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
Trial Overview
The study aims to test how well certain biomarkers called circulating micro RNAs (miRNAs) can detect and monitor pediatric sepsis compared to current biomarkers, by measuring changes in these miRNA levels in response to treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Healthy non-immunocompromised patients between 1-18 years old
Previously healthy, non-immunocompromised patients, between the ages of 1 and 18, who are being admitted to the PCH PICU for sepsis or septic shock, will be enrolled. Blood samples, urine samples and buccal swabs will be obtained from these patients at 5 time points to analyze biomarkers. Study participants will receive standard of care with antimicrobials and any additional appropriate cardiovascular or respiratory support per the clinical team. The samples will collected and stored at -80 until analysis can be performed. In addition to, during the course of the hospitalization, the enrolled patient will have data collected to calculate severity scores, including PRISM scores and TISS-28 scores. All patient information will be de-identified. A standard procedure manual will be developed detailing the methods for data collection and entry.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Phoenix Children's Hospital
Lead Sponsor
Citations
MicroRNA as Sepsis Biomarkers: A Comprehensive Review
MiRNAs hold great promise as diagnostic and prognostic biomarkers for sepsis, offering insights into the underlying molecular mechanisms and potential ...
miRNA sequencing identifies immune-associated ...
The results indicated that miR-193b-5p expression level was significantly reduced in septic patients and septic shock patients compared with ...
Significances of miRNAs for predicting sepsis mortality
This meta-analysis aims to comprehensively evaluate the diagnostic and prognostic value of miRNAs in predicting sepsis-related mortality.
Study on the diagnostic role of exosome-derived miRNAs in ...
This study aims to identify extracellular vesicle-derived miRNA signatures that differentiate septic shock from non-septic shock in postsurgical patients.
MicroRNAs in Sepsis - PMC
A literature overview was attempted to distinguish the most prominent miRs identified in septic conditions and their usefulness in diagnosis, prognosis and ...
Modes of action and diagnostic value of miRNAs in sepsis
During the hyper-inflammatory phase of early sepsis, anti-inflammatory miRNAs can provide benefit to the host by dampening excessive immune reactions. In the ...
MicroRNA as Sepsis Biomarkers: A Comprehensive Review
The observed fluctuations in miRNA levels during the course of sepsis offer valuable insights into the temporal dynamics of the disease process.
Role of miRNA dysregulation in sepsis - Molecular Medicine
MiRNAs are small RNA molecules that target mRNAs to inhibit or degrade their translation and have important roles in several disease processes including sepsis.
Exploring the Causal Relationship Between Circulating ...
MicroRNAs (miRNAs) play a crucial role in the pathophysiology of sepsis, with aberrant expression documented in peripheral blood samples ...
Role of extracellular and intracellular microRNAs in sepsis
Recently, one study profiled serum miRNAs of 214 sepsis patients (117 survivors and 97 non-survivors), and found that miR-223 levels were significantly lower in ...
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