NCT02064244

Brief Summary

Bedside ultrasonographic assessment of IVC size and IVC collapsibility index can be used to guide the management of patients with acute kidney injury with and without volume overload in the intensive care unit

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2014

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

February 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 17, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 9, 2016

Status Verified

June 1, 2016

Enrollment Period

2.2 years

First QC Date

February 6, 2014

Last Update Submit

June 8, 2016

Conditions

Keywords

renalkidneycreatinineInferior Vena Cava (IVC)Acute Renal Failure (ARF)Acute Kidney Injury (AKI)

Outcome Measures

Primary Outcomes (1)

  • percentage of patients with improved Creatinine level in group 1 and 2

    percentage of patients with improved Creatinine level in group 1 and 2

    48 hours

Secondary Outcomes (1)

  • glomerular filtration rate (GFR), changes in hemodynamic parameters (mean arterial blood pressure, urine output, pressors requirement )and Partial oxygen pressure (PO2) /Fio2 in group 1 and group 2

    24 and 48 hours

Study Arms (1)

Acute renal failure in ICU

Ultrasound for measurement of Inferior Vena Cava size

Other: Ultrasound for measurement of Inferior Vena Cava size.

Interventions

Focused bedside ultrasound will be performed for each patient as part of their routine care and initial assessment. The IVC size will be measured at the subcostal window, during inspiration and expiration, using the Sonosite cardiac probe P-21 (5-1 MHZ). The measurement is obtained by applying the M-mode, perpendicular to the IVC axis and 2 cm caudal from its junction with the right atrium.

Acute renal failure in ICU

Eligibility Criteria

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

Consecutive patients presenting to the intensive care unit with a diagnosis of acute renal failure ( Defined as 1.5 fold increase in plasma creatinine level compared to baseline)

You may qualify if:

  • patients presenting to the intensive care unit with a diagnosis of acute renal failure (defined as a 1.5 fold increase in plasma Creatinine level compared to baseline)

You may not qualify if:

  • Age\<18 years
  • Hemodialysis or continuous renal replacement therapy(CRRT)
  • Untreated obstructive uropathy
  • Pulmonary emboli

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (1)

  • Jambeih R, Keddissi JI, Youness HA. IVC Measurements in Critically Ill Patients with Acute Renal Failure. Crit Care Res Pract. 2017;2017:3598392. doi: 10.1155/2017/3598392. Epub 2017 Sep 5.

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Houssein Youness, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 6, 2014

First Posted

February 17, 2014

Study Start

February 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 9, 2016

Record last verified: 2016-06

Locations