NCT03276273

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
19mo left

Started May 2017

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
May 2017Dec 2027

Study Start

First participant enrolled

May 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 8, 2017

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

10.6 years

First QC Date

September 2, 2017

Last Update Submit

April 22, 2026

Conditions

Renal Failure Acute Chronic

Outcome Measures

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)

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

Interventions

recording of Bispectral IndexDEVICE

recording of Bispectral Index

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

First Time renal Dialysis

You may qualify if:

  • First Time renal Dialysis

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dalian Medical University

Dalian, China

RECRUITING

Theodor Bilharz Research Institute

Cairo, 8046, Egypt

RECRUITING

Study Officials

  • Ashraf Dahaba, MD

    Guest Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashraf Dahaba, MD

CONTACT

00436509006761ashraf.dahaba@medunigraz.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 2, 2017

First Posted

September 8, 2017

Study Start

May 1, 2017

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)CN(1)