Study into achievement of isonatric haemodialysis by individual tailoring of dialysate sodium according to ionic mass balance derived from online conductance monitoring
| ISRCTN | ISRCTN71215609 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71215609 |
| Protocol serial number | N0077114320 |
| Sponsor | Department of Health |
| Funder | Derby Hospitals NHS Foundation Trust (UK) NHS R&D Support Funding |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 16/04/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
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 Chris W McIntyre
Scientific
Scientific
Derby Hospitals NHS Foundation Trust
Department of Nephrology
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Study into achievement of isonatric haemodialysis by individual tailoring of dialysate sodium according to ionic mass balance derived from online conductance monitoring |
| Study objectives | Whether or not individualising dialysate sodium has beneficial effects on haemodialysis patients interdialytic weight gains, blood pressure and thirst when compared to standard dialysate sodium. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urological and Genital Diseases: Renal dialysis |
| Intervention | The two groups will both undergo a 1-week period of initial data collection while being maintained on routine dialysis. Dialysis will be performed using a default dialysate sodium of 140 mmol/l. The first group will then continue to dialyse against a standard dialysate sodium concentration of 140 mmol/l, while the second group undergoes a period of 1 month of sequential reduction of dialysate sodium according to online conductivity monitoring, aiming for isonatric dialysis (i.e. Ionic mass balance of 0-100 mmol of sodium). This will then be maintained for a period of one month. After that time, there will be a crossover period of adjustment, during which the first group will have their dialysate sodium tailored to their requirements, and the second group will revert in a gradual manner to a dialysate sodium of 140 mmol/l. Again the two groups will be maintained for a further month, before both groups revert to a standard dialysate sodium at the end of the study. |
| Intervention type | Other |
| Primary outcome measure(s) |
Neutral sodium balance as assessed by ionic mass balance reduction in interdialytic weight gain. |
| Key secondary outcome measure(s) |
Pre and post dialysis blood pressure, number of anti-hypertensive agents stability on dialysis, thirst score. |
| Completion date | 23/03/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 100 |
| Key inclusion criteria | Patients on routine haemodialysis |
| Key exclusion criteria | No documented exclusion criteria. Protocol specifies ALL patients on established haemodialysis. |
| Date of first enrolment | 23/09/2002 |
| Date of final enrolment | 23/03/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Derby Hospitals NHS Foundation Trust
Derby
DE22 3NE
United Kingdom
DE22 3NE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
