Back to resultsBalanced Salt Solution VS. Normal Saline Solution in Septic Shock
Primary Purpose
Shock, Septic, Sepsis
Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Ringer acetate
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Shock, Septic focused on measuring Severe sepsis, Balanced Salt Solution, Normal Saline
Eligibility Criteria
Inclusion Criteria:
- children younger than 18 year old who has severe sepsis or septic shock
- inform consent
Exclusion Criteria:
- children who had shock from other aetiologies
- end stage disease or severe congenital anomaly
- refuse to inform consent
Sites / Locations
- Department of Pediatric,Ramathibodi Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ringer Acetate
Normal saline
Arm Description
Ringer acetate 10-20 ml/kg IV bolus when patient need fluid bolus
NSS 10-20 ml/kg IV bolus when patient need fluid bolus
Outcomes
Primary Outcome Measures
incidence of hyperchloremic metabolic acidosis
Secondary Outcome Measures
28 day and 90 day mortality rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02336620
Brief Title
Balanced Salt Solution VS. Normal Saline Solution in Septic Shock
Official Title
Balanced Salt Solution Versus Normal Saline Solution During Initial Resuscitation in Severe Sepsis or Septic Shock Children: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
January 30, 2017 (Actual)
Study Completion Date
January 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ramathibodi Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The Purpose of this study is to determine the impact of balanced salt solution versus chloride rich solution on clinical outcomes in paediatric severe sepsis or septic shock
Detailed Description
The surviving sepsis campaign guideline recommended the isotonic crystalloids as the first choice of initial fluid resuscitation. The isotonic crystalloids are including chloride-rich solution (eg.NSS) and balanced salt solution. Retrospective study showed normal saline can induced hyperchloremic metabolic acidosis and acute kidney injury. However, no randomized controlled trial compare efficacy between the balanced salt solution and chloride rich solution.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shock, Septic, Sepsis
Keywords
Severe sepsis, Balanced Salt Solution, Normal Saline
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ringer Acetate
Arm Type
Experimental
Arm Description
Ringer acetate 10-20 ml/kg IV bolus when patient need fluid bolus
Arm Title
Normal saline
Arm Type
Active Comparator
Arm Description
NSS 10-20 ml/kg IV bolus when patient need fluid bolus
Intervention Type
Drug
Intervention Name(s)
Ringer acetate
Intervention Description
Ringer acetate 10-20 ml/kg IV bolus in 15-30 min,repeat bolus as needed by patient status
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
NSS
Intervention Description
NSS 10-20 ml/kg IV bolus in 15-30 min,repeat bolus as needed by patient status
Primary Outcome Measure Information:
Title
incidence of hyperchloremic metabolic acidosis
Time Frame
48 hour
Secondary Outcome Measure Information:
Title
28 day and 90 day mortality rate
Time Frame
28 days and 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children younger than 18 year old who has severe sepsis or septic shock
inform consent
Exclusion Criteria:
children who had shock from other aetiologies
end stage disease or severe congenital anomaly
refuse to inform consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nattachai Anantasit, M.D.
Organizational Affiliation
Ramathibodi Hospital, Bangkok
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatric,Ramathibodi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
12. IPD Sharing Statement
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Balanced Salt Solution VS. Normal Saline Solution in Septic Shock
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