Determinants of thiazide induced hyponatraemia in pre-exposed elderly - a controlled experiment
| ISRCTN | ISRCTN38727701 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38727701 |
| Secondary identifying numbers | N/A |
- Submission date
- 16/07/2007
- Registration date
- 16/07/2007
- Last edited
- 22/08/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Nanne Frenkel
Scientific
Scientific
Academic Medical Centre
Department of Vascular Medicine
Amsterdam
1105 AZ
Netherlands
| w.j.frenkel@amc.nl |
Study information
| Study design | Non-randomised, controlled experimental study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Thiazide-induced hyponatraemia is caused by impaired free water excretion either due to alterations in the Arginine Dihydrolase (ADH) - Arginine Vasopressin Receptor 2 (AVPR2) - Aquaporin-2 (AQP2) pathway or impaired renal sodium handling. |
| Ethics approval(s) | Ethics approval received from the Medical Ethics Committee of the AMC on the 16th August 2007 (ref: MEC 07/059). |
| Health condition(s) or problem(s) studied | Thiazide induced hyponatraemia |
| Intervention | All subjects included in this controlled experiment will receive a single dose of Hydrochloorthiazide 50 mg. After that they will be monitored for 24 hours. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Hydrochloorthiazide |
| Primary outcome measure | Effect of a single oral dose hydrochloorthiazide 50 mg intake on the serum and urine sodium, serum ADH, prostaglandin E2 and urinary aquaporin-2 excretion in elderly patients (aged 60 - 80 years) with previous thiazide-induced hyponatraemia (sodium less than 125 mmol/l) without another cause for their hyponatraemia and matched controls receiving a thiazide diuretic without hyponatraemia. Urinary hydrochlorothiazide concentrations are measured to analyse differences in thiazide metabolism. The response to ADH will be assessed by expression of AVPR2 in a cell-culture and determine its activity by measurement of cyclic Adenosine Monophospahte (cAMP). Outcomes will be measured at baseline (n = 0) and after 4, 8 and 24 hours. |
| Secondary outcome measures | To identify (elderly) patients who are at risk of thiazide induced hyponatraemia. Outcomes will be measured at baseline (n = 0) and after 4, 8 and 24 hours. |
| Overall study start date | 01/08/2007 |
| Completion date | 01/08/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Target number of participants | 36 |
| Key inclusion criteria | 1. Age 60 - 80 years 2. Previously admitted with thiazide-induced hyponatraemia 3. Patients must be willing and medically able to discontinue anti-hypertensive therapy six weeks before the study and for the duration of the study 4. Patients must be willing to be admitted for 24 hours and must be medically able to take the study medication 5. Patients must be willing to give informed consent |
| Key exclusion criteria | 1. Other causes for hyponatraemia (e.g. heart failure, pulmonary disease, medication associated with hyponatraemia) 2. Renal dysfunction (estimated clearance less than 50 ml/min according to Cockroft-Gault) 3. Liver cirrhosis 4. Heart failure 5. Medication: antipressiva (Selective Serotonin Reuptake Inhibitors [SSRIs]), antiepileptica, prednisone, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), opioids, other diuretics (e.g. lasix, burinex, chloorthalidon, dytac) 6. Allergy for sulphonamide derivates 7. Therapy resistant hypertension (Blood Pressure [BP] greater than 140/90 mmHg while using three or more anti-hypertensive drugs) |
| Date of first enrolment | 01/08/2007 |
| Date of final enrolment | 01/08/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Sponsor information
Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Vascular Medicine
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Website | http://www.amc.uva.nl#http://www.amc.uva.nl/ |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Charity
Dutch Kidney Foundation (Nierstichting Nederland) (The Netherlands)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Dutch Kidney Foundation
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
