NCT03870594

Brief Summary

Intradialytic hypotension (IDH ) is a serious and the most frequent complication of hemodialysis of the hemodialysis .Diabetes is associated with autonomic neuropathy which contribute to intradialytic hypotension

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

March 5, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

2 months

First QC Date

March 5, 2019

Last Update Submit

March 8, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • the correlation between diabetes and intradialytic hypotension

    Blood samples will be obtained for glycated hemoglobin, fasting blood glucose.Then patients will be divided into two groups DM, non DM. Blood pressure will be measured with mercury sphygmomanometer before, after and every 60 min during the hemodialysis session (a total of 5 measurements), for 10 consecutive dialysis sessions.Intradialytic hypotension (IDH) will defined as a decrease in systolic BP by ≥20 mm Hg or a decrease in mean arterial pressure of 10 mm Hg associated with symptoms

    4 weeks

  • the correlation between dialytic age and intradialytic hypotension

    Prior to the dialysis session,full history taking including age,duration of haemodialysis Blood pressure (BP) will be measured with mercury sphygmomanometer before, after and every 60 min during the hemodialysis session (a total of 5 measurements), for 10 consecutive dialysis sessions. Intradialytic hypotension (IDH) will defined as a decrease in systolic BP by ≥20 mm Hg or a decrease in mean arterial pressure of 10 mm Hg associated with symptoms

    4 weeks

Study Arms (2)

diabetic

patients suffer from diabetes mellitus

Diagnostic Test: glycated hemoglobin

non diabetic

patients free from diabetes with normal blood glucose level

Diagnostic Test: glycated hemoglobin

Interventions

glycated hemoglobinDIAGNOSTIC_TEST

hemoglobin A1c level in blood

diabeticnon diabetic

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all haemodialysed end stage kidney disease patients of the haemodialysis unit in Assiut health insurance hospital

You may qualify if:

  • All haemodialysed end stage kidney disease patients of the haemodialysis unit in Assiut health insurance hospital

You may not qualify if:

  • Advanced heart failure 2-Clinical instability requiring hospital admission. 3-History of alcohol or substance abuse 4-previous history of psychotic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Essam Abd El Mohsen

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
resident doctor at health insurance hospital ,Assiut, Egypt

Study Record Dates

First Submitted

March 5, 2019

First Posted

March 12, 2019

Study Start

April 1, 2019

Primary Completion

June 1, 2019

Study Completion

July 1, 2019

Last Updated

March 12, 2019

Record last verified: 2019-03