Back to resultsHemodynamic Effects of Blood Flow Variation in Continuous Renal Replacement Therapy
Primary Purpose
Acute Kidney Injury, End-stage Renal Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
continuous renal replacement therapy using System One (TM) setup (Nxstage)
Sponsored by
About this trial
This is an interventional treatment trial for Acute Kidney Injury
Eligibility Criteria
Inclusion Criteria:
- Age 18-89
- Acute renal failure or end-stage renal disease necessitating CRRT
- Admitted to the MICU service
- If on vasopressor/inotropic agent, norepinephrine as only intravenous pressor
- If on vasopressor/inotropic agent, at stable pressor dose for at least four hours
- If on IV fluids, stable dose of crystalloids <= 100cc/hour and is not receiving colloids for 4 hours or more prior to initiation of CRRT
- Mean arterial pressure (MAP) >= 65
- Arterial catheter present for continuous blood pressure monitoring
- CRRT duration of 48 hours or less using NxStage System One dialysis system
- successfully tolerated CRRT for at least 4 hours without clotting or hemodynamic instability
- no other procedures, blood products transfusion, or additional medication administration are anticipated during the study period
Exclusion Criteria:
- listed for organ transplant
- atrial fibrillation, other irregular heart rhythm, unstable arrhythmia
- need for more than one intravenous vasopressor agent
- intravenous vasopressor/inotropic agent other than norepinephrine (ie dobutamine, dopamine, vasopressin, epinephrine)
- therapeutic anticoagulation being administered
- known acute myocardial infarction as defined by elevated troponin along with a documented clinical diagnosis during current hospitalization
- known acute stroke, intracerebral hemorrhage, intracranial mass effect, or elevated intracranial pressure within the last 30 days.
- dialysis catheter malfunction and unable to maintain target blood flow rate
- fluid removal (ultrafiltration) rate > 100mL/hour
Sites / Locations
- Saint Louis University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental arm
Arm Description
The patients will have the blood flow rate adjusted on CRRT gradually increased to assess the effect on hemodynamics
Outcomes
Primary Outcome Measures
Blood Pressure Change
Change in mean arterial pressure from period 1 to period 2
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03078504
Brief Title
Hemodynamic Effects of Blood Flow Variation in Continuous Renal Replacement Therapy
Official Title
Hemodynamic Effects of Blood Flow Variation in Continuous Renal Replacement Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Failure to recruit patients further
Study Start Date
February 17, 2017 (Actual)
Primary Completion Date
June 6, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Louis University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, End-stage Renal Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
The patients will have the blood flow rate adjusted on CRRT gradually increased to assess the effect on hemodynamics
Intervention Type
Device
Intervention Name(s)
continuous renal replacement therapy using System One (TM) setup (Nxstage)
Other Intervention Name(s)
NxStage
Intervention Description
Participants who have been prescribed continuous renal replacement therapy will have hemodynamic parameters measured at various blood flow rates
Primary Outcome Measure Information:
Title
Blood Pressure Change
Description
Change in mean arterial pressure from period 1 to period 2
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-89
Acute renal failure or end-stage renal disease necessitating CRRT
Admitted to the MICU service
If on vasopressor/inotropic agent, norepinephrine as only intravenous pressor
If on vasopressor/inotropic agent, at stable pressor dose for at least four hours
If on IV fluids, stable dose of crystalloids <= 100cc/hour and is not receiving colloids for 4 hours or more prior to initiation of CRRT
Mean arterial pressure (MAP) >= 65
Arterial catheter present for continuous blood pressure monitoring
CRRT duration of 48 hours or less using NxStage System One dialysis system
successfully tolerated CRRT for at least 4 hours without clotting or hemodynamic instability
no other procedures, blood products transfusion, or additional medication administration are anticipated during the study period
Exclusion Criteria:
listed for organ transplant
atrial fibrillation, other irregular heart rhythm, unstable arrhythmia
need for more than one intravenous vasopressor agent
intravenous vasopressor/inotropic agent other than norepinephrine (ie dobutamine, dopamine, vasopressin, epinephrine)
therapeutic anticoagulation being administered
known acute myocardial infarction as defined by elevated troponin along with a documented clinical diagnosis during current hospitalization
known acute stroke, intracerebral hemorrhage, intracranial mass effect, or elevated intracranial pressure within the last 30 days.
dialysis catheter malfunction and unable to maintain target blood flow rate
fluid removal (ultrafiltration) rate > 100mL/hour
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zafar Jamkhana, MD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hemodynamic Effects of Blood Flow Variation in Continuous Renal Replacement Therapy
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