Bispectral-Electroencephalography (EEG) in First Time Hemodialysis

Recruiting

• Conditions: Renal Failure Acute Chronic

• Registration Number: NCT03276273
• Lead Sponsor: Suez Canal University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2017-09-02
• Study First Submitted QC: 2017-09-06
• Study First Posted: 2017-09-08
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-01
• Last Update Posted: 2024-12-04
• Primary Completion: 2027-12-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the Bispectral Index value	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)

Trial Locations

Locations (2)

Dalian Medical University; 🇨🇳 Dalian, China

Theodor Bilharz Research Institute; 🇪🇬 Cairo, Egypt