Balanced Salt Solution VS. Normal Saline Solution in Septic Shock

Mahidol University

Status and phase: Completed; Phase 3

Conditions: Shock, Septic; Sepsis

Treatments: Drug: Normal saline; Drug: Ringer acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT02336620

RF_58015

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Ringer Acetate

Experimental group

Description:

Ringer acetate 10-20 ml/kg IV bolus when patient need fluid bolus

Treatment:

Drug: Ringer acetate

Normal saline

Active Comparator group

Description:

NSS 10-20 ml/kg IV bolus when patient need fluid bolus

Treatment:

Drug: Normal saline