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Quantification of Bacterial DNA in Sepsis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03782454
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : January 29, 2019
Information provided by (Responsible Party):
Region Örebro County

Brief Summary:
The purpose of this study is to evaluate whether bacterial DNA clearance measured with droplet digital Polymerase Chain Reaction (ddPCR) can be used as a measure of bacterial load in septic intensive care patients. Furthermore, the aim is to examine a possible relation between clearance of bacterial DNA and clinical outcome in the septic patient, and the relationship between concentration of beta-lactam antibiotics and the clearance of bacterial DNA.

Condition or disease Intervention/treatment
Septic Shock Sepsis Bacterial Sepsis Diagnostic Test: Blood sampling

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quantification of Bacterial DNA in Septic Intensive Care Patients in Relation to Concentration of Antibiotics and Clinical Outcome: A Prospective Observation Study
Actual Study Start Date : January 7, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort Intervention/treatment
intensive care patients with sepsis
Adult patients with verified or suspected sepsis admitted to the intensive care department from the emergency department
Diagnostic Test: Blood sampling
Blood samples taken every third hour during the first 48 hours of intensive care

Primary Outcome Measures :
  1. Bacterial DNA measured by 16S ddPCR [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Concentration of beta-lactam antibiotics [ Time Frame: 48 hours ]

  2. Lactate clearance [ Time Frame: 48 hours ]
    mmol/L, clearance %

  3. SOFA [ Time Frame: ICU stay up to 30 days ]
    Sequential Organ Failure Assessment score, from 0(normal) to 24(highest organ dysfunction)

  4. Time in assisted ventilation [ Time Frame: ICU stay up to 30 days ]

  5. Need of vasopressors [ Time Frame: ICU stay up to 30 days ]

  6. Days in the ICU [ Time Frame: ICU stay up to 30 days ]

  7. AGI score [ Time Frame: ICU stay up to 30 days ]
    Acute Gastrointestinal Injury Score 0(normal) to 4(life-threatening GI complications)

  8. ICU mortality [ Time Frame: ICU stay up to 30 days ]
    Occurence of death during ICU stay

  9. 28-day mortality [ Time Frame: 28 days ]
    Occurence of death at day 28

  10. Gastrointestinal complications [ Time Frame: 28 days ]
    Occurence of gastrointestinal complications including GI-bleeding, GI-ischemia, pancreatitis and ileus

  11. Intestinal fatty acid binding protein (I-FABP) [ Time Frame: 48 hours ]
    picogram/mL, biomarker of gastrointestinal injury

  12. Citrulline [ Time Frame: 48 hours ]
    nmol/mL, biomarker of gastrointestinal injury

  13. Nuclear DNA [ Time Frame: 48 hours ]

  14. Cytokines (Th1 and Th2 signature panel) [ Time Frame: 48 hours ]

  15. Blood cell populations [ Time Frame: 48 hours ]
    Mean fluorescence intensity/ Antibodies/cell. Monocytes, granulocytes, T-cells, and myeloid derived stem cells including surface markers such as PD-1(Programmed cell death protein 1),PD-L1 (Programmed death ligand 1), and HLA-DR (Human leukocyte Antigen - DR isotype)

  16. HLA-DR messenger RNA (mRNA) [ Time Frame: 48 hours ]
    ratio/reference gene

  17. Procalcitonin [ Time Frame: 48 hours ]

  18. MicroRNA (miRNA) [ Time Frame: 48 hours ]
    Relative expression/ratio reference gene, transcriptomic and quantitative PCR based measurement

Biospecimen Retention:   Samples With DNA
whole blood, serum

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients at the emergency department

Inclusion Criteria:

  1. Adult patient at the emergency department with verified or suspected sepsis and who is in need of intensive care.
  2. Informed Consent by patient or legal representative.
  3. Indication for beta-lactam antibiotics

Exclusion Criteria:

  1. < 18 years
  2. Patients and/or relatives unable to understand study information.
  3. Anaphylactic allergy to beta-lactam antibiotics
  4. Patients already treated with antibiotics

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 identifier (NCT number): NCT03782454

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Contact: Johanna Savilampi, PhD +460196020266
Contact: Karolina Liljedahl Pryz, MD +460196020000

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University Hospital in Örebro Recruiting
Örebro, Sweden, 701 85
Contact: Johanna Savilampi, MD    +46196020266   
Sponsors and Collaborators
Region Örebro County
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Principal Investigator: Jan Källman, PhD Region Örebro County
Principal Investigator: Hans Hjelmqvist, Phd Region Örebro County

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Responsible Party: Region Örebro County Identifier: NCT03782454     History of Changes
Other Study ID Numbers: JS008
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Region Örebro County:
Bacterial DNA clearance
Droplet digital PCR
Betalactam antibiotics
Acute gastrointestinal index

Additional relevant MeSH terms:
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Shock, Septic
Systemic Inflammatory Response Syndrome
Pathologic Processes