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Coffee in Hemodialysis and Headache (CoffeeHD)

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ClinicalTrials.gov Identifier: NCT04057313
Recruitment Status : Recruiting
First Posted : August 15, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Mabel Aoun, Saint-Joseph University

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.

Condition or disease Intervention/treatment Phase
Hemodialysis Complication Dietary Supplement: Coffee Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Blinding will be ensured by an outsider who will hold the coffee cups to nurses with the name of patients on the cups
Primary Purpose: Treatment
Official Title: Coffee Intake in HemoDialysis and Headache (CoffeeHD): a Randomized Double Blind Multicenter Clinical Trial
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Headache

Arm Intervention/treatment
Active Comparator: Group 1
Group 1 will receive 80 cc of coffee in the dialysis session
Dietary Supplement: Coffee
Coffee used will be the boiled unfiltered Arabica coffee

Placebo Comparator: Group 2
Group 2 will receive 80 cc of decaffeinated coffee in the dialysis session
Dietary Supplement: Coffee
Coffee used will be the boiled unfiltered Arabica coffee




Primary Outcome Measures :
  1. number of headache episodes [ Time Frame: 4 weeks ]
    number of headache episodes during or immediately after dialysis over 12


Secondary Outcome Measures :
  1. number of intra-dialytic hypotensive episodes [ Time Frame: 4 weeks ]
    number of intra-dialytic hypotensive episodes during trial over 12

  2. number of sleeping hours per night [ Time Frame: 4 weeks ]
    number of sleeping hours per night during the trial (average)

  3. energy after dialysis [ Time Frame: 4 weeks ]
    energy after dialysis on a scale from 1 to 10 (1 is no energy and 10 is full energy)

  4. irritability [ Time Frame: 4 weeks ]
    irritability during the trial (question: are you easily irritated? yes/no)



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All adult patients > 18 years old on chronic hemodialysis

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04057313


Contacts
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Contact: Mabel Aoun, MD +9613351588 mabel.aoun@usj.edu.lb
Contact: Dania Chelala, MD +9613566229 daniachelala@hotmail.com

Locations
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Lebanon
Saint-Georges Hospital Recruiting
Ajaltoun, Kesrouan, Lebanon
Contact: Mabel Aoun, MD    009619234201 ext 1103    aounmabel@yahoo.fr   
Contact: Roula Haber    009619234201 ext 1111      
Principal Investigator: Mabel Aoun, MD         
Sponsors and Collaborators
Saint-Joseph University
Investigators
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Principal Investigator: Mabel Aoun, MD Saint-Joseph University

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Responsible Party: Mabel Aoun, Dr, Saint-Joseph University
ClinicalTrials.gov Identifier: NCT04057313     History of Changes
Other Study ID Numbers: CoffeeHD2019
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mabel Aoun, Saint-Joseph University:
Coffee
Headache
Intra-dialytic hypotension
Additional relevant MeSH terms:
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Headache
Pain
Neurologic Manifestations
Signs and Symptoms