Skip to main content
OpenTrials
Completed

NCT Number: NCT02064244

Inferior Vena Cava (IVC) Size in Acute Renal Failure

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound for measurement of Inferior Vena Cava size.

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.

Primary outcomes

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

    Time frame: 48 hours

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

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

    Time frame: 24 and 48 hours

    glomerular filtration rate (GFR), changes in hemodynamic parameters (mean arterial blood pressure, urine output, pressors requirement) and Partial O2 /Fio2 in group 1 and group 2.

    Different cut off for IVC size measurement and variations will be used to improve the predictive value of the ultrasound in the management of renal failure in hypervolemic patients.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

Does the Inferior Vena Cava Size Assessment Help in the Management of Acute Kidney Injury in Critically Ill Patients?

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 17, 2014
Registry last updated
Jun 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.