Cooler Dialysis and Liver Perfusion and Function

NCT ID: NCT02997774

Last Updated: 2018-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-08
• Study Completion Date: 2018-05-04

Brief Summary

Having hemodialysis affects the blood supply to various organs in the body including the heart and the brain. With time, these effects build up and can affect the way these organs function. The investigators have previously shown that the liver (a key organ which works to help clean the blood, make proteins and turn all your food into energy) is also affected. One of the ways to help protect organs from injury due to dialysis has been cooling during dialysis. The investigators want to examine whether cooling during dialysis protects the blood supply to the liver. CT imaging will be used to measure this blood supply during hemodialysis with standard and cooler settings.

Detailed Description

Hemodialysis exerts significant hemodynamic effects with widespread consequences on vulnerable vascular beds. Cardiac injury, including myocardial stunning and subclinical myocardial ischemia, appears to be common and associated with significantly increased mortality. The liver has been shown to have preserved blood flow due to its dual blood supply. Even so, the liver excretory function is decreased and endotoxin levels in the blood increase during hemodialysis. Extracorporeal cooling during dialysis has been associated with protective effects on the brain and heart of dialysis patients. The effects of cooler dialysis on liver perfusion, function and endotoxemia during hemodialysis is unknown.

The investigators therefore propose to use CT perfusion imaging to examine the effect of cooling during hemodialysis on liver perfusion, relating this effect to endotoxin translocation and myocardial dysfunction. Additionally, they intend to investigate the potential effects on hepatic function in this context, examining the relationship between liver perfusion and endotoxemia, the metabolism of uremic toxins and clinical symptoms of uremia.

This is a prospective randomized cross-over study involving a single center recruiting patients from the prevalent dialysis population of London Health Sciences Centre (LHSC) Renal Program. Once recruited, patients will undergo two study hemodialysis sessions - one will use standard dialysate temperature of 36.5 degrees Celsius (HD36.5) and one will use cooler dialysate temperature at 35 degrees Celsius (HD35). The order of these two sessions will be randomly allocated. Before, during and after each session, participants will undergo cardiac and hepatic assessment. This will include CT scans, 2D echocardiography and indocyanine green (ICG) clearance measurements. In addition, participants will answer a number of questionnaires about uremic symptoms and blood tests will also be done.

The investigators' aim is to characterize and compare liver function and perfusion before during and after hemodialysis, with standard and cooler dialysate temperature.

Conditions

Haemodialysis Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Standard Dialysis

Patient will undergo dialysis at 36.5 degrees Celsius to assess if this affects the liver function and perfusion

Group Type: ACTIVE_COMPARATOR

Standard Dialysis

Intervention Type: OTHER

Having dialysis at a standard temperature (36.5 degrees Celsius)

Cooler Dialysis

Patient will undergo dialysis at 35 degrees Celsius to assess if this affects the liver function and perfusion

Group Type: EXPERIMENTAL

Cooler dialysis

Intervention Type: OTHER

Having dialysis at a slightly cooler temperature (35 vs 36.5 degrees Celsius)

Interventions

Cooler dialysis

Having dialysis at a slightly cooler temperature (35 vs 36.5 degrees Celsius)

Intervention Type: OTHER

Standard Dialysis

Having dialysis at a standard temperature (36.5 degrees Celsius)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Be able to provide informed consent
• Age greater than 18 years
• Hemodialysis for at least 3 months
• No significant residual renal function (<250mls urine/day)

Exclusion Criteria

• Chronic liver disease of any stage
• Chronic intestinal disease excluding Irritable Bowel Syndrome (IBS)
• Previous liver transplant or liver resection
• Previous Transjugular Portosystemic Shunt (TIPSS) insertion
• Active infection or malignancy
• Pregnant, breastfeeding or intending pregnancy
• Unable to give consent or understand written information
• Diabetic and experiencing hypoglycemia during dialysis within the last 2 months
• Known allergy/intolerance to contrast agent or iodides

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chris McIntyre

OTHER

Sponsor Role: lead

Responsible Party

Chris McIntyre

Professor of Medicine, UWO

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Chris W McIntyre, PhD

Role: PRINCIPAL_INVESTIGATOR

Western University, Canada

Locations

London Health Sciences Centre

London, Ontario, Canada

Countries

Canada

Other Identifiers

108616

Identifier Type: -

Identifier Source: org_study_id