NCT02165072

Brief Summary

This is an observational study that will examine the possibility of determining the type of Acute Kidney Injury (AKI) using bedside ultrasound machines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2014

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

February 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
9 months until next milestone

Results Posted

Study results publicly available

June 23, 2016

Completed
Last Updated

June 23, 2016

Status Verified

June 1, 2016

Enrollment Period

1.7 years

First QC Date

June 13, 2014

Results QC Date

November 2, 2015

Last Update Submit

June 21, 2016

Conditions

Keywords

Inferior vena cavaKidney injuryUltrasound

Outcome Measures

Primary Outcomes (2)

  • Maximum and Minimum Diameters of the Inferior Vena Cava in Patients With Acute Kidney Injury

    The investigators will measure the maximum and minimum diameters of the inferior vena cava with patients with acute kidney injury.

    Day 1 of ICU admission

  • Percent Collapse of the Inferior Vena Cava in Patients With Acute Kidney Injury

    The investigators will measure the maximum and minimum diameters of the inferior vena cava with patients with acute kidney injury and calculate the percent change between the maximum and minimum diameters.

    Day 1 of ICU admission

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects ages 18-89 years with AKI (creatinine of 1.7mg/100ml or higher for less than 24 hours from baseline creatinine ≤1.2 or with unknown baseline creatinine). Standard of care treatment will not be different for patients taking part in this study. Participants will have bedside ultrasounds on days 0, 1, and 3, and baseline and follow-up data will be collected from medical records.

You may qualify if:

  • Creatinine of 1.7 mg/100ml or higher for less than 24 hours from baseline creatinine ≤1.2 or with unknown baseline creatinine
  • Age range: 18-89 years
  • Age range ≥ 18

You may not qualify if:

  • \. Only chronic renal disease will exclude a patient from our study regardless of past medical history and medications they are taking. (For the purposes of this study, any patient with creatinine higher than 1.2 mg /100ml for more than 24 hours will be identified as having chronic renal disease.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech Univrsity Health Science Center

Lubbock, Texas, 79430, 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

Limitations and Caveats

This study is straightforward and involves measurements of the inferior vena cava. The study population was heterogeneous. Study measurements depend on the ability to identify the inferior vena cava with precision and make accurate measurements.

Results Point of Contact

Title
Dr Kenneth Nugent
Organization
Texas Tech university Health Sciences Center, Lubbock, TX

Study Officials

  • Kenneth M Nugent, MD

    Texas Tech University Health Sciences Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2014

First Posted

June 17, 2014

Study Start

February 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

June 23, 2016

Results First Posted

June 23, 2016

Record last verified: 2016-06

Locations