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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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The primary objective of this study is to evaluate the efficacy of the Gambro Prismaflex® HF20 Set based on testing the hypothesis that it delivers sufficient renal replacement therapy to effectively treat acute kidney injury (AKI) in pediatric patients by reducing blood urea nitrogen (BUN).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prismaflex HF20 CRRT | Experimental | Patients included in this arm will be treated for a minimum period of 20 of the first 24 hours and up to 72 hours with each Prismaflex® HF 20 Set with BUN, creatinine and bicarbonate being measured for statistical analysis at 12 hour intervals during CRRT treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prismaflex HF20 CRRT Filter | Device |
| ||
| Prismaflex® System 7.10 and 7.20 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in BUN (mg/dL) at 24 Hours Following Initiation of CRRT | Blood Urea Nitrogen (BUN) | 24 hours from CRRT initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Creatinine (Umol/L) at 24 Hours Following Initiation of CRRT | 24 hours from CRRT initiation | |
| Percent Change From Baseline in Bicarbonate (mmol/L) at 24 Hours Following Initiation of CRRT | 24 hours from CRRT initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing at Least One Prismaflex Alarms Related to Fluid Balance and Extracorpeal Life | The end of the extracorporeal circuit life will be defined by the occurrence of one or both of the following Prismaflex ® System alarms, after which CRRT will be terminated and the extracorporeal circuit replaced:
Alarms from Prismaflex ® System 7.10 related to fluid balance will be noted and recorded for the following alarms:
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucile Packard Children's Hospital Stanford | Stanford | California | 94305 | United States | ||
| University of Iowa Children's Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prismaflex HF20 CRRT | Patients included in this arm will be treated for a minimum period of 24 hours and up to 72 hours with each Prismaflex® HF 20 Set being measured for statistical analysis at 12 hour intervals during CRRT treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 6, 2017 | May 21, 2021 |
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| Device |
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| HF20 Set Filter Survival Time | Filters that were replaced any time CRRT was stopped for reasons other than the failure to mediate the two alarms specified were censored at their current duration of usage (filter clotted and TMP excessive). Only filters that were replaced due to the two alarms were considered events for this survival analysis. A total of 34 filters were used in the study and 22 filters were censored, leaving data from only 12 filters to complete the survival estimate. Due to the small amount of filter data available, only the 25th percentile survival estimate was used since the 50th and 75th percentiles were not reached. Filter life of filters were analyzed using a Kaplan Meier survival curve with quartile survival times after the start of CRRT. | Up to 72 Hours after Initiation |
| Up to 72 hours from CRRT initiation |
| Iowa City |
| Iowa |
| 52242 |
| United States |
| Helen DeVos Children's Hospital | Grand Rapids | Michigan | 49503 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Children's Medical Center of Dallas | Dallas | Texas | 75235 | United States |
| Seattle Children's Hospital - Divison of Nephrology | Seattle | Washington | 98105 | United States |
| COMPLETED |
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| NOT COMPLETED |
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The full analysis set (FAS) was based on the intent-to-treat (ITT) principle and includes any patient who received CRRT on the Prismaflex HF20 Set for any period of time.
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| ID | Title | Description |
|---|---|---|
| BG000 | Prismaflex HF20 CRRT | Patients included in this arm will be treated for a minimum period of 24 hours and up to 72 hours with each Prismaflex® HF 20 Set being measured for statistical analysis at 12 hour intervals during CRRT treatment. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline in BUN (mg/dL) at 24 Hours Following Initiation of CRRT | Blood Urea Nitrogen (BUN) | The full analysis set (FAS) was based on the intent-to-treat (ITT) principle and includes any patient who received CRRT on the Prismaflex HF20 Set for any period of time. Number of subjects (n=17) with evaluable data is shown, which is a subset of FAS (N=23). | Posted | Mean | Standard Deviation | Percent Change | 24 hours from CRRT initiation |
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| Secondary | Percent Change From Baseline in Creatinine (Umol/L) at 24 Hours Following Initiation of CRRT | FAS. Number of subjects (n) with evaluable data is shown. | Posted | Mean | Standard Deviation | Percent Change | 24 hours from CRRT initiation |
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| Secondary | Percent Change From Baseline in Bicarbonate (mmol/L) at 24 Hours Following Initiation of CRRT | FAS. Number of subjects (n) with evaluable data is shown. | Posted | Mean | Standard Deviation | Percent Change | 24 hours from CRRT initiation |
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| Secondary | HF20 Set Filter Survival Time | Filters that were replaced any time CRRT was stopped for reasons other than the failure to mediate the two alarms specified were censored at their current duration of usage (filter clotted and TMP excessive). Only filters that were replaced due to the two alarms were considered events for this survival analysis. A total of 34 filters were used in the study and 22 filters were censored, leaving data from only 12 filters to complete the survival estimate. Due to the small amount of filter data available, only the 25th percentile survival estimate was used since the 50th and 75th percentiles were not reached. Filter life of filters were analyzed using a Kaplan Meier survival curve with quartile survival times after the start of CRRT. | FAS | Posted | Number | 95% Confidence Interval | hours | Up to 72 Hours after Initiation | filters | filters |
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| Other Pre-specified | Number of Participants Experiencing at Least One Prismaflex Alarms Related to Fluid Balance and Extracorpeal Life | The end of the extracorporeal circuit life will be defined by the occurrence of one or both of the following Prismaflex ® System alarms, after which CRRT will be terminated and the extracorporeal circuit replaced:
Alarms from Prismaflex ® System 7.10 related to fluid balance will be noted and recorded for the following alarms:
| FAS | Posted | Number | participants | Up to 72 hours from CRRT initiation |
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Up to 24 hours prior to CRRT (Screening) through HF20 CRRT End (72 hours), for a total of up to 96 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prismaflex HF20 CRRT | Patients included in this arm will be treated for a minimum period of 24 hours and up to 72 hours with each Prismaflex® HF 20 Set being measured for statistical analysis at 12 hour intervals during CRRT treatment. | 2 | 23 | 5 | 23 | 16 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrest | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
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| Right Ventricular Failure | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
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| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
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| Intraventricular Haemorrhage | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Pulmonary Haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Pulmonary Hypertensive Crisis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Peripheral Ischaemia | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
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| BRADYCARDIA | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
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| HYPOTHERMIA | General disorders | MedDRA 18.0 | Systematic Assessment |
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| HEPATIC FAILURE | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
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| HEPATIC FUNCTION ABNORMAL | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
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| CITRATE TOXICITY | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
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| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
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| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
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| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
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| LACTIC ACIDOSIS | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
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| AGITATION | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
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| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
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Due to significant enrollment challenges, the study was terminated early before achieving the planned number of patients enrolled.
Baxter Healthcare Corporation reserves the right of prior review and approval of data from this study relative to the potential release of proprietary information to any publication or for any presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global CORP Clinical Trials Disclosure | Vantive | +1 2249484283 | Global.CORP.ClinicalTrialsDisclosure@vantive.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 30, 2018 | May 21, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| Asian |
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| Other |
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| Title | Denominators | Categories | ||||
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| filters |
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