Acute renal insufficiency or fluid overload Urological and Genital Diseases Renal and Urogenital/ Renal failure
Conditions
Interventions
I-KID is looking to find out which method of dialysis gives the best support to very small babies. 6 NHS Trusts in England have agreed to take part and collect information on babies treated with both
Sponsors
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 25/09/2019: 1. Patients in PICU with a body weight of 0.8-7.99 kg who require continuous RRT for acute renal insufficiency or fluid overload as part of their standard clinical care 2. Person with legal parental responsibility (PR) for the patient has provides written informed consent for the patient to take part in the study. This may be after the patient has started dialysis in an emergency situation to not delay any treatment. Previous inclusion criteria: 1. Patients in PICU with a body weight of 0.8 kg – 7.99 kg who require continuous RRT for acute renal insufficiency or fluid overload as part of their standard clinical care 2. Person with legal parental responsibility (PR) for the patient has provided written informed consent for the patient to take part in the study
Exclusion criteria
Exclusion criteria: 1. Patient with known chronic renal failure already on adequate RRT 2. Patient already established on adequate RRT for whom entry into the study would require additional central venous access, if that access is not clinically indicated 3. Patient has an underlying metabolic diagnosis, including hyper ammonaemia 4. Clinician makes a clinical decision that the patient should not receive RRT using NIDUS 5. Unable to receive written informed consent for data collection from a person with legal PR for the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The accuracy of dialysate fluid removal compared with prescription as measured by the following: For CVVH/D or NIDUS: weighing the dialysis bags at the beginning and end of a study period lasting as close to +6 h as is practically possible (tolerance 5 to 7 h) during phase 1 to identify the quantity of fluid removed, compared to the quantity that the clinicians prescribed to be removed For PD: volumetric measuring by the nursing staff of the volumes of dialysis fluid run into, and subsequently drained, from the babies’ abdomens during a complete number of dialysis cycles over a study period lasting as close to +6 h as is practically possible (tolerance 5 to 7 h) during phase 1 to identify the quantity of fluid removed, compared to the quantity that the clinicians prescribed to be removed | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Haemodynamic status (drop in blood pressure after connection requiring intervention), measured by the PICANet daily and enhanced data 2. Biochemical clearances, measured by clinical biochemistry testing (enzymatic creatinine, urea, phosphate) on the sample of waste dialysate fluid collected) at the same time the routine bloods are sent to the local laboratory for analysis during phase 1 and 2 3. Number of ventilator free days, measured/recorded in the PICAnet (daily and enhanced data) collected during phase 1, 2 and 3 4. Survival, measured at 1 month follow up (no longer than 3 months) 5. Completion of intended renal replacement therapy course, measured/recorded in the PICAnet (daily and enhanced data) collected during phase 3 6. Need for additional vascular or dialysis access, measured/recorded in the PICAnet (daily and enhanced data) collected during phase 1, 2 and 3 7. Unplanned change in circuits, measured in the PICAnet (daily and enhanced data) collected during phases 1, 2 and 3 8. Exposure to blood transfusion: extra clinical data, in addition to PICAnet, recorded during phase 1, 2 and 3 9. Bleeding events, measured/recorded in the PICAnet (daily and enhanced data) collected during phase 1, 2 and 3 10. Anticoagulant use, measured/recorded in the PICAnet (daily and enhanced data) collected during phase 1, 2 and 3 11. Parent/guardian experience, measured using questionnaires at an appropriate time before the patient is discharged from the PICU (any time up to the day of discharge) 12. Staff acceptability and usability of device, measured by questionnaire completion by staff who are using the NIDUS machine during the first 48 hours of dialysis | — |
Countries
England, United Kingdom
Outcome results
None listed