DIETary Intake, Death and Hospitalization in Adult With End-stage Kidney Disease Treated With HemoDialysis (DIET-HD) Study

NCT03125265 | Completed

• 1 other identifier: DIET-HD study
• Study Type: observational
• Target: 9,757
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diet Habit; End Stage Renal Disease

Keywords

nutrition; hemodialysis; mortality; omega 3

Outcome Measures

Primary Outcomes (1)

• Cardiovascular mortality

  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

  12 months since baseline dietary evaluation

Secondary Outcomes (3)

• All-cause mortality

  12 months since baseline dietary evaluation

• Infection-related mortality

  12 months since baseline dietary evaluation

• All-cause and cardiovascular related hospitalisation

  12 months since baseline dietary evaluation

Interventions

dietary intake of omega-3 and omega-6 polyunsaturated fatty acids OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

dialysis clinics administered by a single dialysis provider

You may qualify if:

• End-stage kidney disease
• Long-term haemodialysis for at least the previous 90 days
• years or older
• Treating team agrees to the patient's involvement in the study
• Participant willing to provide written and informed consent.-

You may not qualify if:

• 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

Sponsors & Collaborators

• Giovanni Strippoli: lead
• University of Sydney: collaborator

MeSH Terms

Conditions

Feeding Behavior; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Giovanni FM Strippoli, MD, PhD

  University of Bari

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: April 24, 2017
• Study Start: January 5, 2014
• Primary Completion: January 31, 2016
• Study Completion: January 31, 2016
• Last Updated: April 24, 2017

Record last verified: 2017-04