Inferior Vena Cava (IVC) Size in Acute Renal Failure

Sponsor

University of Oklahoma (Other)

Overall Status

Completed

CT.gov ID

NCT02064244

Collaborator

(none)

Enrollment

Location

26.9

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Acute Renal Failure	Other: Ultrasound for measurement of Inferior Vena Cava size.

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

33 participants

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Acute renal failure in ICU Ultrasound for measurement of Inferior Vena Cava size	Other: 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.

Arm

Intervention/Treatment

Acute renal failure in ICU

Ultrasound for measurement of Inferior Vena Cava size

Other: 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.

Outcome Measures

Primary Outcome Measures

percentage of patients with improved Creatinine level in group 1 and 2 [48 hours]
percentage of patients with improved Creatinine level in group 1 and 2

Secondary Outcome Measures

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]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)