ACTRN12624001137583Active, not recruitingPhase 4
Effect Of Testosterone Replacement On Anemia And Quality Of Life Amongst Patients On Maintenance Hemodialysis
Dr Qurat Ul Ain Azam - Pak Emirates Military Hospital0 sites24 target enrollmentStarted: September 20, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 24
- Primary Endpoint
- any change in hemoglobin levels[Haemoglobin levels by running blood samples in automated hematology cbc analysers Baseline and at every months upto 6 months following the intervention]
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (—)
- Sex
- Male
Inclusion Criteria
- •Patients diagnosed with end-stage renal disease (ESRD) requiring maintenance hemodialysis.
- •Patients with documented anemia, defined as haemoglobin levels < 10 g/dL
- •Patients with stable medical conditions, defined as absence of acute illness or major surgical procedures within the past three months.
- •Patients who have been on a stable hemodialysis regimen for at least three months prior to enrollment.
Exclusion Criteria
- •Patients with known hypersensitivity or contraindications to testosterone replacement therapy (TRT).
- •Patients with active malignancy, including prostate cancer.
- •Patients with uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg).
- •Patients with severe liver disease (e.g., cirrhosis) or severe hepatic dysfunction (e.g., Child-Pugh class B or C).
- •Patients with severe cardiac disease (e.g., congestive heart failure, recent myocardial infarction) or unstable cardiovascular conditions.
- •Patients with a history of thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism).
- •Patients with significant psychiatric illness or cognitive impairment that may affect their ability to participate in the study or provide informed consent.
Outcomes
Primary Outcomes
any change in hemoglobin levels[Haemoglobin levels by running blood samples in automated hematology cbc analysers Baseline and at every months upto 6 months following the intervention]
Secondary Outcomes
- Quality of life[Questionnaire base quality of life assessment utilizing WHOQOL-BREF Baseline and at every month till 6 months following intervention]
Investigators
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