Bispectral-Electroencephalography (EEG) in First Time Hemodialysis

Last updated: December 1, 2024
Sponsor: Suez Canal University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Nephropathy

Kidney Disease

Renal Failure

Treatment

recording of Bispectral Index

Clinical Study ID

NCT03276273
MUGraz7
  • Ages 18-90
  • All Genders

Study Summary

The severity of minimal dialysis disequilibrium syndrome (DDS) is currently detected and graded clinically using clinical criteria. Bispectral Index (BIS), an electroencephalographic (EEG) derived parameter is widely used in anesthesia and Critical Care setting to detect effects of anesthetic/hypnotic drugs. The aim of our study was to assess the discriminative power of BIS monitoring to accurately detect DDS.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • First Time renal Dialysis

Exclusion

Exclusion Criteria:

  • subjects' consumption of sedatives/hypnotics psychotropic drugs, or concomitantneurological disorders affecting mental state such as hepatic encephalopathy,stroke, stupor or dementia and renal transplant patients.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: recording of Bispectral Index
Phase:
Study Start date:
May 01, 2017
Estimated Completion Date:
December 01, 2027

Study Description

Design: A consecutive, clinical, validation study. Setting: Medical University of Graz (Graz, Austria). Patients: Twenty consecutive patients undergoing first hemodialysis are enrolled at Medical University of Graz, Haemodialysis Unit. Agitated patients or patients who fell asleep during the recording are excluded from the final analysis.

During the first dialysis session of approximately 3 h, patients were observed for signs of disequilibrium; headaches, dizziness, nausea, vomiting, if they become obtunded, have visual impairments or cramps. Accordingly patients were divided into 2 groups; the "DDS group" of patients who experienced one of the DDS symptoms of headaches, dizziness, nausea, vomiting, become obtunded, have visual impairments or cramps and patients who do not experience any of the DDS symptoms in the "non-DDS group" An assigned nephrologist will assess the physical and mental status of the patients.

Connect with a study center

  • Medical University of Graz

    Graz, 8046
    Austria

    Site Not Available

  • Dalian Medical University

    Dalian,
    China

    Active - Recruiting

  • Theodor Bilharz Research Institute

    Cairo, 8046
    Egypt

    Active - Recruiting

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