Dyspnea Assessment in Hemodialysis Patients

NCT03773991 | Completed

• 1 other identifier: 110256
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Shortness of breath is very common among patients on dialysis for kidney failure; however, its causes are often not understood. This study will explore the lungs and the heart of these patients to determine the causes of shortness of breath. The amount of salt in the body tissues, which tends to accumulate in dialysis patients and can also cause shortness of breath, will also be measured. Machines that exploit magnetic resonance, ultrasound and x-rays to take images of the body interior will be employed; in addition, breathing tests, questionnaires and blood tests will also be used. 20 patients on dialysis will be recruited and have two visits: one at the beginning of the study and one year later to observe any changes in the lungs, heart and salt accumulation over time.

Conditions

Dyspnea; Uremic; End Stage Renal Disease; Chronic Lung Disease; Chronic Heart Disease; Hemodialysis-Induced Symptom; Sodium Excess

Keywords

Dyspnea; Hemodialysis; End Stage Renal Disease

Outcome Measures

Primary Outcomes (8)

• Baseline Modified Medical Research Council scale score.

  Baseline dyspnea measured by Modified Medical Research Council scale. 0-4 from lowest (no dyspnea) to highest (most severe dyspnea).

  Baseline

• Baseline University of California, San Diego Shortness of Breath Questionnaire score.

  Baseline dyspnea measured by University of California, San Diego Shortness of Breath Questionnaire. 0-120 from lowest (no dyspnea) to highest (most severe dyspnea).

  Baseline

• Baseline pulmonary artery diameter.

  Baseline pulmonary artery diameter (in millimeters) by chest Computed Tomography.

  Baseline

• Baseline lung total blood vessel volume.

  Baseline lung total blood vessel volume in ml by chest Computed Tomography.

  Baseline

• Baseline lung total airway count.

  Baseline lung total airway count by chest Computed Tomography.

  Baseline

• Baseline lung low attenuation area.

  Baseline lung low attenuation area by chest Computed Tomography.

  Baseline

• Baseline lung water content.

  Baseline lung water content in arbitrary units measured by proton Magnetic Resonance Imaging.

  Baseline

• Baseline soft tissue sodium content.

  Baseline soft tissue sodium content in mmol/L measured by sodium Magnetic Resonance Imaging.

  Baseline

Secondary Outcomes (34)

• One year changes in Modified Medical Research Council scale score.

  Baseline and one year

• Correlation between baseline modified Medical Research Council scale score and one year morbidity.

  Baseline and one year

• Correlation between baseline modified Medical Research Council scale score and one year mortality.

  Baseline and one year

• Correlation between modified Medical Research Council scale score and soft tissue sodium content.

  Baseline and one year

• Correlation between modified Medical Research Council scale score and pulmonary artery diameter.

  Baseline and one year

Study Arms (1)

Maintenance Hemodialysis Patients

Patients on chronic hemodialysis therapy due to end-stage renal disease. * Proton Lung MRI * Sodium MRI of the leg * Chest CT * Transthoracic Echocardiography * Fractional Exhaled Nitric Oxide * Six-Minute Walk Test * Pulmonary Function Tests * Blood sampling * Self-administered dyspnea questionnaires

Diagnostic Test: Lung MRI; Diagnostic Test: Sodium MRI; Diagnostic Test: Chest CT; Diagnostic Test: Echocardiography; Diagnostic Test: Fractional Exhaled Nitric Oxide; Diagnostic Test: Pulmonary Function Tests; Diagnostic Test: Blood Sampling; Diagnostic Test: Six-Minute Walk Test; Diagnostic Test: Dyspnea Questionnaires

