NCT02336620

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2017

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

2.2 years

First QC Date

January 8, 2015

Last Update Submit

April 25, 2017

Conditions

Shock, SepticSepsis

Keywords

Severe sepsis, Balanced Salt Solution, Normal Saline

Outcome Measures

Primary Outcomes (1)

  • incidence of hyperchloremic metabolic acidosis

    48 hour

Secondary Outcomes (1)

  • 28 day and 90 day mortality rate

    28 days and 90 days

Study Arms (2)

Ringer Acetate

EXPERIMENTAL

Ringer acetate 10-20 ml/kg IV bolus when patient need fluid bolus

Drug: Ringer acetate

Normal saline

ACTIVE COMPARATOR

NSS 10-20 ml/kg IV bolus when patient need fluid bolus

Drug: Normal saline

Interventions

Ringer acetateDRUG

Ringer acetate 10-20 ml/kg IV bolus in 15-30 min,repeat bolus as needed by patient status

Ringer Acetate
Normal salineDRUG

NSS 10-20 ml/kg IV bolus in 15-30 min,repeat bolus as needed by patient status

Also known as: NSS
Normal saline

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • children younger than 18 year old who has severe sepsis or septic shock
  • inform consent

You may not qualify if:

  • children who had shock from other aetiologies
  • end stage disease or severe congenital anomaly
  • refuse to inform consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatric,Ramathibodi Hospital

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Shock, SepticSepsis

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Nattachai Anantasit, M.D.

    Ramathibodi Hospital, Bangkok

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Department, Ramathibodi Hospital

Study Record Dates

First Submitted

January 8, 2015

First Posted

January 13, 2015

Study Start

December 1, 2014

Primary Completion

January 30, 2017

Study Completion

January 30, 2017

Last Updated

April 26, 2017

Record last verified: 2017-04

Locations

TH(1)