The Dynamic Change of MMN in Patients With Sepsis Associated Encephalopathy

NCT04870983 | Unknown DMC

• 1 other identifier: MMN in SAE
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Sepsis-associated encephalopathy (SAE), is one of the most common organ dysfunction during the acute phase in sepsis and septic shock. Electroencephalogram (EEG) and auditory evoked potentials (AEPs), which reflect different aspects of brain function, are the most commonly used neurophysiological indices to detect acute brain dysfunction in critically ill patients including sepsis and septic shock. AEPs show the systemic responsiveness of the central nervous to auditory stimuli, so they can be considered a direct measure of brain responsiveness. Mismatch negativity (MMN) is a change-specific component of ERPs, which elicited by a deviant stimulus occurring in a sequence of repetitive stimuli. This component is thought to represent the automatic and unconscious detection of acoustic changes which requires good perceptual discriminative capacity and iconic memory. The peaks of MMN appear at 100 \~ 250 ms from deviant stimulus onset; with increasing magnitude of stimulus change, the peak latency of MMN was shortened and the amplitude increased. Since MMN can be elicited even in the absence of attention, subjects do not need to actively participate. The MMN has been extensively demonstrated to be used in the prediction of awakening in comatose patients for various reasons, and also has been reported to predict awakening in deeply sedated critically ill patients recently. However, it remains unclear whether SAE affects MMN in amplitude and latency that reflects cognitive processing of the auditory information. Patients with sepsis and septic shock who met the inclusion criteria were screened daily on the CAM-ICU scale, and those with positive CAM-ICU were diagnosed with SAE.All patients were tested for event-evoked potentials on Day 1 and Day 3 after inclusion and were followed up to Day 28 after discharge. The investigators intend to observe the dynamic change of MMN amplitude and latency between SAE and non-SAE groups. Logic regression analysis was used to determine whether the change of MMN was a predictor of SAE.

Conditions

Sepsis-Associated Encephalopathy; Mismatch Negativity

Outcome Measures

Primary Outcomes (2)

• the dynamic change of mismatch negativity(MMN) amplitude

  μv

  Day 1 and day 3 after admission

• the dynamic change of MMN incubation period

  ms

  Day 1 and day 3 after admission

Secondary Outcomes (3)

• Burst suppression

  Day 1 and day 3 after admission

• Periodic discharges

  Day 1 and day 3 after admission

• Normal background

  Day 1 and day 3 after admission

Study Arms (2)

SAE group

SAE was defined as cerebral dysfunction in the presence of sepsis or septic shock and the absence of any of the exclusion criteria. For patients undergoing sedation during the ICU stay, the GCS scores were evaluated before sedation; for patients who have been sedated prior to ICU admission, the assumed GCS scores, i.e., the scores measured before any administration of sedative/relaxant drug were used for analysing; for postoperative patients, the GCS scores measured before surgery was used. The CAM-ICU was assessed daily by the nurse or the physician in charge of the patient during the ICU stay. For patients who were sedated, spontaneous awakening trials were performed daily; the longest evaluate time after withdrawal of sedation was 24 h during the trials. In this evaluation period, patients should be awake to evaluate their consciousness, and they were diagnosed of SAE if the patients were not awake.

non-SAE group

The patient was diagnosed with sepsis or septic shock but could not be diagnosed with SAE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with confirmed sepsis or septic shock

You may qualify if:

• ages between 18 and 80 years;
• expected stay in the ICU of \> 72 h;
• patients diagnosed with sepsis or septic shock;
• informed consent was signed by the patient or relatives;

You may not qualify if:

• at terminal stage of disease;
• primary brain injury (such as traumatic brain injury, stroke, cardiac arrest, intracranial infection, epilepsy, Alzheimer's disease, Parkinson disease and meningitis etc.);
• acute mental deterioration secondary to non-septic metabolic disorders with organ dysfunction (hepatic encephalopathy, pulmonary encephalopathy, severe electrolyte imbalance, severe blood glucose disorders etc.);
• history of craniocerebral surgery;
• psychiatric illness;
• use of psychiatric medications;
• impaired hearing; participated in other clinical trial;
• pregnant or lactating women;
• expected death within 72 h after admission.

Sponsors & Collaborators

• Chinese Medical Association: lead

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

Related Publications (3)

• Cotena S, Piazza O. Sepsis-associated encephalopathy. Transl Med UniSa. 2012 Jan 18;2:20-7. Print 2012 Jan.

  PMID: 23905041 RESULT

• Azabou E, Rohaut B, Porcher R, Heming N, Kandelman S, Allary J, Moneger G, Faugeras F, Sitt JD, Annane D, Lofaso F, Chretien F, Mantz J, Naccache L, Sharshar T; GENeR** (Groupe d'Explorations Neurologiques en Reanimation). Mismatch negativity to predict subsequent awakening in deeply sedated critically ill patients. Br J Anaesth. 2018 Dec;121(6):1290-1297. doi: 10.1016/j.bja.2018.06.029. Epub 2018 Sep 4.

  PMID: 30442256 RESULT

• Rinaldi S, Consales G, De Gaudio AR. Changes in auditory evoked potentials induced by postsurgical sepsis. Minerva Anestesiol. 2008 Jun;74(6):245-50. Epub 2008 Apr 30.

  PMID: 18438333 RESULT

MeSH Terms

Conditions

Sepsis-Associated Encephalopathy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Wenkui Yu, M.D.

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  STUDY DIRECTOR

Central Study Contacts

Beiyuan Zhang, M.S.

CONTACT

+86-025-83106666-40400; 1083537599@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: May 4, 2021
• Study Start: February 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: May 4, 2021

Record last verified: 2021-04

Locations

CN (1)