Using EEG to detect dialysis disequilibrium syndrome in first-time hemodialysis patients
The Utility of Using the Bispectral Index (BIS) for Detecting Dialysis Disequilibrium Syndrome (DDS)
This study is testing if a special brain wave monitor can help identify dialysis disequilibrium syndrome in people who are having their first hemodialysis treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Suez Canal University Academic / other |
| Locations | 2 sites (Dalian and 1 other locations) |
| Trial ID | NCT03276273 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of Bispectral Index (BIS) monitoring, derived from electroencephalography (EEG), in identifying dialysis disequilibrium syndrome (DDS) in patients undergoing their first hemodialysis session. Conducted at the Medical University of Graz, the study involves 20 patients who will be monitored for symptoms of DDS during a 3-hour dialysis session. Patients will be categorized into two groups based on the presence or absence of DDS symptoms, allowing for a comparative analysis of BIS readings. The study seeks to validate BIS as a reliable tool for detecting DDS in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are patients undergoing their first hemodialysis treatment.
Not a fit: Patients with neurological disorders or those taking sedatives or psychotropic drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accurate and objective method for detecting dialysis disequilibrium syndrome, potentially improving patient outcomes during hemodialysis.
How similar studies have performed: While the use of BIS monitoring in anesthesia is well-established, its application in detecting DDS is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Dalian and 1 other locations
- Dalian Medical University — Dalian, China (Recruiting)
- Theodor Bilharz Research Institute — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Ashraf Dahaba, MD — Guest Professor
- Study coordinator: Ashraf Dahaba, MD
- Email: ashraf.dahaba@medunigraz.at
- Phone: 00436509006761
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.