Studying the Effect of Dialysate Temperature on Toxin Removal and Hypotension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dialysis Amyloidosis Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Cool dialysate

Recruited study subject undergoes cool dialysate (35.5ºC) session.

Group Type ACTIVE_COMPARATOR

Cool dialysate

Intervention Type PROCEDURE

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

Recruited study subject undergoes warm dialysate (37ºC) session.

Group Type ACTIVE_COMPARATOR

Warm dialysate

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Warm dialysate

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

Intervention Type PROCEDURE

Other Intervention Names

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Cool dialysate at 35.5ºC Warm dialysate at 37ºC Warm dialysate at 37ºC

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No