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Studying the Effect of Dialysate Temperature on Toxin Removal and Hypotension

NCT02064153 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2015-04-03

No results posted yet for this study

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.

Conditions

Interventions

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.

PROCEDURE

Warm dialysate

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

Sponsors & Collaborators

Principal Investigators

  • Titus Lau, MD · National University Hospital, Singapore

  • Vaibhav Maheshwari, PhD · National University of Singapore

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-03-31
Completion
2015-01-31

Countries

  • Singapore

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02064153 on ClinicalTrials.gov