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Completed

NCT Number: NCT02336620

Balanced Salt Solution VS. Normal Saline Solution in Septic Shock

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

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Key information

Conditions

Shock, Septic Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Systemic Inflammatory Response Syndrome

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Pediatric,Ramathibodi Hospital

Bangkok, 10400, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ringer acetate

Drug

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

normal saline

Drug

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

Other names: NSS

Primary outcomes

  1. incidence of hyperchloremic metabolic acidosis

    Time frame: 48 hour

Secondary outcomes

  1. 28 day and 90 day mortality rate

    Time frame: 28 days and 90 days

Sponsors and collaborators

Lead sponsor

Ramathibodi Hospital

Other

Registry information

Official study title

Balanced Salt Solution Versus Normal Saline Solution During Initial Resuscitation in Severe Sepsis or Septic Shock Children: A Randomized Controlled Trial

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 13, 2015
Registry last updated
Apr 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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