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Correlating MicroRNA Changes With Sepsis Outcomes

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ClinicalTrials.gov Identifier: NCT03929159
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This trial studies how changes in microRNAs may correlate with sepsis outcomes. Sepsis is a type of severe infection of the blood stream, and its diagnosis may be obscured by many other conditions such as surgery, trauma, and cancer. MicroRNAs are biomarkers found in the blood and tissue. Blood samples may help correlate changes in microRNA expression to patient reactions to a sepsis infection.

Condition or disease Intervention/treatment
Septicemia Procedure: Biospecimen Collection

Detailed Description:

PRIMARY OBJECTIVES:

I. To examine whether the cellular and viral micro ribonucleic acid (miRNA) changes in plasma and peripheral mononuclear blood cells (PMNCs) correlate with the diagnosis and outcome of sepsis.

SECONDARY OBJECTIVES:

I. To distinguish systemic inflammatory response syndrome (SIRS) without infection from sepsis and septic shock.

OUTLINE: Patients are assigned to 1 of 2 groups.

GROUP A: Patients undergo blood specimen collection at baseline (before surgery), the day after surgery, either the day of hospital discharge or the day of sepsis diagnosis, and 6 days after the baseline blood draw if still hospitalized.

GROUP B: Patients undergo blood specimen collection at baseline (day of sepsis diagnosis), the day after baseline, and on day 7 from baseline if still hospitalized.


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Study Type : Observational
Estimated Enrollment : 225 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Profile of miRNA Changes in Sepsis and Surgical Trauma
Actual Study Start Date : March 26, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort Intervention/treatment
Group A (biospecimen collection)
Patients undergo blood specimen collection at baseline (before surgery), the day after surgery, either the day of hospital discharge or the day of sepsis diagnosis, and 6 days after the baseline blood draw if still hospitalized.
Procedure: Biospecimen Collection
Undergo blood biospecimen collection

Group B (biospecimen collection)
Patients undergo blood specimen collection at baseline (day of sepsis diagnosis), the day after baseline, and on day 7 from baseline if still hospitalized.
Procedure: Biospecimen Collection
Undergo blood biospecimen collection




Primary Outcome Measures :
  1. Change in cellular and viral micro ribonucleic acids (miRNAs) [ Time Frame: Baseline up to day 1 ]
    For each of the cellular and viral miRNAs, samples from patients with sepsis versus (vs.) patients with systemic inflammatory response syndrome (SIRS) without sepsis vs. patients presenting for pre-op evaluation (reference group without SIRS or sepsis) will be compared by one-way analysis of variance. Will compare the miRNA expression intergroup differences.

  2. 7-day mortality rate [ Time Frame: Baseline up to day 7 ]
    Will be correlated with miRNA changes. Will compare the changes of the miRNAs from baseline to day 1 between the patients who were still alive 7 days after diagnosis of sepsis and those who died within 7 days of sepsis diagnosis.


Secondary Outcome Measures :
  1. T and B cells immune phenotypes [ Time Frame: Up to 2 years ]

Biospecimen Retention:   Samples With DNA
Blood, plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients electively scheduled for surgical operation requiring anesthesia and hospitalization of longer than 1 day, or patients with high clinical suspicion of sepsis
Criteria

Inclusion Criteria:

  • Electively scheduled for surgical operation that require general anesthesia and expected duration of hospitalization of longer than one day (for patients in Perioperative Evaluation & Management [POEM]) or high clinical suspicion of sepsis by the emergency physician (for patients in emergency center)
  • Ability to give informed consent. If the patient is incapacitated and unable to give informed consent, the next-of-kin or a person who has the power of attorney must be present for informed consent.
  • For patients in the emergency center only, two or more of the following SIRS criteria:

    • Leukocytes > 12,000/mm^3 or < 4,000/mm^3 or > 10% immature (band) forms, provided that no filgrastim or pegfilgrastim was administered within 30 days and no leukemia
    • Heart rate > 90 beats/minute (min)
    • Respiratory rate > 20 breaths/min or partial pressure of carbon dioxide (CO2) < 32 mmHg
    • Oral temperature > 38 degrees Celsius (C) or < 36 degrees C or axillary temperature > 37 degrees C or < 35 degrees C

Exclusion Criteria:

  • Inability to give informed consent or a person who has power of attorney for medical decision is not available
  • Being moribund (for patients in emergency center) or cancellation of surgery (for patients in POEM)
  • Active "Do Not Resuscitate" or "Do Not Intubate" order

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929159


Contacts
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Contact: Sai-Ching J. Yeung 713-745-9911 syeung@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Sai-Ching J. Yeung    713-745-9911      
Principal Investigator: Sai-Ching J. Yeung         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
National Institute of General Medical Sciences (NIGMS)
Investigators
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Principal Investigator: Sai-Ching J Yeung M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03929159     History of Changes
Other Study ID Numbers: 2018-0757
NCI-2019-00833 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0757 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
R01GM122775 ( U.S. NIH Grant/Contract )
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes