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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prismaflex HF20 cohort | Data collected from this study Pediatrics (weighing between 8 and 20 kg) who received CRRT with Prismaflex HF20 between 2008 to current in Canada or between 2020 to current in the US |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prismaflex HF20 | Device | CRRT fluid management and reduction of uremic toxins. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival to CRRT discontinuation | The proportion of patients who completed HF20/M60 based CRRT | 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) |
| Survival to ICU discharge | The proportion of patients who were released from the ICU | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| ICU length of stay | The duration of time (in days) patients were in the ICU | 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) |
| CRRT duration |
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Inclusion Criteria:
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 exclusion criteria for this study.
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Data from approximately 40 pediatric patients who had acute kidney injury (AKI), acute renal failure (ARF) or fluid overload requiring CRRT, weighed between 8 and 20 kg (17.6-44.1 lb), and were treated in the ICU with marketed HF20 based CRRT between 2008 to current in Canada or with HF20 product available under EUA between 2020 to current in the US, will be collected.
Data will be compared with a similar population (weighing 8-20 kg) from the ppCRRT registry who received CRRT with Prismaflex M60 sets.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham / Children's of Alabama | Birmingham | Alabama | 35233 | United States | ||
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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The duration of time (in days) HF20/M60 based CRRT was performed |
| 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) |
| AEs of relevance for HF20 | 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). | 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) |
| Lucile Packard Children's Hospital Stanford |
| Palo Alto |
| California |
| 94304 |
| United States |
| Ann and Robert H Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Seattle Children's Hospital Research and Foundation | Seattle | Washington | 98105 | United States |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |