Hemodynamic Effects of Blood Flow Variation in Continuous Renal Replacement Therapy

Not Applicable

Terminated

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

• Registration Number: NCT03078504
• Lead Sponsor: St. Louis University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-17
• Study First Submitted: 2017-03-08
• Study First Submitted QC: 2017-03-08
• Study First Posted: 2017-03-13
• Primary Completion: 2018-06-06
• Study Completion: 2018-06-30
• Disposition First Submitted: 2020-01-03
• Results First Submitted: 2020-02-24
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-27
• Disposition First Submitted QC: 2020-03-27
• Last Update Submitted: 2020-03-27
• Results First Posted: 2020-03-30
• Disposition First Posted: 2020-03-30
• Last Update Posted: 2020-03-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental arm	continuous renal replacement therapy using System One (TM) setup (Nxstage)	The patients will have the blood flow rate adjusted on CRRT gradually increased to assess the effect on hemodynamics

Primary Outcome Measures

Name	Time	Method
Blood Pressure Change	10 minutes	Change in mean arterial pressure from period 1 to period 2

Trial Locations

Locations (1)

Saint Louis University; 🇺🇸 Saint Louis, Missouri, United States