Studying the Effect of Dialysate Temperature on Toxin Removal and Hypotension

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02064153
• Other study ID #: DSRB 2013/1950
• Status: Completed
• Phase: N/A
• First received: February 13, 2014
• Last updated: April 1, 2015
• Start date: July 2013
• Est. completion date: January 2015

Study information

• Verified date: April 2015
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Amyloidosis
• Dialysis Amyloidosis
• Hypotension

Intervention

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.
• Warm dialysate
All recruited patients will undergo two study sessions - Cool dialysis (35.5ºC) and Warm dialysis (37ºC)

Locations

Country	Name	City	State
Singapore	SLF Dialysis Center, National University Hospital	Singapore	SGN

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	National University, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (1)

Kaufman AM, Morris AT, Lavarias VA, Wang Y, Leung JF, Glabman MB, Yusuf SA, Levoci AL, Polaschegg HD, Levin NW. Effects of controlled blood cooling on hemodynamic stability and urea kinetics during high-efficiency hemodialysis. J Am Soc Nephrol. 1998 May;9(5):877-83. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantify toxin removal based on spent dialysate	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	No
Secondary	Monitoring of physiological changes	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	Yes

External Links

•   A regional blood flow model for ß2-microglobulin kinetics and for simulating intra-dialytic exercise effect
•   Effects of controlled blood cooling on hemodynamic stability and urea kinetics during high-efficiency hemodialysis