Balanced Salt Solution VS. Normal Saline Solution in Sept... | NCT02336620

Studies
Balanced Salt Solution VS. Normal Saline Solution in Septic Shock

NCT02336620

Sponsor

Ramathibodi Hospital

Status

Completed

Last Update Posted

Apr 26, 2017Actual

Enrollment

60Actual

Phase

Phase 3

Conditions

Shock, Septic
Sepsis

Interventions

Ringer acetate
Normal saline

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Jan 30, 2017Actual

Completion Date

Jan 30, 2017Actual

First Submitted Date

Jan 8, 2015

First Submission Date that Met QC Criteria

Jan 8, 2015

First Posted Date

Jan 13, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2017

Last Update Posted Date

Apr 26, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nattachai Anantasit, Pediatric Department, Ramathibodi Hospital, Ramathibodi HospitalPrincipal Investigator

Lead Sponsor

Ramathibodi HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ringer acetate	Drug	Ringer acetate 10-20 ml/kg IV bolus in 15-30 min,repeat bolus as needed by patient status	Ringer Acetate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of hyperchloremic metabolic acidosis		48 hour

Secondary Outcomes

Measure	Description	Time Frame
28 day and 90 day mortality rate		28 days and 90 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nattachai Anantasit, M.D.	Ramathibodi Hospital, Bangkok	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Pediatric,Ramathibodi Hospital		Bangkok		10400	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D012772	Shock, Septic
D018805	Sepsis

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077330	Saline Solution

Ancestor Terms

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided