CompletedNot Applicable

Neurological Outcome in Surgical and Non-surgical Septic Patients

Germany32 participantsStarted 2012-11

Plain-language summary

Systemic inflammation and sepsis cause multi organ failure including severe neurologic impairment in the course of disease. Neurologic failure typically presents as critical-illness-polyneuropathy/-myopathy and septic encephalopathy during sepsis and is associated with an increased mortality rate. Clinical parameters to determine the neurologic entities during the course of sepsis are heterogeneous. Further research for an association of clinical parameters and the patients' outcome is needed. The study aims toward differences in the clinical and neurological outcome of surgical and non-surgical septic patients in comparison to non-septic patients on ICU. The aim of the study is to identify clinical and diagnostic outcome predictors in septic patients.

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: * Fulfilling criteria for severe sepsis or septic shock Exclusion Criteria: * Diagnosis of cerebrovascular disease (pre-existing) * Advanced dementia * Diagnosis of pre-existing other neuromuscular disease * High-dose glucocorticosteroid therapy (\> 300 mg Hydrocortisone/die) * Pre-existing renal replacement therapy * Coagulation disorder with bleeding * Frequent administration of neuromuscular blocking agents (\> 3 times/week)

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

Septic Encephalopathy

Timeframe: day 7

Critical-Illness-Polyneuropathy and -myopathy

Timeframe: day 7

Septic Encephalopathy (28)

Timeframe: day 28

Critical-Illness-Polyneuropathy and -myopathy (28)

Timeframe: day 28

Trial details

NCT IDNCT02442986

SponsorUniversity of Rostock

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-03

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