| Primary | Time to Occurrence of Selected Prismaflex® System Alarms/Conditions | The point estimate is time point (number of hours of the extracorporeal circuit life of a filter) at which (100-percentile)% filters are still surviving (i.e. number surviving divided by number at risk), based on the Kaplan-Meier method. For example, for the 25th percentile: after 33.18 hours, 75% of filters are still surviving. Given the early termination, this study was not powered to show statistically significant changes in efficacy endpoints. The Prismaflex M150 Set extracorporeal circuit life of filters were intended to be assessed over a maximum of 120 hours (Treatment Period) by duration of time for which each Prismaflex M150 Set could be used continuously over a maximum 72 hour time-period in each patient. The end of the extracorporeal circuit life was defined by the occurrence of one or both of the following Prismaflex® System alarms/conditions if the alarms could not be mitigated: (1) "Warning: Filter Clotted", and/or (2) "Advisory transmembrane pressure (TMP) Too High." | Full Analysis Set (FAS)-randomized treatment groups (intent-to-treat principle) | Posted | | Number | 95% Confidence Interval | hours | | Up to 120 hours post CRRT treatment initiation | | | | ID | Title | Description |
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| OG000 | Prismocitrate 18 | CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). | | OG001 | No Systemic Anticoagulation | CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). |
| | | Title | Denominators | Categories |
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| 25 Percentile | | | Title | Measurements |
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| - OG00033.180(8.340 to NA)Not reached due to early termination of study.
- OG00117.680(11.990 to 24.070)
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| | 50 Percentile | | |
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| Secondary | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | Systemic blood iCa concentrations | Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline and up to 120 hours post CRRT treatment initiation | | | | ID | Title | Description |
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| OG000 | Prismocitrate 18 | CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). | | OG001 | No Systemic Anticoagulation | CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). |
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| Secondary | Extracorporeal Circuit Ionized Calcium by Hour | Post-filter blood iCa concentrations will only be measured in the Prismocitrate 18 arm. The extracorporeal circuit (post-filter). | Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint. | Posted | | Mean | Standard Deviation | mmol/L | | Up to 120 hours post CRRT treatment initiation | | | | ID | Title | Description |
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| OG000 | Prismocitrate 18 | CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). |
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| Secondary | Delivery of Prescribed CRRT Dose by Day | Evaluates the efficacy of using Prismocitrate 18 in delivering the prescribed CRRT dose, with delivered dose based on (daily) average effluent rate divided by (daily) average weight and expressed as mL/kg/hour. | Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint. | Posted | | Mean | Standard Deviation | mL/kg/hour | | Up to 120 hours post CRRT treatment initiation | | | | ID | Title | Description |
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| OG000 | Prismocitrate 18 | CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). | | OG001 | No Systemic Anticoagulation | CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). |
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| Secondary | Number of Investigator Site Facilities That Passed Prismocitrate 18 Training Assessment | Training conducted on administration of Prismocitrate 18 to demonstrate the understanding of the user groups on how to use the solution by passing an assessment at the end of training. The user groups who needed to be assessed prior to use of Prismocitrate 18 in the clinical trial setting were to be comprised of physicians, nurses, and other clinicians who were part of prescribing, initiating or modifying treatment during the 120 hour Treatment Period. The training assessment was housed on a restricted access study website. Study personnel who completed the training assessment have a completion date listed which indicates that the individual received a passing score of 80% or better on the training assessment. | Physicians, nurses, and other clinicians who were part of prescribing, initiating or modifying treatment at each Investigator site. Staff at each site facility passed testing, but the overall number of participants is not known. No analysis of investigator training test scores were conducted as results for individual test questions were not retained for analysis. | Posted | | Number | | site facility staff | | Prior to study use of Prismocitrate 18 | site facilities | site facilities | | ID | Title | Description |
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| OG000 | Prismocitrate 18 | CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). |
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| Secondary | Change From Baseline in Serum Bicarbonate by Hour | | Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline and up to 120 hours post CRRT treatment initiation | | | | ID | Title | Description |
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| OG000 | Prismocitrate 18 | CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). | | OG001 | No Systemic Anticoagulation | CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). |
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| Secondary | Change From Baseline in pH by Hour | | Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint. | Posted | | Mean | Standard Deviation | pH | | Baseline and up to 120 hours post CRRT treatment initiation | | | | ID | Title | Description |
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| OG000 | Prismocitrate 18 | CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). | | OG001 | No Systemic Anticoagulation | CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). |
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| Secondary | Change From Baseline in Base Excess by Hour | | Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline and up to 120 hours post CRRT treatment initiation | | | | ID | Title | Description |
|---|
| OG000 | Prismocitrate 18 | CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). | | OG001 | No Systemic Anticoagulation | CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). |
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| Secondary | Change From Baseline in Blood Total Calcium Concentration by Hour | | Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline and up to 120 hours post CRRT treatment initiation | | | | ID | Title | Description |
|---|
| OG000 | Prismocitrate 18 | CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). | | OG001 | No Systemic Anticoagulation | CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). |
