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| autoid | 2 |
| crg_id | CRG050600002 |
| titleoftrial | A RANDOMIZED, CONTROLLED TRIAL OF FLUDROCORTISONE FOR THE TREATMENT OF HYPERKALAEMIA IN HAEMODIALYSIS PATIENTS |
| acronymnoftrial | |
| website | http:// |
| identificationno | |
| leadprefix | Prof |
| leadsurname | Johnson |
| leadgivennames | David Wayne |
| leadposition | Director |
| leaddepartment | Department of Nephrology |
| leadorganisation | Princess Alexandra Hospital |
| leadaddress | Ipswich Road, Woolloongabba, Brisbane Qld Australia 4102 |
| leademail | david_johnson@health.qld.gov.au |
| leadphone | +61 7 3240 5080 |
| leadfax | +61 7 3240 5480 |
| leadsuffix | |
| contactprefix | |
| contactsurname | |
| contactgivennames | |
| contactposition | |
| contactdepartment | |
| contactorganisation | |
| contactaddress | |
| contactemail | |
| contactphone | |
| contactfax | |
| funding | other |
| otherfunding | Renal Research Trust Fund |
| fundingnameofsponsors | Queensland Health |
| ethicsapproval | yes |
| studytype | randomised |
| studytype_other | |
| groupassignment | parallel |
| blinding_patients | no |
| blinding_investigators | no |
| blinding_outcomes | no |
| blinding_analysts | no |
| proposedstart | June 2004 |
| actualstart | June 2004 |
| proposedcompletiondate | August 200 |
| actualcompletiondate | August 200 |
| multi_center_study | no |
| numberofcentres | |
| multi_national_study | no |
| countrycentres | Australia |
| researchquestion | To determine whether oral fludrocortisone (0.1 mg/day) results in significant lowering of serum potassium concentrations in hyperkalaemic haemodialysis patients. |
| study_status_recruitment | no_longer_recruiting |
| study_status_recruitment_follow | ongoing |
| healthcarecondition | End-stage renal failure on haemodialysis |
| intervention1 | oral fludrocortisone (0.1 mg/day) |
| intervention2 | no fludrocortisone |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | adults |
| age | 18 - no upper age limit |
| totalrecruitment | 40 |
| inclusion | 1. Patients receiving haemodialysis. 2. Pre-dialysis potassium concentration > 4.5 mmol/L and < 7.0 mmol/L. 3. 18 years or over. 4. Able to give informed consent. |
| exclusion | 1. Patients with a history of psychological illness or condition which interferes with their ability to understand or comply with the requirements of the study. 2. Pregnancy or breast-feeding. 3. Known hypersensitivity to fludrocortisone. |
| primaryoutcomes | The primary outcome measure will be serum potassium concentration. |
| secondaryoutcomes | Secondary outcome measures will include resonium powder prescription, hospitalisations due to hyperkalaemia, average interdialytic weight gain, mean pre-dialysis blood pressure and serum sodium, chloride and bicarbonate. |
| reference |