Comparing two types of continuous renal replacement therapy in pediatric patients
Comparison of Patient Outcomes Between Retrospective Prismaflex HF20 Set and Historical Prospective Pediatric Continuous Renal Replacement Therapy (ppCRRT) Registry
Baxter Healthcare Corporation · NCT06633029
This study looks at how well two different types of kidney treatment work for young patients with kidney failure to see which helps them survive better in the ICU.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 106 (estimated) |
| Sex | All |
| Sponsor | Baxter Healthcare Corporation (industry) |
| Locations | 6 sites (Palo Alto, California and 5 other locations) |
| Trial ID | NCT06633029 on ClinicalTrials.gov |
What this trial studies
This observational study analyzes data from pediatric patients weighing between 8 to 20 kg who underwent continuous renal replacement therapy (CRRT) using the Prismaflex HF20 set. The study compares outcomes from this group to a similar cohort from the ppCRRT registry that received treatment with the Prismaflex M60 sets. Data will be collected retrospectively from medical records starting from January 2008 in Canada and January 2020 in the US, focusing on patient survival to ICU discharge. The aim is to evaluate the effectiveness of the HF20 set in treating acute renal failure and fluid overload in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients aged between 8 to 20 kg who are receiving CRRT in an ICU setting.
Not a fit: Patients outside the weight range of 8 to 20 kg or those not requiring CRRT will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective CRRT methods for pediatric patients with acute renal failure.
How similar studies have performed: Previous studies using similar observational approaches have provided valuable insights into CRRT effectiveness, suggesting potential for meaningful findings in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
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 exclusion criteria for this study.
Where this trial is running
Palo Alto, California and 5 other locations
- Lucile Packard Children's Hospital Stanford — Palo Alto, California, United States (RECRUITING)
- Children's Hospital Colorado — Aurora, Colorado, United States (NOT_YET_RECRUITING)
- Ann and Robert H Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (NOT_YET_RECRUITING)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (RECRUITING)
- Children's Medical Center of Dallas — Dallas, Texas, United States (NOT_YET_RECRUITING)
- Seattle Children's Hospital Research and Foundation — Seattle, Washington, United States (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Baxter CORP Clinical Trials Disclosure
- Email: Global_CORP_ClinicalTrialsDisclosure@baxter.com
- Phone: (224) 948-7359
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Renal Failure, Acute Kidney Injury, Fluid Overload in Dialysis Patients, Continuous Renal Replacement Therapy, CRRT