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| Secondary | Change From Baseline in Serum Sodium by Hour | | Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline and up to 120 hours post CRRT treatment initiation | | | | ID | Title | Description |
|---|
| OG000 | Prismocitrate 18 | CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). | | OG001 | No Systemic Anticoagulation | CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). |
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| Secondary | Change From Baseline in Serum Anion Gap by Hour | | Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline and up to 120 hours post CRRT treatment initiation | | | | ID | Title | Description |
|---|
| OG000 | Prismocitrate 18 | CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). | | OG001 | No Systemic Anticoagulation | CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). |
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| Secondary | Change From Baseline in Serum Magnesium by Hour | | Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline and up to 120 hours post CRRT treatment initiation | | | | ID | Title | Description |
|---|
| OG000 | Prismocitrate 18 | CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). | | OG001 | No Systemic Anticoagulation | CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). |
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| Secondary | Change From Baseline in Serum Phosphate by Hour | | Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline and up to 120 hours post CRRT treatment initiation | | | | ID | Title | Description |
|---|
| OG000 | Prismocitrate 18 | CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). | | OG001 | No Systemic Anticoagulation | CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). |
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| Secondary | Change From Baseline in Serum Potassium by Hour | | Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline and up to 120 hours post CRRT treatment initiation | | | | ID | Title | Description |
|---|
| OG000 | Prismocitrate 18 | CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). | | OG001 | No Systemic Anticoagulation | CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). |
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| Secondary | Change From Baseline in Serum Chloride by Hour | | Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline and up to 120 hours post CRRT treatment initiation | | | | ID | Title | Description |
|---|
| OG000 | Prismocitrate 18 | CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). | | OG001 | No Systemic Anticoagulation | CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). |
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| Secondary | Number of Participants With Bleeding Events | | | Posted | | Count of Participants | | Participants | | Up to 120 hours post CRRT treatment initiation | | | | ID | Title | Description |
|---|
| OG000 | Prismocitrate 18 | CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). | | OG001 | No Systemic Anticoagulation | CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). |
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| Secondary | Number of Participants by Number of Blood Transfusions | | | Posted | | Number | | participants | | Up to 120 hours post CRRT treatment initiation | | | | ID | Title | Description |
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| OG000 | Prismocitrate 18 | CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). | | OG001 | No Systemic Anticoagulation | CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). |
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| Secondary | Number of Participants Reporting Any Baxter Device/Product Related Adverse Events (Serious and Non-Serious) | | | Posted | | Number | | Events | | Up to 30 days post study CRRT treatment completion | | | | ID | Title | Description |
|---|
| OG000 | Prismocitrate 18 | CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). | | OG001 | No Systemic Anticoagulation | CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). |
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| Secondary | Change From Baseline in Blood Pressure at Last Visit | | | Posted | | Mean | Standard Deviation | mmHg | | Baseline and up to 120 hours post CRRT treatment initiation | | | | ID | Title | Description |
|---|
| OG000 | Prismocitrate 18 | CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). | | OG001 | No Systemic Anticoagulation | CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). |
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| Secondary | Change From Baseline in Respiratory Rate at Last Visit | | | Posted | | Mean | Standard Deviation | breaths/Min | | Baseline and up to 120 hours post CRRT treatment initiation | | | | ID | Title | Description |
|---|
| OG000 | Prismocitrate 18 | CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). | | OG001 | No Systemic Anticoagulation | CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). |
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| Secondary | Change From Baseline in Temperature at Last Visit | | | Posted | | Mean | Standard Deviation | degree celsius | | Baseline and up to 120 hours post CRRT treatment initiation | | | | ID | Title | Description |
|---|
| OG000 | Prismocitrate 18 | CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). | | OG001 | No Systemic Anticoagulation | CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). |
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| Secondary | Change From Baseline in Pulse at Last Visit | | | Posted | | Mean | Standard Deviation | beats/min | | Baseline and up to 120 hours post CRRT treatment initiation | | | | ID | Title | Description |
|---|
| OG000 | Prismocitrate 18 | CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). | | OG001 | No Systemic Anticoagulation | CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). |
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| Secondary | Change From Baseline in Total Calcium/iCa Ratio by Hour | | Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint. | Posted | | Mean | Standard Deviation | ratio | | Baseline and up to 120 hours post CRRT treatment initiation | | | | ID | Title | Description |
|---|
| OG000 | Prismocitrate 18 | CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). | | OG001 | No Systemic Anticoagulation | CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). |
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| Secondary | Number of Bleeding Events by Location | | | Posted | | Number | | Events | | Up to 120 hours post CRRT treatment initiation | | | | ID | Title | Description |
|---|
| OG000 | Prismocitrate 18 | CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). | | OG001 | No Systemic Anticoagulation | CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). |
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| Secondary | Duration of Bleeding Events | | | Posted | | Mean | Standard Deviation | Hours | | Up to 120 hours post CRRT treatment initiation | | | | ID | Title | Description |
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| OG000 | Prismocitrate 18 | CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). | | OG001 | No Systemic Anticoagulation | CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). |
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