Balanced Salt Solution VS. Normal Saline Solution in Septic Shock

NCT ID: NCT02336620

Last Updated: 2017-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2017-01-30

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.

Conditions

Shock, Septic; Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ringer Acetate

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

Group Type: EXPERIMENTAL

Ringer acetate

Intervention Type: DRUG

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

Normal saline

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

Group Type: ACTIVE_COMPARATOR

Normal saline

Intervention Type: DRUG

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

Interventions

Ringer acetate

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

Intervention Type: DRUG

Normal saline

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

Intervention Type: DRUG

Other Intervention Names

NSS

Eligibility Criteria

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ramathibodi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nattachai Anantasit

Pediatric Department, Ramathibodi Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nattachai Anantasit, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ramathibodi Hospital, Bangkok

Locations

Department of Pediatric,Ramathibodi Hospital

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

RF_58015

Identifier Type: -

Identifier Source: org_study_id