Open label multi-center randomized parallel two-group comparison test of the effects of hemoglobin levels on cardiovascular complications, prognosis, and quality of life in chronic hemodialysis patients

Authors
Category Primary study
JournalUMIN Clinical Trials Registry
Year 2006
INTERVENTION: Adjust doses of iron erythropoietin to maintain hemoglobin level between 9.0 to 10.5 g/dl Adjust doses of iron and erythropoietin to maintain hemoglobin level between 11.0 to 12.0 g/dl CONDITION: Patients on hemodialysis therapy due to end‐stage renal failure PRIMARY OUTCOME: 1) Patient death by any cause including accidental death and every kind of complications.; 2) Newly diagnosed ischemic heart diseases: acute myocardial infarction, coronary heart disease diagnosed by coronary arteriography, percutaneous coronary intervention, coronary artery bypass grafting; 3) Shunt failure: any procedures for reconstruction of A‐V fistula due to decreased blood flow.; 4) Newly diagnosed cereberovascular diseases: cerebral hemorrhage/infarction, subarachnoid hemorrhage; 5) Newly diagnosed peripheral vessel disorders: intermittent claudication with definitive peripheral vascular disorders, newly developed ulcer or gangrene of extremities, delayed wound healing. SECONDARY OUTCOME: 1) Changes in sf36 scores; 2) Changes in urine volume; 3) Changes in left ventricular mass index measured by echocardiography; 4) Changes in pulse wave velocity; 5) Hospitalization due to any diseases including hospitalization for clinical evaluation of the newly developed diseases INCLUSION CRITERIA: Male and female patients; age between 21 years old and 80 years old. Written informed consent must be obtained. Patients should be on hemodialysis for longer than 3 months and in stable medical condition.
Epistemonikos ID: 61d3bcdd476f4b8bb71ca9c21738b0f937975245
First added on: Aug 21, 2024