NCT02336620

Balanced Salt Solution VS. Normal Saline Solution in Septic Shock

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ramathibodi Hospital · Academic / Other
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Shock, Septic
• Sepsis

Interventions

Type	Name	Description
DRUG	Ringer acetate	Ringer acetate 10-20 ml/kg IV bolus in 15-30 min,repeat bolus as needed by patient status
DRUG	Normal saline	NSS 10-20 ml/kg IV bolus in 15-30 min,repeat bolus as needed by patient status

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-01-30
• Completion: 2017-01-30
• First posted: 2015-01-13
• Last updated: 2017-04-26

Locations

1 site across 1 country: Thailand