Hemodynamic Effects of Blood Flow Variation in Continuous Renal Replacement Therapy

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.

Study Overview

• Status: Terminated
• Conditions: Acute Kidney Injury; End-stage Renal Disease
• Intervention / Treatment: Device: continuous renal replacement therapy using System One (TM) setup (Nxstage)

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Saint Louis University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental arm; The patients will have the blood flow rate adjusted on CRRT gradually increased to assess the effect on hemodynamics	Device: 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; Other Names: NxStage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure Change	Change in mean arterial pressure from period 1 to period 2	10 minutes

Collaborators and Investigators

• Sponsor: St. Louis University
• Investigators: Principal Investigator: Zafar Jamkhana, MD, Associate Professor

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2017
• Primary Completion (Actual): June 6, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: March 8, 2017
• First Submitted That Met QC Criteria: March 8, 2017
• First Posted (Actual): March 13, 2017

Study Record Updates

• Last Update Posted (Actual): March 30, 2020
• Last Update Submitted That Met QC Criteria: March 27, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Acute Kidney Injury
• Other Study ID Numbers: 26817

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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