Coffee in Hemodialysis and Headache

NCT04057313 | Completed

• 1 other identifier: CoffeeHD2019
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

Coffee is the most consumed drink worldwide, sometimes needed to boost energy and other times to entertain social connectivity. Caffeine is mostly present unbound in the plasma, only 10 to 30% of caffeine binds to plasma proteins. It is distributed freely into the intracellular space, and it has a small distribution volume. Therefore, caffeine can pass through the dialysis membrane during a standard hemodialysis session. In hemodialysis patients, headache occurs in 40 to 75% of patients. Some authors have suggested that one of the reasons of headache during hemodialysis is caffeine withdrawal. This trial aims to find whether coffee intake during hemodialysis reduces the headache episodes. It is a randomized double blind multicenter trial where 160 patients will be randomized to 2 groups: group 1 of 80 patients will be given a cup of coffee each dialysis session for 4 weeks and group 2 will receive decaffeinated coffee each dialysis session for 4 weeks.

Conditions

Hemodialysis Complication

Keywords

Coffee; Headache; Intra-dialytic hypotension

Outcome Measures

Primary Outcomes (1)

• number of headache episodes

  number of headache episodes during or immediately after dialysis over 12

  4 weeks

Secondary Outcomes (4)

• number of intra-dialytic hypotensive episodes

  4 weeks

• number of sleeping hours per night

  4 weeks

• energy after dialysis

  4 weeks

• irritability

  4 weeks

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Group 1 will receive 80 cc of coffee in the dialysis session

Dietary Supplement: Coffee

Group 2

PLACEBO COMPARATOR

Group 2 will receive 80 cc of decaffeinated coffee in the dialysis session

Dietary Supplement: Coffee

Interventions

Coffee DIETARY_SUPPLEMENT

Coffee used will be the boiled unfiltered Arabica coffee

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients \> 18 years old on chronic hemodialysis

You may not qualify if:

• patients with a history of chronic or paroxysmal atrial fibrillation
• patients on chronic systematic pain killers
• patients with a problem of swallowing food or drinks
• patients who are coffee allergic or intolerant.

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Saint-Georges Hospital

Ajaltoun, Kesrouan, Lebanon

Location

Related Publications (1)

• Aoun MH, Hilal N, Beaini C, Sleilaty G, Hajal J, Boueri C, Chelala D. Effects of Caffeinated and Decaffeinated Coffee on Hemodialysis-Related Headache (CoffeeHD): A Randomized Multicenter Clinical Trial. J Ren Nutr. 2021 Nov;31(6):648-660. doi: 10.1053/j.jrn.2021.01.025. Epub 2021 Mar 12.

  PMID: 33715955 DERIVED

MeSH Terms

Conditions

Headache

Interventions

Coffee

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Mabel Aoun, MD

  Saint-Joseph University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding will be ensured by an outsider who will hold the coffee cups to nurses with the name of patients on the cups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: A randomized multicenter trial: hemodialysis patients in three dialysis units will be randomized to two groups, group 1 will take coffee for 4 weeks, group 2 will take decaffeinated coffee for 4 weeks

Study Record Dates

• First Submitted: August 11, 2019
• First Posted: August 15, 2019
• Study Start: September 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)