Effects of Caffeinated and Decaffeinated Coffee on Hemodialysis-Related Headache (CoffeeHD): A Randomized Multicenter Clinical Trial.

Objectives Historically, headache was reported in up to 76% of hemodialysis patients. Some authors suggested that headache resulted from caffeine withdrawal. This study aims to compare the incidence of headache and hypotension between patients drinking regular or decaffeinated coffee during dialysis. Methods One-hundred fifty-six patients were enrolled in this randomized, double-blind, placebo-controlled, multicenter study. Patients with atrial fibrillation were excluded. Group A was given 80 mL of regular coffee and group B 80 mL of decaffeinated coffee (placebo) in the middle of the session for 12 consecutive sessions. Ultrafiltration rate was fixed to a maximum of 13 mL/kg/hour. The primary outcome was the incidence of headache during dialysis. Results A total of 139 patients completed the trial (6.4% vs. 15.4% of withdrawal in Groups A and B, respectively). The number of sessions with headache was not significantly different between Group A and B (33.3% vs. 37.1% respectively, P = .522), nor the number of sessions with hypotension (27% vs. 26% respectively, P = .539). In a subgroup analysis, headache tended to be more frequent in Group B (P = .06) in 2 categories of patients: those with the highest potassium dialysate (K = 2) and the non-hypertensive patients. Conclusions Headache occurred in 35% of patients during their chronic hemodialysis sessions. Caffeine intake did not prevent headache occurrence in these patients.