miRNA for Pediatric Sepsis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to improve the detection and monitoring of sepsis in children by using special blood markers called micro RNA (miRNA) biomarkers. Researchers seek to determine if these markers are more effective at identifying and tracking sepsis than current methods. Children aged 1 to 18 with sepsis or septic shock admitted to the Pediatric Intensive Care Unit (PICU) may be suitable for this study. Participants will receive standard sepsis care, and their samples will be collected for analysis. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future sepsis care for children.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that detecting miRNA biomarkers is safe for pediatric patients?
Research shows that tiny molecules called microRNAs (miRNAs) play an important role in sepsis, a serious condition caused by the body's response to infection. These miRNAs help control inflammation, a key part of the body's defense system. Studies have found that changes in miRNA levels in sepsis patients provide important information about the disease.
Regarding safety, miRNAs are naturally present in the body and have been studied in many sepsis cases, suggesting they are generally safe. Studies focusing on their role in sepsis have not reported major harmful effects. However, while researchers study miRNAs for their potential benefits, their complete safety profile is still under investigation. Participants should consider this when deciding whether to join a trial.12345Why are researchers excited about this trial?
Researchers are excited about exploring miRNA in the context of pediatric sepsis because it offers a new way to understand and potentially treat this serious condition. Unlike traditional treatments that primarily rely on antibiotics and supportive care, miRNA targets the molecular mechanisms at play during sepsis. This could lead to more precise interventions by modulating the body's response at the genetic level. If successful, this approach might not only improve outcomes but also offer insights into personalized medicine for sepsis in children.
What evidence suggests that miRNA is effective for detecting sepsis?
Research shows that tiny molecules called microRNAs (miRNAs) could help identify and predict sepsis, a serious medical condition. Biomarkers, like miRNAs, are measurable signs that can indicate a disease. Studies have found that miRNAs can aid in diagnosing sepsis and predicting its progression. For instance, a specific miRNA known as miR-193b-5p appears at lower levels in people with sepsis and septic shock. Other research indicates that certain miRNA patterns can distinguish septic shock from other conditions. Overall, researchers are studying miRNAs for their potential to improve the diagnosis and understanding of sepsis. This trial will include both patients with sepsis or septic shock and healthy individuals, allowing for a comparison of miRNA patterns between these groups.678910
Who Is on the Research Team?
Frederick A Willyerd, MD
Principal Investigator
Phoenix Children's Hospital
Are You a Good Fit for This Trial?
This trial is for children in the Pediatric Intensive Care Unit (PICU) suspected of having sepsis or who develop sepsis within their hospital stay. They must join the study from when they arrive at the Emergency Department up to 24 hours after starting antibiotics for sepsis or shock, with signed informed consent.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment and Monitoring
Participants receive standard of care with antimicrobials and any additional appropriate cardiovascular or respiratory support. Biomarker samples are collected at 5 time points.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including the calculation of severity scores such as PRISM III and TISS-28.
What Are the Treatments Tested in This Trial?
Interventions
- miRNA in Sepsis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Phoenix Children's Hospital
Lead Sponsor