Cooler Dialysis and Liver Perfusion and Function

NCT02997774 | Completed

• 1 other identifier: 108616
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Haemodialysis Complication

Outcome Measures

Primary Outcomes (1)

• Change in regional liver perfusion in mls/min/100g from baseline to peak stress during dialysis (3 hours into the dialysis session) with standard versus cooler dialysate temperature.

  2 years

Secondary Outcomes (8)

• Change in global liver perfusion in mls/min/100g pre, during and post-dialysis with cooler dialysate

  2 years

• ICG clearance rate pre, during and post-dialysis with cooler vs standard dialysate

  2 years

• Contribution of portal venous flow to hepatic perfusion (PV fraction) pre, during and post-dialysis with cooler vs standard dialysate

  2 years

• Endotoxin levels with cooler vs standard dialysate

  2 years

• Troponin T levels with cooler vs standard dialysate

  2 years

Study Arms (2)

Standard Dialysis

ACTIVE COMPARATOR

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

Other: Standard Dialysis

Cooler Dialysis

EXPERIMENTAL

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

Other: Cooler dialysis

Interventions

Cooler dialysis OTHER

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

Cooler Dialysis

Standard Dialysis OTHER

Having dialysis at a standard temperature (36.5 degrees Celsius)

Standard Dialysis

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Chris McIntyre: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, Canada

Location

Study Officials

• Chris W McIntyre, PhD

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Neither subjects nor the investigator at the study visits will be blinded; however, analysis of imaging data will be performed with the operator blinded to allocation.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine, UWO

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: December 20, 2016
• Study Start: February 8, 2017
• Primary Completion: May 4, 2018
• Study Completion: May 4, 2018
• Last Updated: August 17, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)