Effect of Sodium Rinsing Fluid on Blood Pressure and Interdialytic Weight Change in Hemodialysis Patients
NCT ID: NCT02590081
Last Updated: 2015-10-28
Study Results
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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UNKNOWN
PHASE4
434 participants
INTERVENTIONAL
2015-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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Normal saline
Normal saline will be used for wash back procedure at the end of hemodiaysis.
normal saline
dextrose 5%
Dextrose 5% will be used for wash back procedure at the end of hemodiaysis.
Dextrose 5%
Interventions
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Dextrose 5%
normal saline
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
74 Years
ALL
No
Sponsors
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Ministry of Health, Malaysia
OTHER_GOV
Penang Hospital, Malaysia
OTHER_GOV
Responsible Party
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Dr.Ong Loke Meng
doctor
Principal Investigators
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Loke Meng Ong, FRCP
Role: PRINCIPAL_INVESTIGATOR
Penang Hospital
Locations
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Hospital Sultanah Bahiyah, Alor Setar
Alor Star, Kedah, Malaysia
UKM Medical Centre
Cheras, Kuala Lumpur, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, Malaysia
UM Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia
Hospital Tuanku Jaafar
Seremban, Negeri Sembilan, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, Malaysia
Hospital Balik Pulau
Balik Pulau, Pulau Pinang, Malaysia
Hospital Bukit Mertajam
Bukit Mertajam, Pulau Pinang, Malaysia
Penang Hospital
George Town, Pulau Pinang, Malaysia
Hospital Kepala Batas
Kepala Batas, Pulau Pinang, Malaysia
Seberang Jaya Hospital
Seberang Jaya, Pulau Pinang, Malaysia
Hospital Sungai Bakap
Sungai Bakap, Pulau Pinang, Malaysia
Miri Hospital
Miri, Sarawak, Malaysia
Selayang Hospital
Selayang Baru Utara, Selangor, Malaysia
Hospital Serdang
Serdang, Selangor, Malaysia
Countries
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Central Contacts
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Facility Contacts
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Loke Meng Ong
Role: primary
Anita Bhajan
Role: primary
Anita Bhajan
Role: primary
Anita Bhajan
Role: primary
References
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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.
Brennan 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.
Other Identifiers
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NMRR-14-950-20443
Identifier Type: -
Identifier Source: org_study_id
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