ClinicalTrials.gg
RecruitingNCT03276273BIS7Updated Apr 28, 2026

Bispectral-Electroencephalography (EEG) in First Time Hemodialysis

An observational study in Renal Failure Acute Chronic, sponsored by Suez Canal University. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-04-28.

Sponsored by Suez Canal University · Observational

From the registry’s dates

  • Started May 2017; still recruiting 9 years 6 months later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 90 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 168 studies in Acute Kidney Injury with a site in China — 46 open to participants now, 54 under way, 1 of them phase 3. Acute Kidney Injury · China.

Planned enrollment
102nd of 105
20 · median 472
Started
2017
with 7 others
Observational
105 of 168
26 open now
Primary completion
2027-12
later than 40 of 53 live
Registered
31st of 168
by date

Among the 168 studies in Acute Kidney Injury with a site in China, this one is the 102nd largest by planned enrollment of the 105 observational ones that give a count, is one of 8 that started in 2017, is one of 105 observational ones, reaches primary completion later than 40 of the 53 other live ones, and was the 31st registered.

Acute Kidney Injury

1,691 studies on the registry are indexed under Acute Kidney Injury; 393 are open to participants now.

Browse Acute Kidney Injury studies →

Open to participants now

46 of the 168 studies in Acute Kidney Injury with a site in China are open now. Recruiting first, the newest first:

41 more — sign in →

All 46 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 230 Acute Kidney Injury studies recruiting now, 162 (70%) set no upper age limit and 35 (15%) stop at 75 or younger; 22 take children under 18; 25 take healthy volunteers.

This study: 18 Years to 90 Years · all sexes.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 168 studies in Acute Kidney Injury with a site in China, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Renal Failure Acute Chronic

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04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

First Time renal Dialysis

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Inclusion criteria

  • First Time renal Dialysis

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Interventions

  • Devicerecording of Bispectral Index

    recording of Bispectral Index

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Over a period of one year Time point 1= First Hemodialysis, Time point 2= Second Hemodialysis, Time point 3= Third Hemodialysis.

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2017 (actual). Primary completion is estimated for Dec 2027, 127 months after the start.

Of 350 non-industry observational studies under Acute Kidney Injury, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's planned 127 months is above that.

Counting every sponsor, half of 365 studies reached it within 24 months; a quarter within 12 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 2, 2017
First posted
Sep 8, 2017
StartActual
May 1, 2017
Primary completionEst.
Dec 1, 2027
CompletionEst.
Dec 1, 2027
Last update
Apr 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03276273
Collaborators
Dalian Medical University
Responsible party
Ashraf A. Dahaba (Principal Investigator, Suez Canal University) — Principal investigator
First posted
Sep 8, 2017
Start date
May 1, 2017
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Apr 28, 2026

Study contacts

Ashraf Dahaba, MD
Contact
ashraf.dahaba@medunigraz.at
00436509006761
Ashraf Dahaba, MD
principal investigator · Guest Professor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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