- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02336620
Balanced Salt Solution VS. Normal Saline Solution in Septic Shock
April 25, 2017 updated by: Nattachai Anantasit, Ramathibodi Hospital
Balanced Salt Solution Versus Normal Saline Solution During Initial Resuscitation in Severe Sepsis or Septic Shock Children: A Randomized Controlled Trial
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bangkok, Thailand, 10400
- Department of Pediatric,Ramathibodi Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ringer Acetate
Ringer acetate 10-20 ml/kg IV bolus when patient need fluid bolus
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Ringer acetate 10-20 ml/kg IV bolus in 15-30 min,repeat bolus as needed by patient status
|
Active Comparator: Normal saline
NSS 10-20 ml/kg IV bolus when patient need fluid bolus
|
NSS 10-20 ml/kg IV bolus in 15-30 min,repeat bolus as needed by patient status
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
incidence of hyperchloremic metabolic acidosis
Time Frame: 48 hour
|
48 hour
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
28 day and 90 day mortality rate
Time Frame: 28 days and 90 days
|
28 days and 90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nattachai Anantasit, M.D., Ramathibodi Hospital, Bangkok
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Actual)
January 30, 2017
Study Completion (Actual)
January 30, 2017
Study Registration Dates
First Submitted
January 8, 2015
First Submitted That Met QC Criteria
January 8, 2015
First Posted (Estimate)
January 13, 2015
Study Record Updates
Last Update Posted (Actual)
April 26, 2017
Last Update Submitted That Met QC Criteria
April 25, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RF_58015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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