Interventions

Lung MRI DIAGNOSTIC_TEST

Proton Lung Magnetic Resonance Imaging

Maintenance Hemodialysis Patients

Sodium MRI DIAGNOSTIC_TEST

Sodium Soft Tissue Magnetic Resonance Imaging

Maintenance Hemodialysis Patients

Chest CT DIAGNOSTIC_TEST

High-resolution Quantitative Chest CT

Maintenance Hemodialysis Patients

Echocardiography DIAGNOSTIC_TEST

Transthoracic 2D Speckle-Tracking Echocardiography

Maintenance Hemodialysis Patients

Fractional Exhaled Nitric Oxide DIAGNOSTIC_TEST

Fractional Exhaled Nitric Oxide testing

Maintenance Hemodialysis Patients

Pulmonary Function Tests DIAGNOSTIC_TEST

Spirometry and Plethysmography

Maintenance Hemodialysis Patients

Blood Sampling DIAGNOSTIC_TEST

Blood testing for: standard-of-care, inflammatory biomarkers, uremic toxins

Maintenance Hemodialysis Patients

Six-Minute Walk Test DIAGNOSTIC_TEST

Six-Minute Walk Test

Maintenance Hemodialysis Patients

Dyspnea Questionnaires DIAGNOSTIC_TEST

Modified Medical Research Council; University of California, San Diego Shortness of Breath Questionnaire; Borg Scale

Maintenance Hemodialysis Patients

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

The patients for this trial will be recruited from incident and prevalent hemodialysis patients receiving care for their kidney disease from the Dialysis Service at London Health Sciences Centre, London Ontario. Up to 20 eligible patients will be recruited.

You may qualify if:

• Age equal to or greater than 18 years.
• Dialysis vintage equal to or greater than 3 months.

You may not qualify if:

• Smoking history of more than 10 packs/year.
• Active tobacco and/or cannabis smoking.
• Diagnosed chronic pulmonary disease.
• Severe heart failure (NYHA class IV)
• Active infection (including tuberculosis) or malignancy.
• Pregnancy.
• Inability to give consent or understand written information.
• Peripheral oxygen saturation (by pulse oxymetry) dropping below 80% when performing a 12-seconds breathhold.
• Inability to perform spirometry or plethysmography maneuvers.
• Inability to tolerate MRI due to patient size and/or known history of claustrophobia.
• Subject has an implanted mechanically, electrically or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants.).

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, Canada

Location

Related Publications (15)

• Murtagh FE, Addington-Hall JM, Edmonds PM, Donohoe P, Carey I, Jenkins K, Higginson IJ. Symptoms in advanced renal disease: a cross-sectional survey of symptom prevalence in stage 5 chronic kidney disease managed without dialysis. J Palliat Med. 2007 Dec;10(6):1266-76. doi: 10.1089/jpm.2007.0017.

  PMID: 18095805 BACKGROUND

• Fairshter RD, Vaziri ND, Mirahmadi MK. Lung pathology in chronic hemodialysis patients. Int J Artif Organs. 1982 Mar;5(2):97-100.

  PMID: 7095887 BACKGROUND

• Zoccali C, Torino C, Tripepi R, Tripepi G, D'Arrigo G, Postorino M, Gargani L, Sicari R, Picano E, Mallamaci F; Lung US in CKD Working Group. Pulmonary congestion predicts cardiac events and mortality in ESRD. J Am Soc Nephrol. 2013 Mar;24(4):639-46. doi: 10.1681/ASN.2012100990. Epub 2013 Feb 28.

  PMID: 23449536 BACKGROUND

• Nascimento MM, Qureshi AR, Stenvinkel P, Pecoits-Filho R, Heimburger O, Cederholm T, Lindholm B, Barany P. Malnutrition and inflammation are associated with impaired pulmonary function in patients with chronic kidney disease. Nephrol Dial Transplant. 2004 Jul;19(7):1823-8. doi: 10.1093/ndt/gfh190. Epub 2004 May 18.

  PMID: 15150347 BACKGROUND

• Wallin CJ, Jacobson SH, Leksell LG. Subclinical pulmonary oedema and intermittent haemodialysis. Nephrol Dial Transplant. 1996 Nov;11(11):2269-75. doi: 10.1093/oxfordjournals.ndt.a027147.

  PMID: 8941589 BACKGROUND

• Bolignano D, Rastelli S, Agarwal R, Fliser D, Massy Z, Ortiz A, Wiecek A, Martinez-Castelao A, Covic A, Goldsmith D, Suleymanlar G, Lindholm B, Parati G, Sicari R, Gargani L, Mallamaci F, London G, Zoccali C. Pulmonary hypertension in CKD. Am J Kidney Dis. 2013 Apr;61(4):612-22. doi: 10.1053/j.ajkd.2012.07.029. Epub 2012 Nov 17.

