Does Oral Pentoxifylline Administration Improve Hemoglobin in Hemodialysis Patients?
Paraules clau
Resum
Descripció
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.
Dates
| Darrera verificació: | 10/31/2018 |
| Primer enviat: | 11/01/2018 |
| Inscripció estimada enviada: | 11/02/2018 |
| Publicat per primera vegada: | 11/05/2018 |
| Última actualització enviada: | 11/05/2018 |
| Publicació de l'última actualització: | 11/07/2018 |
| Data d'inici de l'estudi real: | 10/31/2017 |
| Data estimada de finalització primària: | 05/02/2018 |
| Data estimada de finalització de l’estudi: | 05/03/2018 |
Condició o malaltia
Intervenció / tractament
Drug: treatment group
Fase
Grups de braços
| Braç | Intervenció / tractament |
|---|---|
| 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. |
Criteris d'elegibilitat
| Edats elegibles per estudiar | 18 Years Per a 18 Years |
| Sexes elegibles per estudiar | All |
| Accepta voluntaris saludables | Sí |
| Criteris | 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. |
Resultat
Mesures de resultats primaris
1. hemoglobin difference [after 6 months from the start]
Mesures de resultats secundaris
1. difference in inflammatory markers [after 6 months from the start]
