Trial Outcomes & Findings for Different Ultrafiltration Rates and Intradialytic Hypotension. (NCT NCT06695923)
NCT ID: NCT06695923
Last Updated: 2026-03-02
Results Overview
Finding the optimal threshold of ultrafiltration rates to prevent intradialytic hypotension through observing the risk factors associated with the occurrence of HDH
Recruitment status
COMPLETED
Target enrollment
50 participants
Primary outcome timeframe
6 month
Results posted on
2026-03-02
Participant Flow
Participant milestones
| Measure |
50 Patients
This study was conducted on 50 patients with CKD on regular hemodialysis receiving three sessions weekly, aged more than 18 years, with the exclusion of
* Patients aged \< 18 years old.
* Patients on recent hemodialysis \< 3 months.
* Pregnant women.
* Patients with malignancy, severe infections, or sepsis.
* Patients with major bleeding.
* Patients who cannot undergo 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.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
50 Patients
n=50 Participants
This study was conducted on 50 patients with CKD on regular hemodialysis receiving three sessions weekly, aged more than 18 years, with the exclusion of
* Patients aged \< 18 years old.
* Patients on recent hemodialysis \< 3 months.
* Pregnant women.
* Patients with malignancy, severe infections, or sepsis.
* Patients with major bleeding.
* Patients who cannot undergo 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.
|
|---|---|
|
Age, Continuous
|
48.59 years
STANDARD_DEVIATION 14.61 • n=50 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=50 Participants
|
|
Region of Enrollment
Egypt
|
50 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: 6 monthPopulation: All enrolled patients who completed follow-up over 6 months were included in the analysis
Finding the optimal threshold of ultrafiltration rates to prevent intradialytic hypotension through observing the risk factors associated with the occurrence of HDH
Outcome measures
| Measure |
50 Patients
n=3600 HD sessions
This study was conducted on 50 patients with CKD on regular hemodialysis receiving three sessions weekly, aged more than 18 years, with the exclusion of
* Patients aged \< 18 years old.
* Patients on recent hemodialysis \< 3 months.
* Pregnant women.
* Patients with malignancy, severe infections, or sepsis.
* Patients with major bleeding.
* Patients who cannot undergo 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.
|
|---|---|
|
Prevent Intradialytic Hypotension
sessions with intradialytic hypotension
|
1089 HD sessions
|
|
Prevent Intradialytic Hypotension
sessions without intradialytic hypotension
|
2511 HD sessions
|
PRIMARY outcome
Timeframe: 6 monthsAnalysis of the prevalence of chronic illness among the study participants, as well as the number of antihypertensive drugs used.
Outcome measures
| Measure |
50 Patients
n=50 Participants
This study was conducted on 50 patients with CKD on regular hemodialysis receiving three sessions weekly, aged more than 18 years, with the exclusion of
* Patients aged \< 18 years old.
* Patients on recent hemodialysis \< 3 months.
* Pregnant women.
* Patients with malignancy, severe infections, or sepsis.
* Patients with major bleeding.
* Patients who cannot undergo 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.
|
|---|---|
|
Clinical History Among the Study Patients.
DM
|
8 Participants
|
|
Clinical History Among the Study Patients.
Hypertension
|
16 Participants
|
|
Clinical History Among the Study Patients.
Cardiovascular diseases
|
13 Participants
|
|
Clinical History Among the Study Patients.
No Number of antihypertensive drugs
|
34 Participants
|
|
Clinical History Among the Study Patients.
One Number of antihypertensive drugs
|
12 Participants
|
|
Clinical History Among the Study Patients.
Two Number of antihypertensive drugs
|
4 Participants
|
Adverse Events
50 Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Marwa Mahmoud Gad
Sohag University Hospital - Faculty of Medicine
Phone: +2001274690410
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place