Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/02/2006
Date assigned
10/07/2006
Last edited
14/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ahfmr.ab.ca

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

Publication citations

Additional files

Editorial Notes