Neurological Outcome in Surgical and Non-surgical Septic Patients

NCT02442986 | Completed

• 1 other identifier: URostock
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critical-Illness; Polyneuropathy; Myopathy; Septic Encephalopathy

Keywords

weaning failure; polyneuropathy; encephalopathy; sepsis

Outcome Measures

Primary Outcomes (4)

• Septic Encephalopathy

  EEG, MRT, CSF (cerebrospinal fluid)

  day 7

• Critical-Illness-Polyneuropathy and -myopathy

  ENG

  day 7

• Septic Encephalopathy (28)

  Clinical observation.

  day 28

• Critical-Illness-Polyneuropathy and -myopathy (28)

  Clinical observation.

  day 28

Secondary Outcomes (4)

• - 28-day survival (observation time 100 days)

  day 28

• - Time of respirator-therapy

  1 year

• - Dosage of vasopressors (cumulative)

  observation time 100 days

• - 100 day survival

  day 100

Study Arms (3)

Septic Shock or severe sepsis

Septic patients on ICU with severe sepsis or septic shock.

Non-Septic, Surgical Patients

Non-septic patients after surgical treatment and anesthesia on ICU.

Non-Septic, Non-Surgical Patients

Patients without sepsis criteria treated on ICU, non-surgical patients.

Eligibility Criteria

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

Study Population

All patients with severe sepsis and septic shock and fulfilling the inclusion criteria should be screened for the study on two surgical (septic surgical patients), one medical intensive care unit (septic non-surgical patients) and one neurological intensive care unit (non-septic patients) at the university hospital of Rostock, Germany.

You may qualify if:

• Fulfilling criteria for severe sepsis or septic shock

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Rostock: lead

Study Sites (1)

Intensive Care Units PIT 1+2, University hospital Rostock

Rostock, 18055, Germany

Location

Related Publications (1)

• Ehler J, Barrett LK, Taylor V, Groves M, Scaravilli F, Wittstock M, Kolbaske S, Grossmann A, Henschel J, Gloger M, Sharshar T, Chretien F, Gray F, Noldge-Schomburg G, Singer M, Sauer M, Petzold A. Translational evidence for two distinct patterns of neuroaxonal injury in sepsis: a longitudinal, prospective translational study. Crit Care. 2017 Oct 23;21(1):262. doi: 10.1186/s13054-017-1850-7.

  PMID: 29058589 DERIVED

MeSH Terms

Conditions

Critical Illness; Polyneuropathies; Muscular Diseases; Sepsis-Associated Encephalopathy; Brain Diseases; Sepsis

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Diseases; Central Nervous System Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation

Study Officials

• Martin Sauer, MD

  University of Rostock

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 29, 2015
• First Posted: May 13, 2015
• Study Start: November 1, 2012
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 20, 2017

Record last verified: 2017-04

Locations

DE (1)