P1869COFFEE INTAKE AND HEADACHE IN HAEMODIALYSIS (COFFEEHD TRIAL): A RANDOMIZED DOUBLE BLIND MULTICENTER CLINICAL TRIAL

Abstract

Abstract Background and Aims Coffee with its major component caffeine can enhance alertness and decrease tiredness and headache. Headache was reported in 40 to 75 % of hemodialysis patients. Caffeine circulates unbound in the blood and passes the dialysis membrane. Some authors suggested that headache can result from caffeine withdrawal. This study aims to compare the incidence of headache and hypotension between patients taking or not coffee during dialysis. Method This is a randomized double-blind multicenter trial. Patients of three hemodialysis units were included. Patients with atrial fibrillation were excluded. 156 patients were randomized to two groups, group A was given 80 cc of coffee and group B 80 cc of decaffeinated coffee in the middle of the session for 12 consecutive sessions. Ultrafiltration rate was fixed to a maximum of 13 ml/kg/h. The primary outcome was the incidence of headache and the secondary incidence of hypotension. This clinical trial received the approval of the ethics committee of Saint-Joseph University (HDF-1463) and was registered on ClinicalTrials.Gov (NCT04057313). Results A total of 139 patients completed the trial (6.4% vs 15.4 % of withdrawal in groups A and B respectively). Baseline characteristics are summarized in Table 1. The number of sessions with headache was not significantly different between group A and B (34% vs 37% respectively, p=0.522), nor the number of sessions with hypotension (27% vs 26% respectively, p= 0.539). In a subgroup analysis, headache was higher in group B (p=0.06) in two categories of patients: those with the highest potassium dialysate (K=2) and the non-hypertensive patients. Conclusion Headache occurred in 34 to 37% of dialysis sessions. There was no difference in headache or hypotensive episodes between patients in the coffee versus decaffeinated group.