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Failure to recruit patients further
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Purpose of this study is to evaluate the short-term hemodynamic effects of changes in blood flow rates in critically ill patients receiving continuous renal replacement therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | The patients will have the blood flow rate adjusted on CRRT gradually increased to assess the effect on hemodynamics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| continuous renal replacement therapy using System One (TM) setup (Nxstage) | Device | Participants who have been prescribed continuous renal replacement therapy will have hemodynamic parameters measured at various blood flow rates |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure Change | Change in mean arterial pressure from period 1 to period 2 | 10 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zafar Jamkhana, MD | Associate Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Louis University | St Louis | Missouri | 63110 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Arm | The patients will have the blood flow rate adjusted on CRRT gradually increased to assess the effect on hemodynamics continuous renal replacement therapy using System One (TM) setup (Nxstage): Participants who have been prescribed continuous renal replacement therapy will have hemodynamic parameters measured at various blood flow rates |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Arm | The patients will have the blood flow rate adjusted on CRRT gradually increased to assess the effect on hemodynamics continuous renal replacement therapy using System One (TM) setup (Nxstage): Participants who have been prescribed continuous renal replacement therapy will have hemodynamic parameters measured at various blood flow rates |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Blood Pressure Change | Change in mean arterial pressure from period 1 to period 2 | Posted | Mean | Standard Deviation | mmHg | 10 minutes |
|
|
40 minutes
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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 | Experimental Arm | The patients will have the blood flow rate adjusted on CRRT gradually increased to assess the effect on hemodynamics continuous renal replacement therapy using System One (TM) setup (Nxstage): Participants who have been prescribed continuous renal replacement therapy will have hemodynamic parameters measured at various blood flow rates |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Zafar Jamkhana | Saint Louis University | 314-577-8856 | zafar.jamkhana@health.slu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2018 | Feb 24, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| mean arterial pressure | Mean | Standard Deviation | mmHg |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |