End-Stage Kidney DiseasePhase 4NSD5NCT02590081
Effect of Sodium Rinsing Fluid on Blood Pressure and Interdialytic Weight Change in Hemodialysis Patients
A Phase 4 study testing Dextrose 5% and normal saline in people with End-Stage Kidney Disease and Hemodialysis, run by Penang Hospital, Malaysia at 15 sites in Malaysia.
Trial summary
This is a prospective, randomized, double-blind, parallel group trial to assess the efficacy and safety of intravenous dextrose 5% solution compare with normal saline (standard care) in wash back procedure during haemodialysis in patients with end stage renal failure (ESRF) with respect to systolic blood pressure… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- End-Stage Kidney Disease, Hemodialysis
- What is being tested?
- Dextrose 5% and normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 434 participants
- Where
- 15 sitesMalaysia
- Study dates
- Oct 2015to Oct 2016
- Phase
- Phase 4
- 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 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory, clinically stable maintenance HD patients on a thrice weekly HD regime.
- Have regular hemodialysisforat least 6 months or more.
- Willing and able to provide written, signed informed consent after the nature of the study has been explained.
- Willing and able to comply with all study procedures.
- Age ≥18 years; Age < 75 years old
Who cannot join
- Diabetes mellitus, Malignancy, Pregnancy
- Inability or unwillingness to provide written consent.
- Inability or unwillingness to comply with the requirements of the protocol as determined by the investigator.
- Simultaneous participation in another clinical study except observational trials
- Any psychological condition which could interfere with the patient's ability to comply with the study protocol
- Inability to perform a blood pressure measurement on the upper limb
Show all 14Show fewer
- Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD or plans to relocate to another center during the study period.
- Life expectancy < 6 months
- Recent acute myocardial infarction, congestive cardiac failure, stroke, angina or ICU admission within last 6 months,
- Planned to migrate/move out of the city
- Alcohol abuse/ drug abuse within last 6 months
- Missed > 2 hemodialysis sessions over 1 month
- Requiring non- cuff catheter for hemodialysis
- Admitted for major infection within the last one month
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Malaysia15 sites
Hospital Sultanah Bahiyah, Alor Setar
Alor Star, Kedah, 05460
Chen Hua Ching, MRCP, +60-04-7496898, nchching@yahoo.com
Hospital Balik Pulau
Balik Pulau, Pulau Pinang, 11000
Loke Meng Ong
Hospital Bukit Mertajam
Bukit Mertajam, Pulau Pinang, 14000
Anita Bhajan
UKM Medical Centre
Cheras, Kuala Lumpur, 56000
Abdul Halim Abdul Gafor, M.Med, +60-03-91456074, halimgafor@gmail.com
Penang Hospital
George Town, Pulau Pinang, 10990
Ong Loke Meng, FRCS, 00 604 2225333 ext. 5767, onglokemeng@gmail.com
Hospital Kepala Batas
Kepala Batas, Pulau Pinang, 13200
Anita Bhajan
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, 50586
Ghazali Ahmad Kutty, M.Med, +60-03-26155380, ghazaliahmad@moh.gov.my
UM Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100
Soo Kun Lim, +60-0379492497, sookun_73@yahoo.com
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, 25100
Mohd Ramli Seman, M.Med, +60-09-5572222, mohdramliseman9@gmail.com
Miri Hospital
Miri, Sarawak, 98000
Keng Hee Koh, MRCP(UK), +60-85-420033, kohkenghee@yahoo.com
Seberang Jaya Hospital
Seberang Jaya, Pulau Pinang, 13700
Anita Bhajan, +60-04-3827496, abmanocha1518@gmail.com
Selayang Hospital
Selayang Baru Utara, Selangor, 68100
Hin Seng Wong, FRCP, +60-03-61367788, hinseng@gmail.com
Hospital Serdang
Serdang, Selangor, 43400
Bak Leong Goh, FRCP, +60-03-89475555, bak.leong@gmail.com
Hospital Tuanku Jaafar
Seremban, Negeri Sembilan, 70300
Lily Mushahar, M.Med, +60 6-7684000, lilymushahar@hotmail.com
Hospital Sungai Bakap
Sungai Bakap, Pulau Pinang, 14200
Anita Bhajan
About this study
Official title: A Prospective Randomized, Double-Blind Parallel Group Trial To Assess The Efficacy And Safety Of Intravenous Dextrose 5% Solution Compare With Normal Saline (Standard Care) In Rinsing During Haemodialysis In Subjects With End Stage Renal Failure (ESRF) With Respect To Systolic Blood Pressure Control Over 3 Months Period.
This is a prospective, randomized, double-blind, parallel group trial to assess the efficacy and safety of intravenous dextrose 5% solution compare with normal saline (standard care) in wash back procedure during haemodialysis in patients with end stage renal failure (ESRF) with respect to systolic blood pressure control over 3 months period.
The primary objective is to establish efficacy of 5% dextrose solution compared with normal saline (0.9% sodium chloride solution) with respect to systolic blood pressure control in subjects with end stage renal failure (ESRF) on regular hemodialysis. Secondary objectives include monitoring the change in body weight, thirst level and body fluid volume.
- Conditions
- End-Stage Kidney Disease, Hemodialysis
- Being tested
- Dextrose 5%, normal saline
- Keywords
- Normal saline, Destrose 5%, Blood pressure, Interdialytic weight gain, thirst level, End Stage Renal Failure
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextrose 5%Drug
normal salineDrug
| Study group | Role | What they receive |
|---|---|---|
| Normal saline | Active comparator | Normal saline will be used for wash back procedure at the end of hemodiaysis. Receives: Drug: normal saline |
| dextrose 5% | Experimental | Dextrose 5% will be used for wash back procedure at the end of hemodiaysis. Receives: Drug: Dextrose 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
systolic blood pressure control
post intervention systolic blood pressure reduction compared to baseline
Measured: Time from week 0 until week 12
Secondary outcomes (4)
Interdialytic weight gain
reduced Interdialytic weight gain in experimental group
Measured: Time from week 0 until week 12
thirst level
Dialysis thirst inventory questionnaire to be administer by patient at baseline (week 0) and end of trial (week 12)
Measured: Time from week 0 and week 12
intradialytic event
Any incident occuring during hemodialysis treatment which needed medical intervention. The event are chills and rigor, chest pain, giddiness, cramps, vomiting, blood loss and hypotension.
Measured: Time from week 0 until week 12
adverse events
All observed or spontaneously reported adverse events occur during the trial period.
Measured: Time from week 0 until week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2016 (estimated)
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 End-Stage Kidney DiseaseStudies of the same condition, open and under way.
- 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 434 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penang Hospital, Malaysia
- Sponsor type
- Other government
- Collaborators
- Ministry of Health, Malaysia
- Responsible party
- Principal investigator, Dr.Ong Loke Meng, Penang Hospital, Malaysia
- Investigators
- Loke Meng Ong, FRCP, Principal investigator, Penang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590081
- Sponsor's protocol ID
- NMRR-14-950-20443
- Acronym
- NSD5
- Status last verified
- Oct 2015
- First submitted
- 27 Oct 2015
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Agarwal R. Epidemiology of interdialytic ambulatory hypertension and the role of volume excess. Am J Nephrol. 2011;34(4):381-90. doi: 10.1159/000331067. Epub 2011 Sep 2.
PubMed 21893975Brennan JM, Ronan A, Goonewardena S, Blair JE, Hammes M, Shah D, Vasaiwala S, Kirkpatrick JN, Spencer KT. Handcarried ultrasound measurement of the inferior vena cava for assessment of intravascular volume status in the outpatient hemodialysis clinic. Clin J Am Soc Nephrol. 2006 Jul;1(4):749-53. doi: 10.2215/CJN.00310106. Epub 2006 May 24.
PubMed 17699282
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized, Double-Blind Parallel Group Trial To Assess The Efficacy And Safety Of Intravenous Dextrose 5% Solution Compare With Normal Saline (Standard Care) In Rinsing During Haemodialysis In Subjects With End Stage Renal Failure (ESRF) With Respect To Systolic Blood Pressure Control Over 3 Months Period.
- ClinicalTrials.gov ID
- NCT02590081
- Acronym / sponsor ID
- NSD5 / NMRR-14-950-20443
- Conditions
- End-Stage Kidney Disease, Hemodialysis
- Keywords
- Normal saline, Destrose 5%, Blood pressure, Interdialytic weight gain, thirst level, End Stage Renal Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 434 participants (estimated)
- Lead sponsor
- Penang Hospital, MalaysiaOther government
- Collaborators
- Ministry of Health, Malaysia
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (estimated)
- First posted
- 28 Oct 2015 (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.
This is a prospective, randomized, double-blind, parallel group trial to assess the efficacy and safety of intravenous dextrose 5% solution compare with normal saline (standard care) in wash back procedure during haemodialysis in patients with end stage renal failure (ESRF) with respect to systolic blood pressure control over 3 months period.
The primary objective is to establish efficacy of 5% dextrose solution compared with normal saline (0.9% sodium chloride solution) with respect to systolic blood pressure control in subjects with end stage renal failure (ESRF) on regular hemodialysis. Secondary objectives include monitoring the change in body weight, thirst level and body fluid volume.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal saline | Active comparator | Drug: normal salineNormal saline will be used for wash back procedure at the end of hemodiaysis. |
| dextrose 5% | Experimental | Drug: Dextrose 5%Dextrose 5% will be used for wash back procedure at the end of hemodiaysis. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ambulatory, clinically stable maintenance HD patients on a thrice weekly HD regime.
- Have regular hemodialysisforat least 6 months or more.
- Willing and able to provide written, signed informed consent after the nature of the study has been explained.
- Willing and able to comply with all study procedures.
- Age ≥18 years; Age < 75 years old
Key exclusion criteria (14 listed)
- Diabetes mellitus, Malignancy, Pregnancy
- Inability or unwillingness to provide written consent.
- Inability or unwillingness to comply with the requirements of the protocol as determined by the investigator.
- Simultaneous participation in another clinical study except observational trials
- Any psychological condition which could interfere with the patient's ability to comply with the study protocol
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 |
|---|---|---|
| Dextrose 5% | Drug | dextrose 5% |
| normal saline | Drug | Normal saline |
Primary outcome
systolic blood pressure control
Time frame: Time from week 0 until week 12
post intervention systolic blood pressure reduction compared to baseline
4 secondary outcomes
Interdialytic weight gain
Time frame: Time from week 0 until week 12
thirst level
Time frame: Time from week 0 and week 12
intradialytic event
Time frame: Time from week 0 until week 12
adverse events
Time frame: Time from week 0 until week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
- Background: PubMed 21893975Agarwal R. Epidemiology of interdialytic ambulatory hypertension and the role of volume excess. Am J Nephrol. 2011;34(4):381-90. doi: 10.1159/000331067. Epub 2011 Sep 2.
- Background: PubMed 17699282Brennan JM, Ronan A, Goonewardena S, Blair JE, Hammes M, Shah D, Vasaiwala S, Kirkpatrick JN, Spencer KT. Handcarried ultrasound measurement of the inferior vena cava for assessment of intravascular volume status in the outpatient hemodialysis clinic. Clin J Am Soc Nephrol. 2006 Jul;1(4):749-53. doi: 10.2215/CJN.00310106. Epub 2006 May 24.
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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.
Loke Meng Ong, FRCP principal investigator
Penang Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dextrose 5% and normal saline in people with End-Stage Kidney Disease and Hemodialysis, run by Penang Hospital, Malaysia at 15 sites in Malaysia.
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 5 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Malaysia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Loke Meng Ong, FRCP (+60-04-2225333 ext. 5767, onglokemeng@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
systolic blood pressure control (time frame: Time from week 0 until week 12). 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 NCT02590081, 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 28 Oct 2015.