Balanced fluid resuscitation to decrease kidney injury in children with septic shock with EFIC
Learn More About PRoMPT BOLUS!
Sponsor: National Institutes of Health via Children's Hospital of Philadelphia
Enrolling: Male and Female Patients
Study Length: 5 Years
IRB Number: AAAT4323
U.S. Govt. ID: NCT04102371
Contact: Dr. Maria Kwok: 212-305-4687 /
Additional Study Information: What's fast-moving, all-encompassing, and plays no favorites? Sepsis, an indiscriminate systemic condition that escalates so rapidly, national guidelines recommend treatment begin within 20 minutes of arrival to the emergency department. Crystalloid resuscitation with normal saline or balanced fluids (including lactated Ringers and Plasma-Lyte) is the current standard of care, but which is optimal is unknown. Researchers at Columbia University Irving Medical Center are considering doing a research study called the PROMPT BOLUS Trial (PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis). This research study is looking to find out which types of commonly used IV fluids (Normal Saline vs. Balanced Fluids) given in the emergency department is most effective to decrease organ injuries caused by sepsis. Sepsis is a severe inflammatory response to an infection that can cause low blood pressure and "shock." The PROMPT BOLUS Study would involve a special set of government rules that the U.S. Food and Drug Administration (FDA) has created. These rules are called "Exception from Informed Consent." They allow research studies to be done in an emergency without first asking for the person's consent. Because of this we are asking community members to think about this study now and let us know what you think about the study. Compensation will not be provided for participation in this study. We encourage you to contact us with any questions/concerns and/or complete an online survey, so that we may learn from each other. If parents/guardians prefer to not allow their child to be considered for this study in the event of sepsis, you can opt-out using the link below. 1. For general study-related inquiries/questions, 2. To complete an online survey, (English) (Spanish) 3. To opt-out,
Maria Kwok, MD, MPH
Do You Qualify?
Have you/your child been to the emergency department at Columbia University Medical Center/ New York Presbyterian Hospital? Yes No
Do you currently live in the Washington Heights/New York City area? Yes No
You may be eligible for this study

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For more information, please contact:
Dr. Maria Kwok