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Effect of Sodium Rinsing Fluid on Blood Pressure and Interdialytic Weight Change in Hemodialysis Patients (NSD5)

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ClinicalTrials.gov Identifier: NCT02590081
Recruitment Status : Unknown
Verified October 2015 by Dr.Ong Loke Meng, Penang Hospital, Malaysia.
Recruitment status was:  Not yet recruiting
First Posted : October 28, 2015
Last Update Posted : October 28, 2015
Sponsor:
Collaborator:
Ministry of Health, Malaysia
Information provided by (Responsible Party):
Dr.Ong Loke Meng, Penang Hospital, Malaysia

Study Description
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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.


Condition or disease Intervention/treatment Phase
End-Stage Kidney Disease Hemodialysis Drug: Dextrose 5% Drug: normal saline Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 434 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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 Start Date : October 2015
Estimated Primary Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Normal saline
Normal saline will be used for wash back procedure at the end of hemodiaysis.
 Drug: normal saline
Experimental: dextrose 5%
Dextrose 5% will be used for wash back procedure at the end of hemodiaysis.
 Drug: Dextrose 5%


Outcome Measures
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Primary Outcome Measures :
  1. systolic blood pressure control [ Time Frame: Time from week 0 until week 12 ]
    post intervention systolic blood pressure reduction compared to baseline


Secondary Outcome Measures :
  1. Interdialytic weight gain [ Time Frame: Time from week 0 until week 12 ]
    reduced Interdialytic weight gain in experimental group

  2. thirst level [ Time Frame: Time from week 0 and week 12 ]
    Dialysis thirst inventory questionnaire to be administer by patient at baseline (week 0) and end of trial (week 12)

  3. intradialytic event [ Time Frame: Time from week 0 until week 12 ]
    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.

  4. adverse events [ Time Frame: Time from week 0 until week 12 ]
    All observed or spontaneously reported adverse events occur during the trial period.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02590081


Contacts
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Contact: Loke Meng Ong, FRCP +60-04-2225333 ext 5767 onglokemeng@gmail.com

Locations
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Malaysia
Hospital Sultanah Bahiyah, Alor Setar
Alor Setar, Kedah, Malaysia, 05460
Contact: Chen Hua Ching, MRCP    +60-04-7496898    nchching@yahoo.com   
Hospital Tuanku Jaafar
Seremban, Negeri Sembilan, Malaysia, 70300
Contact: Lily Mushahar, M.Med    +60 6-7684000    lilymushahar@hotmail.com   
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, Malaysia, 25100
Contact: Mohd Ramli Seman, M.Med    +60-09-5572222    mohdramliseman9@gmail.com   
Hospital Balik Pulau
Balik Pulau, Penang, Malaysia, 11000
Contact: Loke Meng Ong         
Hospital Bukit Mertajam
Bukit Mertajam, Penang, Malaysia, 14000
Contact: Anita Bhajan         
Penang Hospital
George Town, Penang, Malaysia, 10990
Contact: Ong Loke Meng, FRCS    00 604 2225333 ext 5767    onglokemeng@gmail.com   
Hospital Kepala Batas
Kepala Batas, Penang, Malaysia, 13200
Contact: Anita Bhajan         
Seberang Jaya Hospital
Seberang Jaya, Penang, Malaysia, 13700
Contact: Anita Bhajan    +60-04-3827496    abmanocha1518@gmail.com   
Hospital Sungai Bakap
Sungai Bakap, Penang, Malaysia, 14200
Contact: Anita Bhajan         
Miri Hospital
Miri, Sarawak, Malaysia, 98000
Contact: Keng Hee Koh, MRCP(UK)    +60-85-420033    kohkenghee@yahoo.com   
Selayang Hospital
Selayang, Selangor, Malaysia, 68100
Contact: Hin Seng Wong, FRCP    +60-03-61367788    hinseng@gmail.com   
Hospital Serdang
Serdang, Selangor, Malaysia, 43400
Contact: Bak Leong Goh, FRCP    +60-03-89475555    bak.leong@gmail.com   
UKM Medical Centre
Cheras, Wilayah persekutuan Kuala lumpur, Malaysia, 56000
Contact: Abdul Halim Abdul Gafor, M.Med    +60-03-91456074    halimgafor@gmail.com   
Hospital Kuala Lumpur
Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 50586
Contact: Ghazali Ahmad Kutty, M.Med    +60-03-26155380    ghazaliahmad@moh.gov.my   
UM Medical Centre
Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 59100
Contact: Soo Kun Lim    +60-0379492497    sookun_73@yahoo.com   
Sponsors and Collaborators
Penang Hospital, Malaysia
Ministry of Health, Malaysia
Investigators
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Principal Investigator: Loke Meng Ong, FRCP Penang Hospital
More Information
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Publications:

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Responsible Party: Dr.Ong Loke Meng, doctor, Penang Hospital, Malaysia
ClinicalTrials.gov Identifier: NCT02590081    
Other Study ID Numbers: NMRR-14-950-20443
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015
Keywords provided by Dr.Ong Loke Meng, Penang Hospital, Malaysia:
Normal saline
Destrose 5%
Blood pressure
 Interdialytic weight gain
thirst level
End Stage Renal Failure
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency