Image

Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis

Comparing saline solutions for sepsis treatment in children.

Recruiting
2-17 years
All
Phase 3

Septic shock is a severe condition caused by infection leading to dangerously low blood pressure. This study compares two fluids used in treatment: "normal" saline (NS) and balanced fluids (BF) like Lactated Ringer's and PlasmaLyte. It aims to see if BF is more effective and safer for children with septic shock, especially in preventing kidney injury (damage to the kidneys). About 5,000 children die from septic shock yearly in the US. All children in the study will receive initial care in the emergency department. The study will take place across 30+ locations and will include children aged 2 months to under 18 years. The study will assess major kidney issues and other health markers within 30 days.

  • Participation involves giving at least one fluid bolus and possibly more if needed.
  • The study requires parental consent but may proceed under specific emergency conditions.
  • Participants should not have certain health concerns, like severe liver or kidney problems.
Study details
    Shock
    Septic

NCT04102371

Children's Hospital of Philadelphia

10 October 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

  Other languages supported:

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.