Hemodynamic Effects of Blood Flow Variation in Continuous Renal Replacement Therapy

NCT03078504 | Terminated Results FDA Device

• 1 other identifier: 26817
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Blood Pressure Change

  Change in mean arterial pressure from period 1 to period 2

  10 minutes

Study Arms (1)

Experimental arm

EXPERIMENTAL

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)

Interventions

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

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

Also known as: NxStage

Experimental arm

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr.Zafar Jamkhana
• Organization: Saint Louis University

zafar.jamkhana@health.slu.edu

314-577-8856

Study Officials

• Zafar Jamkhana, MD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 13, 2017
• Study Start: February 17, 2017
• Primary Completion: June 6, 2018
• Study Completion: June 30, 2018
• Last Updated: March 30, 2020
• Results First Posted: March 30, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)