Balanced Salt Solution VS. Normal Saline Solution in Septic Shock
- Registration Number
- NCT02336620
- Lead Sponsor
- Ramathibodi Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ringer Acetate Ringer acetate Ringer acetate 10-20 ml/kg IV bolus when patient need fluid bolus Normal saline Normal saline NSS 10-20 ml/kg IV bolus when patient need fluid bolus
- Primary Outcome Measures
Name Time Method incidence of hyperchloremic metabolic acidosis 48 hour
- Secondary Outcome Measures
Name Time Method 28 day and 90 day mortality rate 28 days and 90 days
Trial Locations
- Locations (1)
Department of Pediatric,Ramathibodi Hospital
🇹ðŸ‡Bangkok, Thailand