CompletedNot Applicable

Epidemiology and Outcomes of Gram Negative Urosepsis

Hungary, Italy, North Macedonia600 participantsStarted 2014-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: initial diagnosis of urosepsis

Trial details

NCT IDNCT02380170

SponsorEuropean Association of Urology Research Foundation

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-08-24

View on ClinicalTrials.gov More Urosepsis trials