Balanced Salt Solution VS. Normal Saline Solution in Septic Shock

Ramathibodi Hospital60 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Shock, Septic Sepsis

Interventions

Ringer acetateDRUG

Ringer acetate 10-20 ml/kg IV bolus in 15-30 min,repeat bolus as needed by patient status

Normal salineDRUG

NSS 10-20 ml/kg IV bolus in 15-30 min,repeat bolus as needed by patient status

Eligibility

Sex: ALLMin age: 1 MonthMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Pediatric,Ramathibodi Hospital

Bangkok, Thailand

Outcomes

Primary Outcomes

incidence of hyperchloremic metabolic acidosis

Time frame: 48 hour

Secondary Outcomes

28 day and 90 day mortality rate

Time frame: 28 days and 90 days

Data from ClinicalTrials.gov

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