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| Name | Class |
|---|---|
| Ministry of Health, Malaysia | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal saline | Active Comparator | Normal saline will be used for wash back procedure at the end of hemodiaysis. |
|
| dextrose 5% | Experimental | Dextrose 5% will be used for wash back procedure at the end of hemodiaysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextrose 5% | Drug |
| ||
| normal saline |
| Measure | Description | Time Frame |
|---|---|---|
| systolic blood pressure control | post intervention systolic blood pressure reduction compared to baseline | Time from week 0 until week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Interdialytic weight gain | reduced Interdialytic weight gain in experimental group | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Loke Meng Ong, FRCP | Contact | +60-04-2225333 | 5767 | onglokemeng@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Loke Meng Ong, FRCP | Penang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sultanah Bahiyah, Alor Setar | Alor Star | Kedah | 05460 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21893975 | Background | 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. | |
| 17699282 | Background | 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. |
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|
| 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. | Time from week 0 until week 12 |
| adverse events | All observed or spontaneously reported adverse events occur during the trial period. | Time from week 0 until week 12 |
| UKM Medical Centre | Cheras | Kuala Lumpur | 56000 | Malaysia |
|
| Hospital Kuala Lumpur | Kuala Lumpur | Kuala Lumpur | 50586 | Malaysia |
|
| UM Medical Centre | Kuala Lumpur | Kuala Lumpur | 59100 | Malaysia |
|
| Hospital Tuanku Jaafar | Seremban | Negeri Sembilan | 70300 | Malaysia |
|
| Hospital Tengku Ampuan Afzan | Kuantan | Pahang | 25100 | Malaysia |
|
| Hospital Balik Pulau | Balik Pulau | Pulau Pinang | 11000 | Malaysia |
|
| Hospital Bukit Mertajam | Bukit Mertajam | Pulau Pinang | 14000 | Malaysia |
|
| Penang Hospital | George Town | Pulau Pinang | 10990 | Malaysia |
|
| Hospital Kepala Batas | Kepala Batas | Pulau Pinang | 13200 | Malaysia |
|
| Seberang Jaya Hospital | Seberang Jaya | Pulau Pinang | 13700 | Malaysia |
|
| Hospital Sungai Bakap | Sungai Bakap | Pulau Pinang | 14200 | Malaysia |
|
| Miri Hospital | Miri | Sarawak | 98000 | Malaysia |
|
| Selayang Hospital | Selayang Baru Utara | Selangor | 68100 | Malaysia |
|
| Hospital Serdang | Serdang | Selangor | 43400 | Malaysia |
|
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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