Does Oral Pentoxifylline Administration Improve Hemoglobin in Hemodialysis Patients?
Kľúčové slová
Abstrakt
Popis
Fifty out of 57 hemodialysis anemic patients were finally included. They were assigned to two groups of equal numbers. Oral Pentoxifylline 400mg once daily was added to the treatment group which was compared to the control group over a six months period regarding hemoglobin, hematocrit, serum albumin and CRP.
Inclusion criteria: (Patients with ESRD on HD who have hemoglobin <11 g/dl, taking Erythropoietin alfa 4000 -12000 I.U/wk and having a urea reduction ratio >65%.). There were 57 patients who met the inclusion criteria out of 158 patients.
Exclusion criteria: Iron deficiency anemia with transferrin saturation <30%, intact PTH>300pg/ml, vitamin B12 or folate deficiency (evidenced by macrocytosis), history of intolerance to pentoxifylline or other xanthine derivatives, recent retinal or cerebral hemorrhage or active peptic ulcer disease, pregnancy or breastfeeding, presence of systemic hematological disease or known hemoglobinopathy, major surgery, infection, acute myocardial infarction, or malignancy within the last three months and patients who refused to participate in the study.
Termíny
Naposledy overené: | 10/31/2018 |
Prvý príspevok: | 11/01/2018 |
Odhadovaná registrácia bola odoslaná: | 11/02/2018 |
Prvý príspevok: | 11/05/2018 |
Posledná aktualizácia bola odoslaná: | 11/05/2018 |
Posledná aktualizácia bola zverejnená: | 11/07/2018 |
Aktuálny dátum začatia štúdie: | 10/31/2017 |
Odhadovaný dátum dokončenia primárneho okruhu: | 05/02/2018 |
Odhadovaný dátum dokončenia štúdie: | 05/03/2018 |
Stav alebo choroba
Intervencia / liečba
Drug: treatment group
Fáza
Skupiny zbraní
Arm | Intervencia / liečba |
---|---|
Experimental: treatment group Group I: 29 patients (25 completed the study) that received the study agent (400mg of oral pentoxifylline daily for 6 months.), besides the appropriate weight-based dose of ESA (60-150I.U/kg/wk). | Drug: treatment group a known drug of xanthine derivatives used in intermittent claudication |
No Intervention: control group Group II: 28 patients (25 completed the study) who did not receive pentoxifylline but they received the appropriate dose of ESA. They were used as a control group and compared to group1 concerning the primary and the secondary outcomes. |
Kritériá oprávnenosti
Vek vhodný na štúdium | 18 Years To 18 Years |
Pohlavia vhodné na štúdium | All |
Prijíma zdravých dobrovoľníkov | Áno |
Kritériá | Inclusion Criteria: - (Patients with ESRD on HD who have hemoglobin <11 g/dl, taking Erythropoietin alfa 4000 -12000 I.U/wk and having a urea reduction ratio >65%.). There were 57 patients who met the inclusion criteria out of 158 patients Exclusion Criteria: - Iron deficiency anemia with transferrin saturation <30%, intact PTH>300pg/ml, vitamin B12 or folate deficiency (evidenced by macrocytosis), history of intolerance to pentoxifylline or other xanthine derivatives, recent retinal or cerebral hemorrhage or active peptic ulcer disease, pregnancy or breastfeeding, presence of systemic hematological disease or known hemoglobinopathy, major surgery, infection, acute myocardial infarction, or malignancy within the last three months and patients who refused to participate in the study. |
Výsledok
Primárne výstupné opatrenia
1. hemoglobin difference [after 6 months from the start]
Opatrenia sekundárnych výsledkov
1. difference in inflammatory markers [after 6 months from the start]