Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Observational Study
. 2015 Dec 9;5(12):e009328.
doi: 10.1136/bmjopen-2015-009328.

COGNITIVE-HD study: protocol of an observational study of neurocognitive functioning and association with clinical outcomes in adults with end-stage kidney disease treated with haemodialysis

Suetonia C Palmer  1 , Marinella Ruospo  2 , Maria Rosaria Barulli  3 , Annalisa Iurillo  3 , Valeria Saglimbene  4 , Patrizia Natale  4 , Letizia Gargano  4 , Angelo M Murgo  4 , Clement Loy  5 , Anita van Zwieten  6 , Germaine Wong  6 , Rosanna Tortelli  3 , Jonathan C Craig  6 , David W Johnson  7 , Marcello Tonelli  8 , Jörgen Hegbrant  4 , Charlotta Wollheim  4 , Giancarlo Logroscino  9 , G F M Strippoli  10 ; COGNITIVE-HD Study Investigators
Collaborators, Affiliations
Observational Study

COGNITIVE-HD study: protocol of an observational study of neurocognitive functioning and association with clinical outcomes in adults with end-stage kidney disease treated with haemodialysis

Suetonia C Palmer et al. BMJ Open. .

Abstract

Introduction: The prevalence of cognitive impairment may be increased in adults with end-stage kidney disease compared with the general population. However, the specific patterns of cognitive impairment and association of cognitive dysfunction with activities of daily living and clinical outcomes (including withdrawal from treatment) among haemodialysis patients remain incompletely understood. The COGNITIVE impairment in adults with end-stage kidney disease treated with HemoDialysis (COGNITIVE-HD) study aims to characterise the age-adjusted and education-adjusted patterns of cognitive impairment (using comprehensive testing for executive function, perceptual-motor function, language, learning and memory, and complex attention) in patients on haemodialysis and association with clinical outcomes.

Methods and analysis: A prospective, longitudinal, cohort study of 750 adults with end-stage kidney disease treated with long-term haemodialysis has been recruited within haemodialysis centres in Italy (July 2013 to April 2014). Testing for neurocognitive function was carried out by a trained psychologist at baseline to assess cognitive functioning. The primary study factor is cognitive impairment and secondary study factors will be specific domains of cognitive function. The primary outcome will be total mortality. Secondary outcomes will be cause-specific mortality, major cardiovascular events, fatal and non-fatal myocardial infarction and stroke, institutionalisation, and withdrawal from treatment at 12 months.

Ethics and dissemination: This protocol was approved before study conduct by the following responsible ethics committees: Catania (approval reference 186/BE; 26/09/2013), Agrigento (protocol numbers 61-62; 28/6/2013), USL Roma C (CE 39217; 24/6/2013), USL Roma F (protocol number 0041708; 23/7/2013), USL Latina (protocol number 20090/A001/2011; 12/7/2013), Trapani (protocol number 3413; 16/7/2013) and Brindisi (protocol number 40259; 6/6/2013). All participants have provided written and informed consent and can withdraw from the study at any time. The findings of the study will be disseminated through peer-reviewed journals and national and international conference presentations and to the participants through communication within the dialysis network in which this study is conducted.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Study design.
See this image and copyright information in PMC

References

    1. American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 5th edn Washington DC, 2013.
    1. Graham JE, Rockwood K, Beattie BL et al. . Prevalence and severity of cognitive impairment with and without dementia in an elderly population. Lancet 1997;349:1793–6. 10.1016/S0140-6736(97)01007-6 - DOI - PubMed
    1. Brookmeyer R, Gray S, Kawas C. Projections of Alzheimer's disease in the United States and the public health impact of delaying disease onset. Am J Public Health 1998;88:1337–42. 10.2105/AJPH.88.9.1337 - DOI - PMC - PubMed
    1. Murray CJ, Vos T, Lozano R et al. . Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012;380:2197–223. 10.1016/S0140-6736(12)61689-4 - DOI - PubMed
    1. DeCarli C. Mild cognitive impairment: prevalence, prognosis, aetiology, and treatment. Lancet Neurol 2003;2:15–21. 10.1016/S1474-4422(03)00262-X - DOI - PubMed

Publication types

MeSH terms