Quantification of Bacterial DNA in Sepsis

NCT03782454 | Unknown

• 1 other identifier: JS008
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock; Sepsis Bacterial; Sepsis

Keywords

Bacterial DNA clearance; Droplet digital PCR; Betalactam antibiotics; Acute gastrointestinal index; Cytokines

Outcome Measures

Primary Outcomes (1)

• Bacterial DNA measured by 16S ddPCR

  copies/mL

  48 hours

Secondary Outcomes (18)

• Concentration of beta-lactam antibiotics

  48 hours

• Lactate clearance

  48 hours

• SOFA

  ICU stay up to 30 days

• Time in assisted ventilation

  ICU stay up to 30 days

• Need of vasopressors

  ICU stay up to 30 days

Study Arms (1)

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

Interventions

Blood sampling DIAGNOSTIC_TEST

Blood samples taken every third hour during the first 48 hours of intensive care

intensive care patients with sepsis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients at the emergency department

You may qualify if:

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

You may not qualify if:

• \< 18 years
• Patients and/or relatives unable to understand study information.
• Anaphylactic allergy to beta-lactam antibiotics
• Patients already treated with antibiotics

Sponsors & Collaborators

• Region Örebro County: lead

Study Sites (1)

University Hospital in Örebro

Örebro, 701 85, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum

MeSH Terms

Conditions

Shock, Septic; Sepsis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jan Källman, PhD

  Region Örebro County

  PRINCIPAL INVESTIGATOR

• Hans Hjelmqvist, Phd

  Region Örebro County

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johanna Savilampi, PhD

CONTACT

+460196020266; johanna.savilampi@regionorebrolan.se

Karolina Liljedahl Pryz, MD

CONTACT

+460196020000; karolina.liljedahl.pryz@regionorebrolan.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 20, 2018
• Study Start: January 7, 2019
• Primary Completion: December 31, 2021
• Study Completion: May 31, 2022
• Last Updated: January 29, 2019

Record last verified: 2018-12

Locations

SE (1)