Hemodynamic Effects of Blood Flow Variation in Continuous Renal Replacement Therapy

NCT ID: NCT03078504

Last Updated: 2020-03-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-17
• Study Completion Date: 2018-06-30

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.

Conditions

Acute Kidney Injury; End-stage Renal Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental arm

The patients will have the blood flow rate adjusted on CRRT gradually increased to assess the effect on hemodynamics

Group Type: EXPERIMENTAL

continuous renal replacement therapy using System One (TM) setup (Nxstage)

Intervention Type: DEVICE

Participants who have been prescribed continuous renal replacement therapy will have hemodynamic parameters measured at various blood flow rates

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

NxStage

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Louis University

OTHER

Sponsor Role: lead

Responsible Party

Zafar Jamkhana, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zafar Jamkhana, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

Saint Louis University

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

26817

Identifier Type: -

Identifier Source: org_study_id