Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/07/2007
Date assigned
16/07/2007
Last edited
22/08/2007
Prospective/Retrospective
Prospectively 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 Nanne Frenkel

ORCID ID

Contact details

Academic Medical Centre
Department of Vascular Medicine
Amsterdam
1105 AZ
Netherlands
w.j.frenkel@amc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

Ethics approval received from the Medical Ethics Committee of the AMC on the 16th August 2007 (ref: MEC 07/059).

Study design

Non-randomised, controlled experimental study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Hydrochloorthiazide

Primary outcome measures

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 trial start date

01/08/2007

Overall trial end date

01/08/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Not Specified

Target number of participants

36

Participant 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 [SSRI’s]), antiepileptica, prednisone, Non-Steroidal Anti-Inflammatory Drugs (NSAID’s), 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)

Recruitment start date

01/08/2007

Recruitment end date

01/08/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (The Netherlands)

Sponsor details

Department of Vascular Medicine
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl#http://www.amc.uva.nl/

Funders

Funder type

Charity

Funder name

Dutch Kidney Foundation (Nierstichting Nederland) (The Netherlands)

Alternative name(s)

Dutch Kidney Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Netherlands

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