Bispectral-Electroencephalography (EEG) in First Time Hemodialysis

Renal Failure Acute Chronic Clinical Trial

— BIS7  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03276273
• Other study ID #: MUGraz7
• Status: Recruiting
• Start date: May 1, 2017
• Est. completion date: December 1, 2025

Study information

• Verified date: November 2023
• Source: Suez Canal University
• Contact: Ashraf Dahaba, MD
• Phone: 00436509006761
• Email: ashraf.dahaba[@]medunigraz.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Renal Failure Acute Chronic
• Renal Insufficiency

Intervention

Device:
• recording of Bispectral Index
recording of Bispectral Index

Locations

Country	Name	City	State
China	Dalian Medical University	Dalian
Egypt	Theodor Bilharz Research Institute	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Suez Canal University	Dalian Medical University

Countries where clinical trial is conducted

China,  Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Bispectral Index value	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)	Over a period of one year Time point 1= First Hemodialysis, Time point 2= Second Hemodialysis, Time point 3= Third Hemodialysis.