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Prismaflex HF20 Set and Prismaflex® System 7.10/7.20 for Acute Continuous Renal Replacement Therapy (CRRT) in Children

Primary Purpose

Acute Kidney Injury in Pediatric Patients

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Prismaflex HF20 CRRT Filter

Prismaflex® System 7.10 and 7.20

About this trial

This is an interventional treatment trial for Acute Kidney Injury in Pediatric Patients focused on measuring Acute Kidney Injury, Continuous Renal Replacement Therapy, Blood Urea Nitrogen (BUN), Prismaflex, Pediatric

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with a hospital admission body weight ≥8 and <20 kg (ie, ≥17.6 and <44.09 lbs).
Patients with AKI defined as either 1) AKI by the Kidney Disease Improving Global Outcomes (KDIGO) Acute Kidney Injury Guideline serum creatinine criteria, which is a >50% rise in serum creatinine over baseline or a 0.3 mg/dL SCr rise in 48 hours OR 2) as AKI by the Pediatric modified Risk, Injury, Failure, Loss, End-Stage Renal Disease (pRIFLE) criteria which is a 25% reduction in estimated creatinine clearance,16 OR 3) a serum creatinine >1.2 mg/dL. OR Patients with severe fluid overload, defined as a >10% fluid accumulation relative to the ICU admission.
Patients who have received RRT previously can be included in the study if >24 hours have elapsed since their previous RRT treatment.
Provide written informed consent from one or both parents, as required by the local IRB or legal guardians, unless one parent is deceased, unknown, incompetent or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child per 21 CFR Part 50.55(e).

Exclusion Criteria:

Patients a) weighing 8.0-20.0 kg with a hemoglobin of <7.0 g/dL, b) weighing 8.0-12.0 kg with a hemoglobin of <8.0 g/dL (unless blood prime used), and c) weighing 12.1-20.0 kg with a hemoglobin of <7.5 g/dL (unless blood prime used).
Children who are wards of the state.

Sites / Locations

Lucile Packard Children's Hospital Stanford
University of Iowa Children's Hospital
Helen DeVos Children's Hospital
Cincinnati Children's Hospital Medical Center
Children's Medical Center of Dallas
Seattle Children's Hospital - Divison of Nephrology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prismaflex HF20 CRRT

Arm Description

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.

Outcomes

Primary Outcome Measures

Percent Change From Baseline in BUN (mg/dL) at 24 Hours Following Initiation of CRRT

Blood Urea Nitrogen (BUN)

Secondary Outcome Measures

Percent Change From Baseline in Creatinine (Umol/L) at 24 Hours Following Initiation of CRRT

Percent Change From Baseline in Bicarbonate (mmol/L) at 24 Hours Following Initiation of CRRT

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.

Full Information

NCT ID

NCT02561247

First Posted

September 23, 2015

Last Updated

June 23, 2021

Sponsor

Baxter Healthcare Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02561247

Brief Title

Prismaflex HF20 Set and Prismaflex® System 7.10/7.20 for Acute Continuous Renal Replacement Therapy (CRRT) in Children

Official Title

Clinical Evaluation of the Prismaflex HF20 Set and Prismaflex® System 7.10 for Acute CRRT in Children

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Terminated

Study Start Date

November 10, 2015 (Actual)

Primary Completion Date

April 6, 2018 (Actual)

Study Completion Date

April 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Baxter Healthcare Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Kidney Injury in Pediatric Patients

Keywords

Acute Kidney Injury, Continuous Renal Replacement Therapy, Blood Urea Nitrogen (BUN), Prismaflex, Pediatric

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prismaflex HF20 CRRT

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Prismaflex HF20 CRRT Filter

Intervention Type

Device

Intervention Name(s)

Prismaflex® System 7.10 and 7.20

Primary Outcome Measure Information:

Title

Percent Change From Baseline in BUN (mg/dL) at 24 Hours Following Initiation of CRRT

Description

Blood Urea Nitrogen (BUN)

Time Frame

24 hours from CRRT initiation

Secondary Outcome Measure Information:

Title

Percent Change From Baseline in Creatinine (Umol/L) at 24 Hours Following Initiation of CRRT

Time Frame

24 hours from CRRT initiation

Title

Percent Change From Baseline in Bicarbonate (mmol/L) at 24 Hours Following Initiation of CRRT

Time Frame

24 hours from CRRT initiation

Title

HF20 Set Filter Survival Time

Description

Time Frame

Up to 72 Hours after Initiation

Other Pre-specified Outcome Measures:

Title

Number of Participants Experiencing at Least One Prismaflex Alarms Related to Fluid Balance and Extracorpeal Life

Description

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: Warning: Filter is Clotted, and/or Caution: TMP (Trans Membrane Pressure) Excessive Alarms from Prismaflex ® System 7.10 related to fluid balance will be noted and recorded for the following alarms: Caution: Flow Problem Caution: Gain Limit Reached Caution: Loss Limit Reached

Time Frame

Up to 72 hours from CRRT initiation

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with a hospital admission body weight ≥8 and <20 kg (ie, ≥17.6 and <44.09 lbs). Patients with AKI defined as either 1) AKI by the Kidney Disease Improving Global Outcomes (KDIGO) Acute Kidney Injury Guideline serum creatinine criteria, which is a >50% rise in serum creatinine over baseline or a 0.3 mg/dL SCr rise in 48 hours OR 2) as AKI by the Pediatric modified Risk, Injury, Failure, Loss, End-Stage Renal Disease (pRIFLE) criteria which is a 25% reduction in estimated creatinine clearance,16 OR 3) a serum creatinine >1.2 mg/dL. OR Patients with severe fluid overload, defined as a >10% fluid accumulation relative to the ICU admission. Patients who have received RRT previously can be included in the study if >24 hours have elapsed since their previous RRT treatment. Provide written informed consent from one or both parents, as required by the local IRB or legal guardians, unless one parent is deceased, unknown, incompetent or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child per 21 CFR Part 50.55(e). Exclusion Criteria: Patients a) weighing 8.0-20.0 kg with a hemoglobin of <7.0 g/dL, b) weighing 8.0-12.0 kg with a hemoglobin of <8.0 g/dL (unless blood prime used), and c) weighing 12.1-20.0 kg with a hemoglobin of <7.5 g/dL (unless blood prime used). Children who are wards of the state.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Baxter Study Director

Organizational Affiliation

Baxter Healthcare Corporation

Official's Role

Study Director

Facility Information:

Facility Name

Lucile Packard Children's Hospital Stanford

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

University of Iowa Children's Hospital

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

Helen DeVos Children's Hospital

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49503

Country

United States

Facility Name

Cincinnati Children's Hospital Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Facility Name

Children's Medical Center of Dallas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Facility Name

Seattle Children's Hospital - Divison of Nephrology

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Prismaflex HF20 Set and Prismaflex® System 7.10/7.20 for Acute Continuous Renal Replacement Therapy (CRRT) in Children

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