Balanced Salt Solution VS. Normal Saline Solution in Septic Shock

Sepsis Clinical Trial

Official title:

Balanced Salt Solution Versus Normal Saline Solution During Initial Resuscitation in Severe Sepsis or Septic Shock Children: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02336620
• Other study ID #: RF_58015
• Status: Completed
• Phase: Phase 3
• First received: January 8, 2015
• Last updated: April 25, 2017
• Start date: December 2014
• Est. completion date: January 30, 2017

Study information

• Verified date: April 2017
• Source: Ramathibodi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 30, 2017
• Est. primary completion date: January 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Shock
• Shock, Septic

Intervention

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

Locations

Country	Name	City	State
Thailand	Department of Pediatric,Ramathibodi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Ramathibodi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of hyperchloremic metabolic acidosis		48 hour
Secondary	28 day and 90 day mortality rate		28 days and 90 days