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NCT Number: NCT03276273

Bispectral-Electroencephalography (EEG) in First Time Hemodialysis

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dalian Medical University, Dalian, China

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • First Time renal Dialysis

Exclusion criteria

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

Treatment and study plan

recording of Bispectral Index

Device

recording of Bispectral Index

Primary outcomes

  1. Change in the Bispectral Index value

    Time frame: Over a period of one year Time point 1= First Hemodialysis, Time point 2= Second Hemodialysis, Time point 3= Third Hemodialysis.

    Interpatient Change in the value of recorded Bispectral Index between patients undergoing first time hemodialysis (differences between patients) and intrapatient (differences in bispectral Index values between the first 3 hemodialysis sections of each recruited patient)

Study contacts

Contact information is provided by the study sponsor or research team.

Ashraf Dahaba, MD

CONTACT

[email protected]

00436509006761

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Collaborators

  • Dalian Medical University

Registry information

Official study title

The Utility of Using the Bispectral Index (BIS) for Detecting Dialysis Disequilibrium Syndrome (DDS)

Acronym: BIS7

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Sep 8, 2017
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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