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Bispectral-Electroencephalography (EEG) in First Time Hemodialysis

NCT ID: NCT03276273

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2027-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Renal Failure Acute Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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recording of Bispectral Index

recording of Bispectral Index

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dalian Medical University

OTHER

Sponsor Role collaborator

Suez Canal University

OTHER

Sponsor Role lead

Responsible Party

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Ashraf A. Dahaba

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ashraf Dahaba, MD

Role: PRINCIPAL_INVESTIGATOR

Guest Professor

Locations

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Dalian Medical University

Dalian, , China

Site Status RECRUITING

Theodor Bilharz Research Institute

Cairo, , Egypt

Site Status RECRUITING

Countries

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China Egypt

Central Contacts

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Ashraf Dahaba, MD

Role: CONTACT

[email protected]
00436509006761

Facility Contacts

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Ashraf Dahaba

Role: primary

+436509006761 ext. +436509006761

Zhaoyang Xiao

Role: backup

Ashraf M Dahaba, MD

Role: primary

+436509006761 ext. +436509006761

Other Identifiers

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MUGraz7

Identifier Type: -

Identifier Source: org_study_id