Shock, Septic, Sepsis
Conditions
Keywords
Severe sepsis, Balanced Salt Solution, Normal Saline
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.
Interventions
DRUGRinger acetate
Ringer acetate 10-20 ml/kg IV bolus in 15-30 min,repeat bolus as needed by patient status
DRUGNormal saline
NSS 10-20 ml/kg IV bolus in 15-30 min,repeat bolus as needed by patient status
Sponsors
Ramathibodi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of hyperchloremic metabolic acidosis | 48 hour |
Secondary
| Measure | Time frame |
|---|---|
| 28 day and 90 day mortality rate | 28 days and 90 days |
Countries
Thailand
Outcome results
None listed