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

  • Thailand
      • Bangkok, Thailand, 10400
        • Department of Pediatric,Ramathibodi Hospital

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
Drug: Ringer acetate
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
Drug: Normal saline
NSS 10-20 ml/kg IV bolus in 15-30 min,repeat bolus as needed by patient status
Other Names:
  • NSS

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

Ramathibodi Hospital

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

Keywords

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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