Studying the Effect of Dialysate Temperature on Toxin Removal and Hypotension

April 1, 2015 updated by: National University Hospital, Singapore

Potential of Manipulating the Dialysate Temperature for Prevention of Intra-dialytic Hypotensive Episodes in Maintenance Hemodialysis Patients

Hemodialysis (HD) is widely used treatment for end stage renal diseases (ESRD) patients. The chief aims of HD are solute and fluid removal. Decades of practice have improved HD care, but more can be done to improve morbidity and mortality. Enhancing toxin removal is an important consideration for improved patient outcomes. Also, decreasing the incidence of intra-dialytic hypotensive (IDH) episodes (dominant in Singapore patient cohort) can significantly reduce associated morbidities and mortality. A simple maneuver for clinicians is the dialysate temperature. Literature suggests that a lower dialysate temperature (35ºC) results in reduced hypotensive episodes by vasoconstriction. Conversely, higher dialysate temperature resulting in higher blood temperature decreases the peripheral resistance, leading to increased toxin removal, but may cause IDH episodes partly due to vasodilation. Optimal manipulation of the dialysate temperature is therefore primary handles to obtain the improved patient outcomes. In this study, the effect of dialysate temperature (cool vs. warm dialysate) on toxin removal will be studied. In both the interventions, outcome measure will be patient hemodynamic response and amount of toxins removed. The spent dialysate will be collected to study the quantum of toxin removed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cool dialysate, by vasoconstriction, is simple maneuver to control and/or prevent incidence of intra-dialytic hypotension (IDH). During dialysis fluid is continuously removed. IDH occurs when plasma refilling rate is smaller than the set ultra-filtration rate. When plasma refiling rate is small, continuous fluid removal bring patient to the threshold state where patient does not have sufficient fluid in central compartment. This leads to the cascade of events, viz., low blood pressure, muscle cramps, dizziness, being first few manifestation. To minimize the occurrence of such events, clinicians often prescribe cool dialysate resulting in vasoconstriction, which ensures sufficient fluid volume in central body compartment so that continuous fluid loss does not impact patient hemodynamics severely.

It is important to note that vasoconstriction may also inhibit the toxin movement from remote peripheral compartments to central blood compartment, and thus less toxin will be removed. On the other hand warm dialysate leading to vasodilation will mobilize the toxins in remote peripheral compartments and increase the toxin influx in central blood compartment. Few researchers have investigate the effect of dialysate temperature on urea removal, but urea is not a true marker of toxin milieu. In this pilot clinical research, we will compare the effect of dialysate temperature on removal of both small and large sized uremic toxins. Our objective is not to study the effect of dialysate temperature on incidence of IDH, so we will recruit subjects who are stable on dialysis and have no prior history of IDH episodes.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
    • SGN
      • Singapore, SGN, Singapore, 298135
        • SLF Dialysis Center, National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adult patients male or female (Age > 21 years, < 70 years)
  2. Minimum dialysis vintage of 3 months
  3. Stable on hemodialysis
  4. Blood access capable of delivering the blood flow rate greater than 250 mL/min

Exclusion Criteria:

  1. History of recurring or persistent hypotension in past 1 month
  2. Pregnant woman
  3. Severely hypertensive patients (Systolic blood pressure > 180 mmHg and/or Diastolic blood pressure > 115 mmHg)
  4. Severely hypotensive patients (Systolic blood pressure < 100 mm Hg and/or Diastolic blood pressure < 60 mmHg)
  5. Paradoxically hypertensive patients whose BP increases by more than 20% of baseline during dialysis (during past 1 month)
  6. History of recent myocardial infarction or unstable angina (within past 6 months)
  7. Significant valvular disease, i.e. severe aortic stenosis and moderate-severe mitral regurgitation
  8. Patients with end stage organ disease e.g. chronic obstructive pulmonary disease (COPD), recent or debilitating cerebrovascular attack (CVA)
  9. Patient with recent stroke (within past 6 months)
  10. History of known arrhythmia
  11. Participation in another clinical intervention trial
  12. Unable to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cool dialysate
Recruited study subject undergoes cool dialysate (35.5ºC) session.
Procedure: Cool dialysate
Each recruited patient undergoes a cool dialysate session ( 35.5ºC) and a warm dialysate session (37ºC). The sessions are minimum a week apart to remove the carryover effect.
Other Names:
  • Cool dialysate at 35.5ºC
  • Warm dialysate at 37ºC
Active Comparator: Warm dialysate
Recruited study subject undergoes warm dialysate (37ºC) session.
Procedure: Warm dialysate
All recruited patients will undergo two study sessions - Cool dialysis (35.5ºC) and Warm dialysis (37ºC)
Other Names:
  • Warm dialysate at 37ºC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantify toxin removal based on spent dialysate
Time Frame: 1 month
Collect the whole dialysate and measure the toxin concentration. This will provide the amount of toxin removed during study session. Compare the removed toxin mass for cool vs warm dialysate session.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monitoring of physiological changes
Time Frame: 1 month
Cool dialysate may lead to stability of patient, but may also result in chilling sensation during dialysis. On the other hand, warm dialysate may cause intra-dialytic hypotensive episode. In both sessions, patient physiological changes will be monitored.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Collaborators

National University of Singapore

Investigators

  • Study Director: Titus Lau, MD, National University Hospital, Singapore
  • Principal Investigator: Vaibhav Maheshwari, PhD, National University of Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

February 13, 2014

First Submitted That Met QC Criteria

February 13, 2014

First Posted (Estimate)

February 17, 2014

Study Record Updates

Last Update Posted (Estimate)

April 3, 2015

Last Update Submitted That Met QC Criteria

April 1, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSRB 2013/1950

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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