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NCT04102371RECRUITINGIRB Ready

Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis

(PRoMPT BOLUS)

Sponsored by Children's Hospital of Philadelphia

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
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1 of 8800 participants interested
0% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

The objectives of this multicenter pragmatic clinical trial are to compare the effectiveness and relative safety of balanced fluid resuscitation versus 0.9% "normal" saline in children with septic shock, including whether balanced fluid resuscitation can reduce progression of kidney injury.

Who Can Participate

Inclusion Criteria

Males or females age \>2 months to \<18 years 2. Clinician concern for septic shock, operationalized as: 1. a "positive" ED sepsis alert confirmed by a physician OR 2. physician decision to treat for septic shock OR 3. a physician diagnosis of septic shock requiring parenteral antibiotics and fluid resuscitation 3. Administration of at least one IV/Intraosseous (IO) fluid bolus for resuscitation and additional fluid deemed likely to be necessary to treat poor perfusion, or clinician judgment that \>1 fluid bolus is highly likely to be required. Poor perfusion is defined as physician's judgement of hypotension or abnormal (either "flash" or "prolonged") capillary refill. 4. Receipt of โ‰ค40 mL/kg IV/IO total crystalloid fluid prior to randomization 5. Parental/guardian permission (informed consent) if time permits; otherwise, Exception from informed consent (EFIC) criteria met

Exclusion Criteria

Treating physician judges that patient's condition dee

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

8800 participants

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Age Range

2 Months - 17 Years

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Gender

ALL

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Sponsor

Children's Hospital of Philadelphia

Study Locations

Choose your preferred location or select flexible during enrollment

Unknown

Davis

California

Location available
View Davis location page
Unknown

Los Angeles

California

Location available
View Los Angeles location page
Unknown

San Francisco

California

Location available
View San Francisco location page
Unknown

Denver

Colorado

Location available
View Denver location page
Unknown

Emory

Georgia

Location available
View Emory location page
Unknown

Chicago

Illinois

Location available
View Chicago location page
Unknown

Boston

Massachusetts

Location available
View Boston location page
Unknown

Ann Arbor

Michigan

Location available
View Ann Arbor location page
Unknown

St Louis

Missouri

Location available
View St Louis location page

๐Ÿ“ And 13 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Septic Shock Treatment in Davis?

Join others in California exploring innovative treatment options through clinical research

Septic Shock Treatment Options in Davis, California

If you're searching for Septic Shock treatment in Davis, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Davis, Los Angeles, San Francisco and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Septic Shock. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 8800 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Septic Shock?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Septic Shock

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Septic Shock Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT04102371. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.