Epidemiology and Outcomes of Gram Negative Urosepsis

NCT02380170 | Completed

• 1 other identifier: 2014-01
• Study Type: observational
• Target: 600
• Locations: 6 countries
• Sites: 6

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.

Conditions

Urosepsis

Keywords

sepsis; urinary tract infection; resistance; pathogens; mortality; health economics

Outcome Measures

Primary Outcomes (1)

• Number of patients with each causative pathogens and their susceptibility profile at the baseline evaluation (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).

  initial diagnosis of urosepsis

Secondary Outcomes (4)

• Hospital Costs (Euros) of each patients Urosepsis management

  Duration of Hospitalisation (basline evaluation to discharge of patient or death)

• All cause mortality

  First 30 days from diagnosis

• Morbidity

  First 30 days from diagnosis (baseline)

• Health related Quality of Life

  Baseline, Follow-up (3rd, 7th, 9th and 30th day after baseline)

Study Arms (1)

Urosepsis

Sepsis derived from the urinary tract infection

Eligibility Criteria

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

You may qualify if:

• 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:
• Hypothermia by core temperature \<36ºC, or hyperthermia \>38ºC measured via any means
• Heart rate (HR) \>90 beats per minute
• 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
• 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

You may not qualify if:

• Sepsis due to other causes besides the urogenital tract.

Sponsors & Collaborators

• European Association of Urology Research Foundation: lead

Study Sites (7)

South-Pest Teaching Hospital

Budapest, Hungary

Location

Manzoni Hospital

Lecco, 23900, Italy

Location

University Clinic of Surgery " St. Naum Ohridski"

Skopje, 1000, North Macedonia

Location

Oslo University Hospital

Oslo, Norway

Location

Nicolaus Copernicus City Hospital

Torun, 87-100, Poland

Location

Centro Hospitalar Cova da Beira

Lisbon, Portugal

Location

GOP Taksim Teaching Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• Angus DC, Wax RS. Epidemiology of sepsis: an update. Crit Care Med. 2001 Jul;29(7 Suppl):S109-16. doi: 10.1097/00003246-200107001-00035.

  PMID: 11445744 BACKGROUND

• Tandogdu Z, Cek M, Wagenlehner F, Naber K, Tenke P, van Ostrum E, Johansen TB. Resistance patterns of nosocomial urinary tract infections in urology departments: 8-year results of the global prevalence of infections in urology study. World J Urol. 2014 Jun;32(3):791-801. doi: 10.1007/s00345-013-1154-8. Epub 2013 Aug 24.

  PMID: 23979151 BACKGROUND

• Tandogdu Z, Koves B, Ristovski S, Balci MBC, Rennesund K, Gravas S, Nale D, Medina-Polo J, Garabasova MK, Costantini E, Cano-Valasco J, Glavinova MS, Bruyere F, Perepanova T, Kulchavenya E, Cek M, Wagenlehner F, Johansen TEB; SERPENS Investigators. Urosepsis 30-day mortality, morbidity, and their risk factors: SERPENS study, a prospective, observational multi-center study. World J Urol. 2024 May 10;42(1):314. doi: 10.1007/s00345-024-04979-2.

  PMID: 38730089 DERIVED

Related Links

• Study webpage

MeSH Terms

Conditions

Sepsis; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Truls Erik Bjerklund Johansen, Prof.

  Oslo Univeristy, Norway

  STUDY CHAIR

• Florian Wagenlehner, Prof.

  Giessen Univeristy, Germany

  STUDY CHAIR

• Zafer Tandogdu, MD

  Northern Institute for Cancer Research, Newcastle University, UK

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: March 5, 2015
• Study Start: September 1, 2014
• Primary Completion: August 24, 2018
• Study Completion: May 24, 2020
• Last Updated: August 7, 2020

Record last verified: 2020-08

Locations

HU (1); NO (1); IT (1); PT (1); PL (1); TU (1)