Effects of Selfmonitoring on Outcome of Chronic Kidney Disease.

Effecten van het zelf monitoren van zoutinname op de uitkomst van de behandeling van patienten met een chronische nierziekte.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27687

Enrollment

150

Registered

2011-05-26

Start date

2011-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypertension, kidney, renovascular, self-management, psychological factors bloeddruk, nieren, zelfmanagement, psyologische factoren

Interventions

Two-arm multicenter open randomized controlled trial. Intervention period of 3 months, follow-up 6 months. Control and intervention group: All patients are informed about a sodium (salt) restricted d

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age at least 18 years; 2. Creatinin clearance between 90 and 20 ml/min/1.73m2; 3. Systolic bloodpressure higher than 135/85 mm Hg or a normal bloodpressure with antihypertensive treatment (at least 1 RAAS blockade); 4. Command of the Dutch language. 5. Proteinuria > 0.2 g/L or 0.3 g/24 h; 6. Last two sodium measurements > 120 mmol/24 h. A creatinine clearance of > 90 ml/min/1.73m2 is allowed if patients are treated for their kidney disease by an internist. The new criterion is ‘a creatinine clearance > 20 ml/min/1.73 m2’ (instead of ‘creatinine clearance between 90 and 20 ml/min/1.73m2’).

Exclusion criteria

Exclusion criteria: 1. Having undergone renal transplantation < 1 year ago 2. Acute renal failure; 3. Diabetes type 1; 5. Rapidly progressive glomerulonephritis; 6. Malignancy less than 5 years before inclusion; 7. A cardiovascular event less than 6 months before inclusion; 8. Participation in other clinical trials in which using medicine is part of the trial procedures; 9. Blood pressure higher than 180/100 mmHg; 10. Blood pressure lower than 125/75 mmHg.

Design outcomes

Primary

Measure	Time frame
1. Changes in sodium intake; 2. Changes in blood pressure.	—

Secondary

Measure	Time frame
1. Creatinine clearance; 2. Proteinuria/albuminuria; 3. Antihypertensive medication; 4. Psychological outcome measures.	—

Contacts

Public ContactS. Dijk, van

Dept. Medical Psychology, Leiden University Medical Center (LUMC) Albinusdreef 2

dijk@lumc.nl+31 (0)71-5273913

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)