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High Strong Ion Difference Fluid vs Hartmann's Solution on Acid-Base Status in Sepsis (HiSIDSS)

Primary Purpose

Septicemic Shock

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High SID fluid
Hartmann's solution
Sponsored by
Clinical Research Centre, Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septicemic Shock

Eligibility Criteria

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

Inclusion Criteria:

  • age≥18 years
  • fulfills 2/3 qSOFA criteria
  • presumed infection
  • a blood pH at presentation ≤ 7.35
  • hyperlactatemia (blood lactate level, >2mmol/L )

Exclusion Criteria:

  • existing cardiac failure, major cardiac arrhythmia, advanced chronic kidney disease or end stage failure
  • known pregnancy
  • suspected dengue
  • primary diagnosis is related to burn, trauma, or drug overdose
  • if more than 500cc of resuscitation fluid was administered before enrollment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    High SID fluid

    Hartmann's solution

    Arm Description

    Group 1: half-normal saline with addition of 75mEq/L sodium bicarbonate

    Group 2: Hartmann's Solution

    Outcomes

    Primary Outcome Measures

    pH change
    bicarbonate level change
    mmol/L

    Secondary Outcome Measures

    Lactate level difference
    percentage
    Development of pulmonary edema
    30 days all-cause mortality
    Length of stay

    Full Information

    First Posted
    May 8, 2018
    Last Updated
    May 27, 2018
    Sponsor
    Clinical Research Centre, Malaysia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03530046
    Brief Title
    High Strong Ion Difference Fluid vs Hartmann's Solution on Acid-Base Status in Sepsis
    Acronym
    HiSIDSS
    Official Title
    A Double-Blind, Randomized Control Trial of Rapidly Infused High Strong Ion Difference Fluid Versus Hartmann's Solution on Acid-Base Status in Sepsis and Septic Shock Patients in the Emergency Department Hospital Pulau Pinang
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    December 18, 2017 (Actual)
    Study Completion Date
    January 18, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Clinical Research Centre, Malaysia

    4. Oversight

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

    5. Study Description

    Brief Summary
    This is a research to study primarily the effect of rapidly infused high strong ion difference (SID) fluid vs Hartmann's solution in altering the pH and bicarbonate level of the patient, who is in sepsis with metabolic acidosis. Half of the study population gets high SID fluid, while the other half will get Hartmann's solution.
    Detailed Description
    Balanced fluids are preferred in initial resuscitation of septic patients based on several recent studies. The Stewart's concept on acid-base balance predicts that high strong ion difference (SID) fluid thus will increase the pH level. High SID fluid are specially formulated by adding sodium bicarbonate into half saline solution, the resultant fluid contains sodium= 145mmol/L and chloride=70mmol/L (SID= 75) as compared to Hartmann's solution with the SID of 20.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Septicemic Shock

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    162 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    High SID fluid
    Arm Type
    Experimental
    Arm Description
    Group 1: half-normal saline with addition of 75mEq/L sodium bicarbonate
    Arm Title
    Hartmann's solution
    Arm Type
    Active Comparator
    Arm Description
    Group 2: Hartmann's Solution
    Intervention Type
    Combination Product
    Intervention Name(s)
    High SID fluid
    Intervention Description
    The fluid will be given to the patient at a rate prescribed by the treating physician according to clinical response for a period of 2 hours or up to maximum 30ml/kg fluid is given, whichever is earlier.
    Intervention Type
    Combination Product
    Intervention Name(s)
    Hartmann's solution
    Intervention Description
    The fluid will be given to the patient at a rate prescribed by the treating physician according to clinical response for a period of 2 hours or up to maximum 30ml/kg fluid is given, whichever is earlier.
    Primary Outcome Measure Information:
    Title
    pH change
    Time Frame
    2 hours
    Title
    bicarbonate level change
    Description
    mmol/L
    Time Frame
    2 hours
    Secondary Outcome Measure Information:
    Title
    Lactate level difference
    Description
    percentage
    Time Frame
    2 hours
    Title
    Development of pulmonary edema
    Time Frame
    48 hours
    Title
    30 days all-cause mortality
    Time Frame
    30 days
    Title
    Length of stay
    Time Frame
    90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age≥18 years fulfills 2/3 qSOFA criteria presumed infection a blood pH at presentation ≤ 7.35 hyperlactatemia (blood lactate level, >2mmol/L ) Exclusion Criteria: existing cardiac failure, major cardiac arrhythmia, advanced chronic kidney disease or end stage failure known pregnancy suspected dengue primary diagnosis is related to burn, trauma, or drug overdose if more than 500cc of resuscitation fluid was administered before enrollment.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chunchiat Yeoh, MD
    Organizational Affiliation
    Emergency Department, Hospital Pulau Pinang
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    High Strong Ion Difference Fluid vs Hartmann's Solution on Acid-Base Status in Sepsis

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