NCT Number: NCT03125265
DIETary Intake, Death and Hospitalization in Adult With End-stage Kidney Disease Treated With HemoDialysis (DIET-HD) Study
The DIETary intake, death and hospitalisation in adults with end-stage kidney disease treated with HaemoDialysis (DIET-HD) study is a multinational prospective cohort study designed to evaluate the association between nutrition and dietary patterns and health outcomes in prevalent adult haemodialysis patients in Europe and South America.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- End-stage kidney disease
- Long-term haemodialysis for at least the previous 90 days
- 18 years or older
- Treating team agrees to the patient's involvement in the study
- Participant willing to provide written and informed consent.-
Exclusion criteria
- significant neurocognitive disability or medical comorbidity that would preclude them from understanding the dietary questionnaire even if assisted
- a life expectancy less than 6 months according to their treating physician
- planned kidney transplantation within 6 months of baseline
Treatment and study plan
Primary outcomes
-
Cardiovascular mortality
Time frame: 12 months since baseline dietary evaluation
Defined as sudden death or death attributed to acute myocardial infarction, pericarditis, atherosclerotic heart disease, cardiomyopathy, cardiac arrhythmia, cardiac arrest, valvular heart disease, pulmonary edema, or congestive cardiac failure
Secondary outcomes
-
All-cause mortality
Time frame: 12 months since baseline dietary evaluation
-
Infection-related mortality
Time frame: 12 months since baseline dietary evaluation
-
All-cause and cardiovascular related hospitalisation
Time frame: 12 months since baseline dietary evaluation
Sponsors and collaborators
Lead sponsor
Giovanni Strippoli
Other
Collaborators
- University of Sydney
Registry information
Important dates
- Study start
- 2014
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Apr 24, 2017
- Registry last updated
- Apr 24, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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