Acute kidney failure in babies weighing <8 kg Urological and Genital Diseases Congenital renal failure
Conditions
Interventions
Babies weighing up to 8 kg that need dialysis for acute renal failure and who would normally be treated with peritoneal dialysis (PD), will be studied for 4 days. During that time they will have 2 day
Sponsors
Newcastle upon Tyne University Hospital NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Being treated in Freeman Hospital Paediatric Intensive Care Unit 2. Weighing =8 kg 3. Being judged by the consultants in the clinical teams responsible for their care to require either dialysis or ultrafiltration, or both. This decision may be made on biochemical or other pathophysiological criteria, which will be documented.
Exclusion criteria
Exclusion criteria: Having an incomplete abdominal wall or recent abdominal surgery which would render PD impossible. These babies will be treated with the Newcastle infant HD machine on humanitarian grounds, but will not form part of the formal study. There will be no need to add extra grounds for non-inclusion, such as their survival chances or other co-morbidities. This is because the exclusion criteria already applied by the requesting medical team will have already have ruled out clinically inappropriate cases. These include a thorough holistic assessment of all babies for whom open-heart surgery is considered, and multidisciplinary discussions before additional therapies such as post-operative dialysis are requested.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Our primary question is whether the Newcastle HD machine will provide better clearance of the kidney marker creatinine than PD does in small babies. Creatinine clearance will be measured twice daily throughout the 4 days of the study by comparing the creatinine concentrations measured in blood samples taken for clinical reasons with the concentrations in waste dialysis fluid taken at the same time. The log10 geometric mean of the clearances on HD will be subtracted from the equivalent values on PD, producing a ratio of HD/PD clearances. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Whether the Newcastle HD machine will provide better clearance of the waste chemicals urea and phosphate than PD does in small babies. These clearances will be measured in parallel to the creatinine clearances. 2. Whether the Newcastle HD machine will provide greater and more precise control of fluid removal than PD does in small babies. This will be measured by comparing how closely the volumes removed each day compare to the prescribed clinical target. 3. Whether the Newcastle HD machine will be equally safe, and that it will be less time consuming and more convenient for the nursing staff to operate than PD. These will be assessed by recording all possible adverse events, and by a questionnaire to the medical and nursing staff on convenience of use and user preference. | — |
Countries
United Kingdom
Outcome results
None listed