Studying the Effect of Dialysate Temperature on Toxin Removal and Hypotension

NCT02064153 | Completed DMC

• 1 other identifier: DSRB 2013/1950
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Dialysis Amyloidosis; Hypotension

Keywords

Dialysate temperature; Spent dialysate; Toxin removal; Intra-dialytic hypotension; Inter-compartmental resistance

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Monitoring of physiological changes

  1 month

Study Arms (2)

Cool dialysate

ACTIVE COMPARATOR

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

Procedure: Cool dialysate

Warm dialysate

ACTIVE COMPARATOR

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

Procedure: Warm dialysate

Interventions

Cool dialysate 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.

Also known as: Cool dialysate at 35.5ºC, Warm dialysate at 37ºC

Cool dialysate

Warm dialysate PROCEDURE

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

Also known as: Warm dialysate at 37ºC

Warm dialysate

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National University of Singapore: collaborator

Study Sites (1)

SLF Dialysis Center, National University Hospital

Singapore, SGN, 298135, Singapore

Location

Related Publications (2)

• 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. doi: 10.1681/ASN.V95877.

  PMID: 9596086 BACKGROUND

• Maheshwari V, Lau T, Samavedham L, Rangaiah GP. Effect of cool vs. warm dialysate on toxin removal: rationale and study design. BMC Nephrol. 2015 Feb 27;16:25. doi: 10.1186/s12882-015-0017-5.

  PMID: 25885180 DERIVED

Related Links

• Effects of controlled blood cooling on hemodynamic stability and urea kinetics during high-efficiency hemodialysis
• A regional blood flow model for β2-microglobulin kinetics and for simulating intra-dialytic exercise effect

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Titus Lau, MD

  National University Hospital, Singapore

  STUDY DIRECTOR

• Vaibhav Maheshwari, PhD

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2014
• First Posted: February 17, 2014
• Study Start: July 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: January 1, 2015
• Last Updated: April 3, 2015

Record last verified: 2015-04

Locations

SG (1)