Dialysis AmyloidosisNCT02064153
Studying the Effect of Dialysate Temperature on Toxin Removal and Hypotension
A study testing Cool dialysate and Warm dialysate in people with Dialysis Amyloidosis and Hypotension, run by National University Hospital, Singapore at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Dialysis Amyloidosis, Hypotension
- What is being tested?
- Cool dialysate and Warm dialysate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2013to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site
SLF Dialysis Center, National University Hospital
Singapore, SGN, 298135
About this study
Official title: 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.
Read the 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.
- Conditions
- Dialysis Amyloidosis, Hypotension
- Being tested
- Cool dialysate, Warm dialysate
- Keywords
- Dialysate temperature, Spent dialysate, Toxin removal, Intra-dialytic hypotension, Inter-compartmental resistance
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cool dialysateProcedure or surgery
Also called Cool dialysate at 35.5ºC, Warm dialysate at 37ºC
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 dialysateProcedure or surgery
Also called Warm dialysate at 37ºC
All recruited patients will undergo two study sessions - Cool dialysis (35.5ºC) and Warm dialysis (37ºC)
| Study group | Role | What they receive |
|---|---|---|
| Cool dialysate | Active comparator | Recruited study subject undergoes cool dialysate (35.5ºC) session. Receives: Procedure: Cool dialysate |
| Warm dialysate | Active comparator | Recruited study subject undergoes warm dialysate (37ºC) session. Receives: Procedure: Warm dialysate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (1)
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startJul 2013
- Primary completionMar 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dialysis AmyloidosisStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Sponsor
- Investigators
- Titus Lau, MD, Study director, National University Hospital, SingaporeVaibhav Maheshwari, PhD, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064153
- Sponsor's protocol ID
- DSRB 2013/1950
- Status last verified
- Apr 2015
- First submitted
- 13 Feb 2014
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 9596086Maheshwari 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.
PubMed 25885180
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential of Manipulating the Dialysate Temperature for Prevention of Intra-dialytic Hypotensive Episodes in Maintenance Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT02064153
- Acronym / sponsor ID
- DSRB 2013/1950
- Conditions
- Dialysis Amyloidosis, Hypotension
- Keywords
- Dialysate temperature, Spent dialysate, Toxin removal, Intra-dialytic hypotension, Inter-compartmental resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National University of Singapore
- Study start
- Jul 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cool dialysate | Active comparator | Procedure: Cool dialysateRecruited study subject undergoes cool dialysate (35.5ºC) session. |
| Warm dialysate | Active comparator | Procedure: Warm dialysateRecruited study subject undergoes warm dialysate (37ºC) session. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cool dialysateAlso: Cool dialysate at 35.5ºC, Warm dialysate at 37ºCEach 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 or surgery | Cool dialysate |
| Warm dialysateAlso: Warm dialysate at 37ºCAll recruited patients will undergo two study sessions - Cool dialysis (35.5ºC) and Warm dialysis (37ºC) | Procedure or surgery | Warm dialysate |
Primary outcome
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 secondary outcome
Monitoring of physiological changes
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
- Background: PubMed 9596086Kaufman 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.
- Derived from this study: PubMed 25885180Maheshwari 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.
- Effects of controlled blood cooling on hemodynamic stability and urea kinetics during high-efficiency hemodialysisLink provided by the sponsor.
- A regional blood flow model for β2-microglobulin kinetics and for simulating intra-dialytic exercise effectLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Titus Lau, MD study director
National University Hospital, Singapore
Vaibhav Maheshwari, PhD principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cool dialysate and Warm dialysate in people with Dialysis Amyloidosis and Hypotension, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantify toxin removal based on spent dialysate (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02064153, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2015.