Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-27 @ 8:09 PM
Study NCT ID:
NCT02336620
Status:
COMPLETED
Last Update Posted:
2017-04-26
First Post:
2015-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Balanced Salt Solution VS. Normal Saline Solution in Septic Shock
Sponsor:
Ramathibodi Hospital
Organization:
Study Overview
Official Title:
Balanced Salt Solution Versus Normal Saline Solution During Initial Resuscitation in Severe Sepsis or Septic Shock Children: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: