Clinical trial NCT02590081: Effect of Sodium Rinsing Fluid on Blood Pressure and Interdialytic Weight Change in Hemodialysis Patients
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: End-Stage Kidney Disease
Hemodialysis
Keywords: Normal saline
Destrose 5%
Blood pressure
Interdialytic weight gain
thirst level
End Stage Renal Failure
Lead sponsor: Penang Hospital, Malaysia
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Health, Malaysia
First posted: 2015-10-28
Enrollment: 434
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: systolic blood pressure control
timeFrame: Time from week 0 until week 12
Secondary outcomes:
measure: Interdialytic weight gain
timeFrame: Time from week 0 until week 12
measure: thirst level
timeFrame: Time from week 0 and week 12
measure: intradialytic event
timeFrame: Time from week 0 until week 12
measure: adverse events
timeFrame: Time from week 0 until week 12
Other outcomes:
Locations:
city: Alor Setar
country: Malaysia
facility: Hospital Sultanah Bahiyah, Alor Setar
state: Kedah
city: Seremban
country: Malaysia
facility: Hospital Tuanku Jaafar
state: Negeri Sembilan
city: Kuantan
country: Malaysia
facility: Hospital Tengku Ampuan Afzan
state: Pahang
city: Balik Pulau
country: Malaysia
facility: Hospital Balik Pulau
state: Penang
city: Bukit Mertajam
country: Malaysia
facility: Hospital Bukit Mertajam
state: Penang
city: George Town
country: Malaysia
facility: Penang Hospital
state: Penang
city: Kepala Batas
country: Malaysia
facility: Hospital Kepala Batas
state: Penang
city: Seberang Jaya
country: Malaysia
facility: Seberang Jaya Hospital
state: Penang
city: Sungai Bakap
country: Malaysia
facility: Hospital Sungai Bakap
state: Penang
city: Miri
country: Malaysia
facility: Miri Hospital
state: Sarawak
city: Selayang
country: Malaysia
facility: Selayang Hospital
state: Selangor
city: Serdang
country: Malaysia
facility: Hospital Serdang
state: Selangor
city: Cheras
country: Malaysia
facility: UKM Medical Centre
state: Wilayah persekutuan Kuala lumpur
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
state: Wilayah Persekutuan Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: UM Medical Centre
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
affiliation: Penang Hospital
name: Loke Meng Ong, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.