NCT02200120

Brief Summary

The purpose of this study is to examine the placement, timing, associated complications, efficacy of temporary and tunneled catheters for renal replacement therapy in patient with acute kidney injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

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

January 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 21, 2015

Status Verified

July 1, 2015

Enrollment Period

2.4 years

First QC Date

July 21, 2014

Last Update Submit

July 20, 2015

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • Dialysis adequacy

    Adequacy will be measured using urea reduction ratio for patients on intermittent hemodialysis. For continuous renal replacement therapy, we will record the maximum blood flow rate achievable. These measurements/recordings will be made on average within 1-3 days of starting therapy.

    up to 7d after starting renal replacement therapy

Secondary Outcomes (1)

  • blood stream infection rates

    within 30d of catheter placement

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to the hospital with acute kidney injury requiring renal replacement therapy

You may qualify if:

  • Patients admitted to the hospital with acute kidney injury requiring renal replacement therapy

You may not qualify if:

  • End stage renal disease
  • Chronic kidney disease 5 progression to end stage renal disease
  • Outside hospital catheter placement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Sushrut Waikar, MD, MHS

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

  • Mallika L Mendu

    Brigham and Women's Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 21, 2014

First Posted

July 25, 2014

Study Start

January 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 21, 2015

Record last verified: 2015-07

Locations

US(1)