Hemodynamic Effects of Blood Flow Variation in Continuous Renal Replacement Therapy

Acute Kidney Injury Clinical Trial

Official title:

Hemodynamic Effects of Blood Flow Variation in Continuous Renal Replacement Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03078504
• Other study ID #: 26817
• Status: Terminated
• Phase: N/A
• Start date: February 17, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: March 2020
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: June 30, 2018
• Est. primary completion date: June 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• End-stage Renal Disease
• Kidney Failure, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	Saint Louis University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure Change	Change in mean arterial pressure from period 1 to period 2	10 minutes