Renal Failure Acute ChronicBIS7NCT03276273
Bispectral-Electroencephalography (EEG) in First Time Hemodialysis
An observational study of Renal Failure Acute Chronic, run by Suez Canal University at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Renal Failure Acute Chronic
- What is being tested?
- recording of Bispectral Index
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 May 2017to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: First Time renal Dialysis
Who may be able to join
- First Time renal Dialysis
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
China1 site, 1 recruiting
- Recruiting
Dalian Medical University
Dalian
Ashraf Dahaba, +436509006761 ext. +436509006761
Zhaoyang Xiao
Egypt1 site, 1 recruiting
- Recruiting
Theodor Bilharz Research Institute
Cairo, 8046
Ashraf M Dahaba, MD, +436509006761 ext. +436509006761
About this study
Official title: The Utility of Using the Bispectral Index (BIS) for Detecting Dialysis Disequilibrium Syndrome (DDS)
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.
Read the 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.
- Conditions
- Renal Failure Acute Chronic
- Being tested
- recording of Bispectral Index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recording of Bispectral IndexDevice
recording of Bispectral Index
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Over a period of one year Time point 1= First Hemodialysis, Time point 2= Second Hemodialysis, Time point 3= Third Hemodialysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start1 May 2017
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Failure Acute ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Collaborators
- Dalian Medical University
- Responsible party
- Principal investigator, Ashraf A. Dahaba, Suez Canal University
- Investigators
- Ashraf Dahaba, MD, Principal investigator, Guest Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276273
- Sponsor's protocol ID
- MUGraz7
- Acronym
- BIS7
- Status last verified
- Apr 2026
- First submitted
- 2 Sep 2017
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Using the Bispectral Index (BIS) for Detecting Dialysis Disequilibrium Syndrome (DDS)
- ClinicalTrials.gov ID
- NCT03276273
- Acronym / sponsor ID
- BIS7 / MUGraz7
- Conditions
- Renal Failure Acute Chronic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Collaborators
- Dalian Medical University
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 8 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- First Time renal Dialysis
Key inclusion criteria (1 listed)
- First Time renal Dialysis
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recording of Bispectral Indexrecording of Bispectral Index | Device | – |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashraf Dahaba, MD principal investigator
Guest Professor
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Failure Acute Chronic, run by Suez Canal University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashraf Dahaba, MD (00436509006761, ashraf.dahaba@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.