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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN26610787 |
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Date of registration:
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10/07/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Impact of Laboratory-based Prompts on the Management of Patients with Chronic Kidney Disease
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Scientific title:
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Date of first enrolment:
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01/04/2006 |
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Target sample size:
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92 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN26610787 |
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Study type:
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Interventional |
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Study design:
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Cluster randomized trial (Quality of life)
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Phase:
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Countries of recruitment
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Canada
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Contacts
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Name:
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Bruce
Culleton |
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Address:
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1403-29th St NW
Calgary
T2N 2T9
Alberta
Canada |
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Telephone:
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+1403 944 8166 |
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Email:
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bruce.culleton@calgaryhealthregion.ca |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: All patients >18 years of age who are registered with one of the participating general practices and have a GFR measured at <60 ml/min during the one-year study period will be included. All participating general practices will be geographically separated (not located in the same office building), and staffed by >1 full time practitioners who do not see outpatients in another general practice unit (to reduce the risk of contamination).
Exclusion criteria: Those patients not meeting the inclusion criteria.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic kidney disease
Nutritional, Metabolic, Endocrine
Kidney disease
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Intervention(s)
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The following prompt will be added to laboratory reports for patients who meet the inclusion criteria and are seen by a physician practice randomized to receive the prompt:
This patient has reduced kidney function and is at risk for cardiovascular events and progression to kidney failure. The National Kidney Foundation recommends:
1. Measure random urine albumin to creatinine (Alb:Cr) ratio
2. Institute an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) in patients with diabetes, or those with an Alb:Cr >35 mg/mmol
3. Referral to a nephrologist if GFR <30 ml/min/1.73 m^2
4. Assess and treat modifiable risk factors for cardiovascular (CV) and renal disease:
a. Target blood pressure (BP) less than 130/80 mmHg
b. Target low-density lipoprotein cholesterol(LDL-C) <2.5 mmol/l
c. If diabetic, target hemoglobin A1C (HbA1C) <7.0%
The above recommendations are general in nature and may not apply to all patients. Further information is available at http://www.akdn.info
The control group will receive usual care.
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Primary Outcome(s)
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Use of ACEi or ARB in patients >65 years of age with CKD who have a clear indication for ACEi or ARB use as defined by the presence of diabetes or significant albuminuria.
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Secondary Outcome(s)
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1. Use of an ACEi or ARB in patients >65 years of age with CKD
2. Subsequent measurement of lipids, hemoglobin A1C (in patients with diabetes, if not done in previous six months), urine protein or urine albumin, and subsequent frequency of measurement of serum creatinine
3. Referral to a specialist
4. Addition of cholesterol-lowering drugs in patients >65 years of age
5. Addition of new blood pressure medication(s) in patients >65 years of age
6. Health care costs
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Source(s) of Monetary Support
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Alberta Heritage Foundation for Medical Research (Canada)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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