Inferior Vena Cava (IVC) Size in Acute Renal Failure

NCT ID: NCT02064244

Last Updated: 2016-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Consecutive 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 ).

Baseline characteristics will be recorded and followed for each patient, these include:

1. Demographics
2. Medical history
3. Hemodynamic parameter such as Central Venous Pressure (CVP), Mean Arterial Pressure (MAP) , and measurement of superior vena cava (SVC) size by ultrasound.
4. Laboratory parameter such as chemistry, fractional excretion of sodium , fractional excretion of urea , beta natriuretic peptide , albumin
5. Radiographic parameters
6. Echocardiographic parameters including Left Ventricular Ejection Fraction (LVEF), Right Ventricular (RV) function and IVC size and variations
7. Mechanical ventilation
8. Daily fluid balance

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.

In spontaneously breathing, non-ventilated patients, we will calculate the IVC collapsibility index (IVC-CI) = \[IVC max-IVC min\]/IVC max.

Whereas in patients who are mechanically ventilated we will calculate their IVC variation index (ΔIVC) = IVC max-IVC min/ IVC mean diameter.

IVC-CI, ΔIVC, IVC size will be used to classify patient as volume responders or non-responder. Prior studies have suggested Intravascular volume depletion is likely present when the, IVC\<1 cm , IVC-CI is \> 50% in spontaneously breathing patients and volume responsiveness when the ΔIVC is ≥ 12% in mechanically ventilated patient .

The Fractional excretion of sodium as well as the fractional excretion of urea (when diuretics are used) will be calculated to classify the etiology of the renal failure as pre-renal or intrinsic renal failure.

Fluid balance as well as the change in plasma Creatinine level at 48 hours post admission will be recorded.

Two groups of patients will be identified:

* Group 1 includes the patients who were managed in concordance with their IVC measurements (Volume responders who had a positive fluid balance at 48 h post admission and volume non responders who had an even or negative fluid balance at 48 hours post admission).
* Group 2 includes the patients in whom the fluid management was discordant with the IVC measurement.

Analyses will be done at 24 as well as 48 hours post admission.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Renal Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Acute renal failure in ICU

Ultrasound for measurement of Inferior Vena Cava size

Ultrasound for measurement of Inferior Vena Cava size.

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ultrasound for measurement of Inferior Vena Cava size.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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)

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Houssein Youness, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 29057120 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

3464

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.