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Effect of Balanced Saline Solution and Albumin on Volume Expansion in Shock Patients

Primary Purpose

Shock

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Compound sodium acetate ringer injection
Albumin
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shock focused on measuring shock, sodium acetate ringer, albumin

Eligibility Criteria

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

Inclusion Criteria:

  1. Age ≥ 18 years old, gender unlimited

  2. Shock requires volume resuscitation:

    Insufficient tissue perfusion: wet and cold skin, decreased urine volume (<0.5ml/kg/h), change of consciousness, blood lactate >2.0mmol/l or vasoactive drugs are required to maintain map>65mmhg

  3. Presence of volume reactivity: (under controlled ventilation) PPV ≥ 15% or passive leg raising test (+) or (under controlled ventilation) IVC variability ≥ 18% or the presence of volume reactivity as judged by clinicians
  4. The patient has no obvious restlessness, RASS ≤ 0
  5. The legal representative of the subject signs the informed consent form-

Exclusion Criteria:

  1. Pregnant and lactating women
  2. End stage patients
  3. BMI ≤ 15 or BMI ≥ 50
  4. Contraindication of indwelling central vein catheter and invasive arterial catheter
  5. Patients in ECMO and / or IABP therapy
  6. Hemorrhagic shock, blood products such as concentrated red blood cells, plasma and platelets will be infused within 1 hour
  7. Myocardial infarction, NYHA grade IV
  8. Patients with hyperkalemia, hypercalcemia, hypermagnesemia and hypothyroidism
  9. Allergic to compound sodium acetate ringer injection or albumin or with known side effects
  10. Other factors that may affect the monitoring and evaluation of relevant indicators

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    sodium acetate ringer

    albumin

    Arm Description

    Outcomes

    Primary Outcome Measures

    Percentage of Cardiac output Index(CI) change
    The changes of cardiac output index before and after volume expansion were compared
    Percentage of Stroke Volume Index（SVI）change
    The changes of Stroke Volume Index before and after volume expansion were compared

    Secondary Outcome Measures

    Duration of Cardiac output Index(CI) change
    The duration of cardiac output index changes before and after volume expansion was compared
    Duration of Stroke Volume Index（SVI）change
    The duration of Stroke Volume Index changes before and after volume expansion was compared

    Full Information

    First Posted
    June 20, 2022
    Last Updated
    July 18, 2022
    Sponsor
    Peking Union Medical College Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05463471
    Brief Title
    Effect of Balanced Saline Solution and Albumin on Volume Expansion in Shock Patients
    Official Title
    Effect of Balanced Saline Solution and Albumin on Volume Expansion in Shock Patients: a Prospective Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2022 (Anticipated)
    Primary Completion Date
    December 12, 2025 (Anticipated)
    Study Completion Date
    December 12, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Peking Union Medical College Hospital

    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
    To compare the direct effect of sodium acetate ringer injection or albumin on volume expansion in shock patients, and to provide reference for volume resuscitation strategy in shock patients
    Detailed Description
    CI/SVI increase amplitude and maintenance time

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shock
    Keywords
    shock, sodium acetate ringer, albumin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    sodium acetate ringer
    Arm Type
    Experimental
    Arm Title
    albumin
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Compound sodium acetate ringer injection
    Intervention Description
    Quickly infuse 500ml of compound sodium acetate ringer injection for volume expansion within 20-30 minutes
    Intervention Type
    Drug
    Intervention Name(s)
    Albumin
    Intervention Description
    Quickly infuse 500ml of albumin for volume expansion within 20-30 minutes
    Primary Outcome Measure Information:
    Title
    Percentage of Cardiac output Index(CI) change
    Description
    The changes of cardiac output index before and after volume expansion were compared
    Time Frame
    2 hour
    Title
    Percentage of Stroke Volume Index（SVI）change
    Description
    The changes of Stroke Volume Index before and after volume expansion were compared
    Time Frame
    2 hour
    Secondary Outcome Measure Information:
    Title
    Duration of Cardiac output Index(CI) change
    Description
    The duration of cardiac output index changes before and after volume expansion was compared
    Time Frame
    2 hour
    Title
    Duration of Stroke Volume Index（SVI）change
    Description
    The duration of Stroke Volume Index changes before and after volume expansion was compared
    Time Frame
    2 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18 years old, gender unlimited Shock requires volume resuscitation: Insufficient tissue perfusion: wet and cold skin, decreased urine volume (<0.5ml/kg/h), change of consciousness, blood lactate >2.0mmol/l or vasoactive drugs are required to maintain map>65mmhg Presence of volume reactivity: (under controlled ventilation) PPV ≥ 15% or passive leg raising test (+) or (under controlled ventilation) IVC variability ≥ 18% or the presence of volume reactivity as judged by clinicians The patient has no obvious restlessness, RASS ≤ 0 The legal representative of the subject signs the informed consent form- Exclusion Criteria: Pregnant and lactating women End stage patients BMI ≤ 15 or BMI ≥ 50 Contraindication of indwelling central vein catheter and invasive arterial catheter Patients in ECMO and / or IABP therapy Hemorrhagic shock, blood products such as concentrated red blood cells, plasma and platelets will be infused within 1 hour Myocardial infarction, NYHA grade IV Patients with hyperkalemia, hypercalcemia, hypermagnesemia and hypothyroidism Allergic to compound sodium acetate ringer injection or albumin or with known side effects Other factors that may affect the monitoring and evaluation of relevant indicators
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yun Long, doctor
    Phone
    86-010-69152300
    Email
    ly_icu@aliyun.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effect of Balanced Saline Solution and Albumin on Volume Expansion in Shock Patients

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