NCT04762524

Brief Summary

The investigators plan to start patients who need CRRT on either CVVH or CVVHD by block randomization, and then to measure filter life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2021

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

12 months

First QC Date

February 1, 2021

Last Update Submit

March 15, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Filter Life

    Number of hours on average until filter clots

    Until CRRT discontinuation, on average 4-5 days

Secondary Outcomes (1)

  • Mortality

    Through hospital discharge, on average 2-4 weeks

Study Arms (2)

Initiation on CVVH

EXPERIMENTAL

Patients in this arm were initiated on CVVH, rather than CVVHD

Other: CVVH vs CVVHD

Initiation on CVVHD

ACTIVE COMPARATOR

Patients in this arm were initiated on CVVHD, rather than CVVHDH

Other: CVVH vs CVVHD

Interventions

Patients are initiated on CRRT in either the CVVH or CVVHD modality

Initiation on CVVHInitiation on CVVHD

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Adult patients initiated on CRRT at University of Iowa Hospital

You may not qualify if:

  • Prisoners
  • Minors
  • ECMO use at the time of CRRT initiation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

  • Mann L, Ten Eyck P, Wu C, Story M, Jenigiri S, Patel J, Honkanen I, O'Connor K, Tener J, Sambharia M, Fraer M, Nourredine L, Somers D, Nizar J, Antes L, Kuppachi S, Swee M, Kuo E, Huang CL, Jalal DI, Griffin BR. CVVHD results in longer filter life than pre-filter CVVH: Results of a quasi-randomized clinical trial. PLoS One. 2023 Jan 11;18(1):e0278550. doi: 10.1371/journal.pone.0278550. eCollection 2023.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

February 1, 2021

First Posted

February 21, 2021

Study Start

March 21, 2020

Primary Completion

March 1, 2021

Study Completion

March 11, 2021

Last Updated

March 16, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations