pH, Hypoxia and Haemodialysis

NCT04501159 | Unknown

• 1 other identifier: 281803
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

End-stage renal disease typically requires haemodialysis to help replace kidney function. However, changes in oxygen uptake during haemodialysis have been linked to increased all-cause mortality. This complication of haemodialysis is linked to decreasing fluid volume, compromising blood flow to tissue and leukostasis within pulmonary tissue. However, an alternative cause of reduced oxygen availability (hypoxia) during haemodialysis is acute alkalosis. Alkalosis during haemodialysis can cause hypoxia via dysregulated ventilation and impaired ability for tissue to extract oxygen. Despite strong rationale for these mechanisms, few studies have fully explored causes of hypoxia during haemodialysis. Greater understanding may help to mitigate the risk associated with this vital treatment option. The study will comprise of end-stage renal disease patients who regularly undergo haemodialysis. Three blood samples will be attained before, during and after haemodialysis to assess arterial blood gases. In a small subset of patients, white blood cell (WBC) count and cardiac output will be assessed via a non-invasive cardiac output monitor during treatment. Regression analysis will be performed to help identify predictors of hypoxia during haemodialysis. Patient burden is negligible, with blood samples attained from the dialyser as part of routine treatment. In the patients who agree for cardiac output assessment, the patient will be required to have four small noninvasive sensor pads placed on the chest. Patients will be assessed over 3 consecutive treatments during a single week.

Conditions

End Stage Renal Disease on Dialysis

Keywords

ESRD: End-stage renal disease; ABG: Arterial blood gases; NICOM: Non-invasive cardiac output monitour; HD: Haemodialysis; WBC: white blood cell

Outcome Measures

Primary Outcomes (2)

• To assess change from baseline to end of haemodialysis in pH.

  Blood samples will be collected in heparinized syringes via HD catheter from end-stage renal disease patients before commencing HD and on HD completion. Arterial blood pH will be determined by ABG analyser immediately after blood sample collection. Patients will be assessed for ABG during a typical week (3 days) of HD treatment.

  Change in pH pre to post HD over 3 separate HD treatments in a single week.

• To assess change from baseline to end of haemodialysis in PaO2.

  Blood samples will be collected in heparinized syringes via HD catheter from end-stage renal disease patients before commencing HD and on HD completion. Arterial oxygen tension (PaO2) will be determined by ABG analyser immediately after blood sample collection. Patients will be assessed for ABG during a typical week (3 days) of HD treatment.

  Change in PaO2 pre to post HD over 3 separate HD treatments in a single week.

Secondary Outcomes (2)

• To assess changes in pH status over a standard three session HD treatment week assessed via ABG.

  Before and after HD over 3 separate treatments in a single week.

• To assess if pH is a better predictor of hypoxia during HD than cardiac output.

  Assessed before, during (15 mins HD) and after HD on first treatment of the week.

Study Arms (1)

End-stage renal disease (ESRD)

Patients with end-stage renal disease undergoing regular haemodialysis 3 times weekly.The investigation will measure cardiac output (CO), oxygen saturation (SaO2), arterial blood gases (ABG) and white blood cell (WBC) count during HD to assess changes in haemodynamics, pH, leukostasis and hypoxia. Patients undergoing regular HD will be recruited with arterial blood samples for gas analysis drawn over three consecutive HD treatments. Arterial samples will be taken at the start, 15 minutes and end of HD treatment for ABG and WBC analysis. Dialysis membrane, ultrafiltration volume, serum and dialysate bicarbonate levels will also be recorded. Regression analysis will be performed with pH, ABG and SaO2. A subset of patients will be used to assess an if cardiac output, WBC or pH better predicts PaO2 during HD.

Other: blood sample pre, during and post HD; Device: Non invasive cardiac output assessment

Interventions

blood sample pre, during and post HD OTHER

Assessment of ABG pre, during and post HD

End-stage renal disease (ESRD)

Non invasive cardiac output assessment DEVICE

Four ECG style electrodes are placed on the thorax which indirectly measures cardiac output.

Also known as: NICOM

End-stage renal disease (ESRD)

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

End-stage renal disease patients will be recruited from the University Hospitals Coventry \& Warwickshire hemodialysis unit identified by the research team and renal medical professionals.

You may qualify if:

• On haemodialysis for at least 3 months.
• Haemodialysis 3 times per week.
• Age 18 years or older.

You may not qualify if:

• Central venous catheter.
• Planned kidney transplant during the duration of study.

Sponsors & Collaborators

• Coventry University: lead
• University Hospitals Coventry and Warwickshire NHS Trust: collaborator

Study Sites (2)

UHCW

Coventry, Warwickshire, CV1 3LN, United Kingdom

RECRUITING

University Hospital Coventry and Warwickshire

Coventry, West Midlands, CV3, United Kingdom

RECRUITING

Related Publications (10)

• McGuire S, Horton EJ, Renshaw D, Jimenez A, Krishnan N, McGregor G. Hemodynamic Instability during Dialysis: The Potential Role of Intradialytic Exercise. Biomed Res Int. 2018 Feb 27;2018:8276912. doi: 10.1155/2018/8276912. eCollection 2018.

  PMID: 29682559 BACKGROUND

• Yap JC, Wang YT, Poh SC. Effect of oxygen on breathing irregularities during haemodialysis in patients with chronic uraemia. Eur Respir J. 1998 Aug;12(2):420-5. doi: 10.1183/09031936.98.12020420.

  PMID: 9727795 BACKGROUND

• Assa S, Hummel YM, Voors AA, Kuipers J, Westerhuis R, Groen H, Bakker SJ, Muller Kobold AC, van Oeveren W, Struck J, de Jong PE, Franssen CF. Hemodialysis-induced regional left ventricular systolic dysfunction and inflammation: a cross-sectional study. Am J Kidney Dis. 2014 Aug;64(2):265-73. doi: 10.1053/j.ajkd.2013.11.010. Epub 2013 Dec 21.

  PMID: 24364893 BACKGROUND

• Buchanan C, Mohammed A, Cox E, Kohler K, Canaud B, Taal MW, Selby NM, Francis S, McIntyre CW. Intradialytic Cardiac Magnetic Resonance Imaging to Assess Cardiovascular Responses in a Short-Term Trial of Hemodiafiltration and Hemodialysis. J Am Soc Nephrol. 2017 Apr;28(4):1269-1277. doi: 10.1681/ASN.2016060686. Epub 2016 Nov 10.

  PMID: 28122851 BACKGROUND

• Dasselaar JJ, Slart RH, Knip M, Pruim J, Tio RA, McIntyre CW, de Jong PE, Franssen CF. Haemodialysis is associated with a pronounced fall in myocardial perfusion. Nephrol Dial Transplant. 2009 Feb;24(2):604-10. doi: 10.1093/ndt/gfn501. Epub 2008 Sep 4.

  PMID: 18775808 BACKGROUND

• Kossari N, Hufnagel G, Squara P. Bioreactance: a new tool for cardiac output and thoracic fluid content monitoring during hemodialysis. Hemodial Int. 2009 Oct;13(4):512-7. doi: 10.1111/j.1542-4758.2009.00386.x. Epub 2009 Sep 16.

  PMID: 19758300 BACKGROUND

• Misra M. Pro: Higher serum bicarbonate in dialysis patients is protective. Nephrol Dial Transplant. 2016 Aug;31(8):1220-4. doi: 10.1093/ndt/gfw259. Epub 2016 Jul 13.

  PMID: 27411723 BACKGROUND

• Tentori F, Karaboyas A, Robinson BM, Morgenstern H, Zhang J, Sen A, Ikizler TA, Rayner H, Fissell RB, Vanholder R, Tomo T, Port FK. Association of dialysate bicarbonate concentration with mortality in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis. 2013 Oct;62(4):738-46. doi: 10.1053/j.ajkd.2013.03.035. Epub 2013 May 24.

  PMID: 23707043 BACKGROUND

• Saravanan P, Davidson NC. Risk assessment for sudden cardiac death in dialysis patients. Circ Arrhythm Electrophysiol. 2010 Oct;3(5):553-9. doi: 10.1161/CIRCEP.110.937888. No abstract available.

  PMID: 20959609 BACKGROUND

• Gabutti L, Ferrari N, Giudici G, Mombelli G, Marone C. Unexpected haemodynamic instability associated with standard bicarbonate haemodialysis. Nephrol Dial Transplant. 2003 Nov;18(11):2369-76. doi: 10.1093/ndt/gfg383.

  PMID: 14551368 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

• Scott McGuire, PhD

  Coventry University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott McGuire, PhD

CONTACT

07980113721; ad5055@uni.coventry.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-Doctoral Researcher

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 6, 2020
• Study Start: May 1, 2021
• Primary Completion: August 21, 2021
• Study Completion: December 29, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)