NCT06695923

Brief Summary

Finding relationship between different ultrafiltration rates and intradialytic hypotension in attempt to find the optimal cut off points.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 15, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
2 months until next milestone

Results Posted

Study results publicly available

March 2, 2026

Completed
Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

10 months

First QC Date

November 15, 2024

Results QC Date

January 9, 2026

Last Update Submit

February 10, 2026

Conditions

Keywords

Ultrafiltration ratesIntradialytic hypotension

Outcome Measures

Primary Outcomes (2)

  • Prevent Intradialytic Hypotension

    Finding the optimal threshold of ultrafiltration rates to prevent intradialytic hypotension through observing the risk factors associated with the occurrence of HDH

    6 month

  • Clinical History Among the Study Patients.

    Analysis of the prevalence of chronic illness among the study participants, as well as the number of antihypertensive drugs used.

    6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hemodialysis patients more than 18 year old on maintenance hemodialysis receiving 3 sessions weekly.

You may qualify if:

  • All patients aged 18 Year or older on maintenance haemodialysis for at least 3 consecutive months receiving 3 sessions weekly.

You may not qualify if:

  • Patients aged \< 18 years old.
  • Patients on recent haemodialysis \< 3 months.
  • Pregnant women.
  • Patients with malignancy, severe infections or sepsis.
  • Patients with major bleeding.
  • Patients who cannot go upper limb monitoring of blood pressure.
  • Patients with severe heart failure (NYHA) class 3 or more.
  • Patients with severe anemia, Hemoglobin less than 6 g/dl.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospitals,Faculty of medicine

Sohag, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

CBC Serum albumin

Results Point of Contact

Title
Dr. Marwa Mahmoud Gad
Organization
Sohag University Hospital - Faculty of Medicine

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator and Resident in Internal medicine department, Sohag University Hospitals

Study Record Dates

First Submitted

November 15, 2024

First Posted

November 19, 2024

Study Start

February 1, 2025

Primary Completion

December 1, 2025

Study Completion

January 1, 2026

Last Updated

March 2, 2026

Results First Posted

March 2, 2026

Record last verified: 2026-02

Locations