NCT06808152

Brief Summary

The aim of the study is to assess the correlation of QTc interval and sudden cardiac arrest in hemodialysis patients to the different dialysate calcium concentrations.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
18mo left

Started Mar 2025

Typical duration for all trials

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Mar 2025Dec 2027

First Submitted

Initial submission to the registry

January 29, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
24 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

February 5, 2025

Status Verified

October 1, 2024

Enrollment Period

1.8 years

First QC Date

January 29, 2025

Last Update Submit

January 29, 2025

Conditions

Keywords

QTc intervaldialysate calcium concentarions

Outcome Measures

Primary Outcomes (1)

  • Q-T interval changes in hemodialysis patient

    cardiac electrical stability during hemodialysis treatment

    6 weeks

Study Arms (1)

hemodialysis patients

patients on regular hemodialysis for not less than one year with age above 20 years \& less than 60 . patients will be studied on two sessions of hemodialysis with different dialysate calcium concentrations, one by bicarbonate dialysate with calcium concentration 1.25 mmol/L, and bicarbonate dialysate with calcium concentration 1.5 mmol/L.

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

patients on regular hemodialysis for not less than one year with age above 20 years \& less than 60 . patients will be studied on two sessions of hemodialysis with different dialysate calcium concentrations, one by bicarbonate dialysate with calcium concentration 1.25 mmol/L, and bicarbonate dialysate with calcium concentration 1.5 mmol/L.

You may qualify if:

  • patients with End Stage Kidney Disease (ESKD) on regular hemodialysis (HD), for not less than one year with age above 20 years \& less than 60.

You may not qualify if:

  • Patients with multi- systemic diseases as SLE Patient with organ damage as heart failure, ischemic heart disease, decompensated liver disease \& CVS Patients with organ transplantation Malignancy Patients above 60 years \& below 20 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Ashraf gad Ahmed Ataia, residant doctor

CONTACT

Study Design

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

Study Record Dates

First Submitted

January 29, 2025

First Posted

February 5, 2025

Study Start

March 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 30, 2027

Last Updated

February 5, 2025

Record last verified: 2024-10