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Epidemiology and Outcomes of Gram Negative Urosepsis (SERPENS)

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ClinicalTrials.gov Identifier: NCT02380170
Recruitment Status : Completed
First Posted : March 5, 2015
Last Update Posted : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
European Association of Urology Research Foundation

Brief Summary:
The study aims to get an insight on the causative bacteria of sepsis derived from the urinary tract. Furthermore, it is the intention to understand the outcomes of these patients. For this purpose a non-interventional, observational study will be conducted.

Condition or disease
Urosepsis

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Epidemiology and Outcomes of Gram Negative Urosepsis
Study Start Date : September 2014
Actual Primary Completion Date : August 24, 2018
Actual Study Completion Date : May 24, 2020

Group/Cohort
Urosepsis
Sepsis derived from the urinary tract infection



Primary Outcome Measures :
  1. Number of patients with each causative pathogens and their susceptibility profile at the baseline evaluation (diagnosis of urosepsis) [ Time Frame: initial diagnosis of urosepsis ]
    Analysis results of microbiological cultures will be used to group them according to the definitions suggested by the ECDC as multi-drug resistant (MDR), extensive drug resistant (XDR) and pan-drug resistant (PDR).


Secondary Outcome Measures :
  1. Hospital Costs (Euros) of each patients Urosepsis management [ Time Frame: Duration of Hospitalisation (basline evaluation to discharge of patient or death) ]
  2. All cause mortality [ Time Frame: First 30 days from diagnosis ]
    Mortality will be captured and the reason of death will also be recorded

  3. Morbidity [ Time Frame: First 30 days from diagnosis (baseline) ]
    Development of organ failure i. Kidney failure ii. Cardiovascular failure iii. Pulmonary failure iv. Hepatic failure v. Ileus vi. Thrombocytopenia

  4. Health related Quality of Life [ Time Frame: Baseline, Follow-up (3rd, 7th, 9th and 30th day after baseline) ]
    EQ-5D questionnaire



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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:   Non-Probability Sample
Study Population
The population to be observed will be adults patients with clinical diagnosis of urosepsis. Observations will be inititated when a patient is diagnosed with urosepsis based on the clinical symptoms and findings as part of routine clinic practice through emergency and accident, urology or internal medicine units.
Criteria

Inclusion Criteria:

  • Microbiologically proven UTI
  • Age>18
  • Patients must meet at least two of the following four SIRS criteria, at least one of which must be the core temperature criterion or the WBC criterion; these criteria did not have to be met simultaneously:

    1. Hypothermia by core temperature <36ºC, or hyperthermia >38ºC measured via any means
    2. Heart rate (HR) >90 beats per minute
    3. Respiratory rate (RR) >20 breaths/minute related to septic event, or partial pressure of arterial carbon dioxide (PaCO2) <32 mmHg related to septic event or requiring mechanical ventilation related to septic event
    4. Total WBC absolute count >12,000 cells/mm3 presence of granulocyte-stimulating factor, for those patients whose WBC absolute count was >12,000 cells/mm3 one other criterion (RR or HR) or <4000 cells/mm3. In the , they must have had a fever and at least

Exclusion Criteria:

  • Sepsis due to other causes besides the urogenital tract.

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): NCT02380170


Locations
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Hungary
South-Pest Teaching Hospital
Budapest, Hungary
Italy
Manzoni Hospital
Lecco, Italy, 23900
North Macedonia
University Clinic of Surgery " St. Naum Ohridski"
Skopje, North Macedonia, 1000
Norway
Oslo University Hospital
Oslo, Norway
Poland
Nicolaus Copernicus City Hospital
Torun, Poland, 87-100
Portugal
Centro Hospitalar Cova da Beira
Lisbon, Portugal
Turkey
GOP Taksim Teaching Hospital
Istanbul, Turkey
Sponsors and Collaborators
European Association of Urology Research Foundation
Investigators
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Study Chair: Truls Erik Bjerklund Johansen, Prof. Oslo Univeristy, Norway
Study Chair: Florian Wagenlehner, Prof. Giessen Univeristy, Germany
Study Director: Zafer Tandogdu, MD Northern Institute for Cancer Research, Newcastle University, UK
Additional Information:
Publications:
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Responsible Party: European Association of Urology Research Foundation
ClinicalTrials.gov Identifier: NCT02380170    
Other Study ID Numbers: 2014-01
First Posted: March 5, 2015    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020
Keywords provided by European Association of Urology Research Foundation:
sepsis
urinary tract infection
resistance
pathogens
mortality
health economics