  PMID: 23164943 BACKGROUND

• Barak M, Nakhoul F, Katz Y. Pathophysiology and clinical implications of microbubbles during hemodialysis. Semin Dial. 2008 May-Jun;21(3):232-8. doi: 10.1111/j.1525-139X.2008.00424.x. Epub 2008 Mar 18.

  PMID: 18363602 BACKGROUND

• Plesner LL, Warming PE, Nielsen TL, Dalsgaard M, Schou M, Host U, Rydahl C, Brandi L, Kober L, Vestbo J, Iversen K. Chronic obstructive pulmonary disease in patients with end-stage kidney disease on hemodialysis. Hemodial Int. 2016 Jan;20(1):68-77. doi: 10.1111/hdi.12342. Epub 2015 Aug 5.

  PMID: 26245152 BACKGROUND

• Pabst S, Hammerstingl C, Hundt F, Gerhardt T, Grohe C, Nickenig G, Woitas R, Skowasch D. Pulmonary hypertension in patients with chronic kidney disease on dialysis and without dialysis: results of the PEPPER-study. PLoS One. 2012;7(4):e35310. doi: 10.1371/journal.pone.0035310. Epub 2012 Apr 18.

  PMID: 22530005 BACKGROUND

• Herrero JA, Alvarez-Sala JL, Coronel F, Moratilla C, Gamez C, Sanchez-Alarcos JM, Barrientos A. Pulmonary diffusing capacity in chronic dialysis patients. Respir Med. 2002 Jul;96(7):487-92. doi: 10.1053/rmed.2002.1346.

  PMID: 12194631 BACKGROUND

• Kovacevic P, Stanetic M, Rajkovaca Z, Meyer FJ, Vukoja M. Changes in spirometry over time in uremic patients receiving long-term hemodialysis therapy. Pneumologia. 2011 Jan-Mar;60(1):36-9.

  PMID: 21545062 BACKGROUND

• McIntyre CW, Odudu A. Hemodialysis-associated cardiomyopathy: a newly defined disease entity. Semin Dial. 2014 Mar;27(2):87-97. doi: 10.1111/sdi.12197.

  PMID: 24738144 BACKGROUND

• Belem LC, Zanetti G, Souza AS Jr, Hochhegger B, Guimaraes MD, Nobre LF, Rodrigues RS, Marchiori E. Metastatic pulmonary calcification: state-of-the-art review focused on imaging findings. Respir Med. 2014 May;108(5):668-76. doi: 10.1016/j.rmed.2014.01.012. Epub 2014 Feb 6.

  PMID: 24529738 BACKGROUND

• Incalzi RA, Corsonello A, Pedone C, Battaglia S, Paglino G, Bellia V; Extrapulmonary Consequences of COPD in the Elderly Study Investigators. Chronic renal failure: a neglected comorbidity of COPD. Chest. 2010 Apr;137(4):831-7. doi: 10.1378/chest.09-1710. Epub 2009 Nov 10.

  PMID: 19903974 BACKGROUND

• Romoff MS, Keusch G, Campese VM, Wang MS, Friedler RM, Weidmann P, Massry SG. Effect of sodium intake on plasma catecholamines in normal subjects. J Clin Endocrinol Metab. 1979 Jan;48(1):26-31. doi: 10.1210/jcem-48-1-26. No abstract available.

  PMID: 422701 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum.

MeSH Terms

Conditions

Dyspnea; Kidney Failure, Chronic; Hypernatremia

Interventions

Echocardiography; Fractional Exhaled Nitric Oxide Testing; Respiratory Function Tests; Blood Specimen Collection; Walk Test

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; 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; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Breath Tests; Diagnostic Techniques, Respiratory System; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques; Exercise Test

Study Officials

• Christopher W McIntyre, MD PhD

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Medical Biophysics and Paediatrics, University of Western Ontario. Director of The Lilibeth Caberto Kidney Clinical Research Unit, London Health Sciences Centre.

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 12, 2018
• Study Start: March 29, 2019
• Primary Completion: February 25, 2020
• Study Completion: February 25, 2020
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)