly assigned to use Sodium Bicarbonate Ringer's Injection during even-numbered months and 0.9% Saline during odd-numbered months, or vice versa.
    Primary Outcome Measure Information:
    Title
    the composite of death and new receipt of renal-replacement therapy MAKE30
    Description
    overall incidence of death, new renal-replacement therapy, and persistent renal dysfunction within 30 days
    Time Frame
    up to 30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years old <age ≤ 85 years old; Diagnosis of septic shock within 24 hours (sepsis 3.0); Needing fluid resuscitation judged by clinicians; The patient or the patient's legally acceptable representative signs the informed consent (signs within 24h of enrollment) Exclusion Criteria: Pregnant or lactating period; Renal replacement therapy has been received or expected to receive within 6 hours; Those who were previously enrolled in the study; Estimated death within 24 hours; Other situations that not suitable for enrollment judged by researchers.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Haibo Qiu, MD, PhD
    Phone
    0086-13951965301
    Email
    haiboq2000@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jianfeng Xie, MD, PhD
    Phone
    0086-13770332331
    Email
    xie820405@126.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Low-chlorine Vs High-chlorine Crystalloids in Septic Shock Adults

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