A randomised controlled crossover trial of biofeedback control of end-dialysis plasma conductivity versus progressive reduction of dialysate conductivity.
| ISRCTN | ISRCTN32121550 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32121550 |
| Protocol serial number | N0077135300 |
| 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
- 21/04/2011
- 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
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 objectives | Does Diacontrol improve haemodynamic stability in comparison with fixed dialysate sodium achieving identical end-dialysis plasma conductivity? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urological and Genital Diseases: Renal |
| Intervention | We propose to randomise patients to serial reduction of fixed dialysate conductivity or to reduction of end-dialysis plasma conductivity achieved using a biofeedback loop (Diacontrol). Diacontrol monitors plasma conductivity and adjusts dialysate conductivity to achieve a prescribed end-dialysis plasma conductivity. This should deliver a specific end-dialysis total body sodium, thus automatically adjusting for variation in interdialytic kietary sodium intake. Haemodynamic stability on dialysis should be improved with this technique, allowing more patients to reap the benefits of low dialysate conductivity. Two groups of patients will have either Diacontrol or fixed dialysate conductivity. After serial reduction, the groups will cross over to the other modality. At the end of the trial all patients will revert to the unit standard dialysate of 13.6 mS/cm. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. End-dialysis plasma conductivity |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 18/05/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 32 |
| Key inclusion criteria | Chronic haemodialysis patients |
| Key exclusion criteria | 1. > 2 episodes of hypotension/week on current dialysis 2. On HDF |
| Date of first enrolment | 18/12/2003 |
| Date of final enrolment | 18/05/2004 |
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2007 | Yes | No |
