Acute Kidney Injury (AKI), Acute Renal Failure (ARF), Fluid Overload in Dialysis Patients
Conditions
Keywords
Continuous Renal Replacement Therapy, CRRT
Brief summary
A retrospective multicenter, observational design intended to capture data on pediatrics (weighing between 8 - 20 kg) who underwent continuous renal replacement therapy (CRRT) using the HF20 set. Data will be compared with a similar population (weighting 8-20 kg) from the ppCRRT registry who received CRRT with Prismaflex M60 sets.
Detailed description
This study aims to compare patient outcomes after treatment with HF20 based CRRT to the historical ppCRRT registry. Data from eligible patient records will be collected, starting from January 2008 to most recent in Canada and from January 2020 to most recent in the US. The ppCRRT registry used a prospective observational format whereby de-identified data on patients and CRRT circuits were collected from 13 participating centers across the US between 2001 JAN 01 and 2005 AUG 31. The registry's primary outcome measure was patient survival to ICU discharge.
Interventions
DEVICEPrismaflex HF20
CRRT fluid management and reduction of uremic toxins.
Sponsors
Vantive Health LLC
Baxter Healthcare Corporation
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patient weighed between 8 and 20 kg (17.6 - 44.1 lb). 2. Patient received medical care in an intensive care unit (ICU) and was treated with HF20 based CRRT. 3. Patient had a clinical diagnosis of AKI or ARF or fluid overload requiring CRRT. Note: The cohort of patients treated with M60 sets from the ppCRRT registry (weighing 8 - 20 kg) are to meet inclusion criteria 1 and 3.
Exclusion criteria
There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival to CRRT discontinuation | From CRRT initiation up to CRRT discontinuation of the first record of CRRT treatment with HF20/M60 (from January 2008 to present in Canada, and from January 2020 to present in the US) | The proportion of patients who completed HF20/M60 based CRRT |
| Survival to ICU discharge | From ICU admission up to ICU discharge as related to of the first record of CRRT treatment with HF20/M60 (from January 2008 to present in Canada, and from January 2020 to present in the US) | The proportion of patients who were released from the ICU |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU length of stay | From ICU admission up to ICU discharge as related to of the first record of CRRT treatment with HF20/M60 (from January 2008 to present in Canada, and from January 2020 to present in the US) | The duration of time (in days) patients were in the ICU |
| CRRT duration | From CRRT initiation up to CRRT discontinuation of the first record of CRRT treatment with HF20/M60 (from January 2008 to present in Canada, and from January 2020 to present in the US) | The duration of time (in days) HF20/M60 based CRRT was performed |
| AEs of relevance for HF20 | From CRRT initiation up to CRRT discontinuation of the first record of CRRT treatment with HF20 (from January 2008 to present in Canada, and from January 2020 to present in the US) | AEs of relevance (non-serious and serious) documented in the patient's medical records that occurred during HF20 based CRRT treatment within the collection period (i.e., from 2008 to present for patients in Canada or 2020 to present for US patients). |
Countries
United States
Outcome results
None listed