Contact information
Type
Scientific
Primary contact
Dr Bruce Culleton
ORCID ID
Contact details
1403-29th St NW
Calgary
Alberta
T2N 2T9
Canada
+1403 944 8166
bruce.culleton@calgaryhealthregion.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
A laboratory prompt, which identifies a patient with chronic kidney disease (CKD) as being at high risk for cardiovascular disease and progression to kidney failure, improves the management of cardiovascular disease risk factors and kidney disease by physicians.
Ethics approval
Approved by Bioethics Committess at the University of Calgary and the University of Alberta, 2005, reference number: 18050
Study design
Cluster randomized trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Chronic kidney disease
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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.
Secondary outcome measures
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
Overall trial start date
01/04/2006
Overall trial end date
31/03/2008
Reason abandoned
Eligibility
Participant 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).
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
46 Family Practices per group (92 total)
Participant exclusion criteria
Those patients not meeting the inclusion criteria.
Recruitment start date
01/04/2006
Recruitment end date
31/03/2008
Locations
Countries of recruitment
Canada
Trial participating centre
1403-29th St NW
Alberta
T2N 2T9
Canada
Sponsor information
Organisation
Alberta Heritage Foundation for Medical Research (Canada)
Sponsor details
Suite 1500
10104-103 Avenue
Edmonton
T5J 4A7
Canada
+1 780 423 5727
ahfmrinfo@ahfmr.ab.ca
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Alberta Heritage Foundation for Medical Research (Canada)
Alternative name(s)
AHFMR
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Canada
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary