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Clinical Trials/NCT02064244
NCT02064244
Completed
Not Applicable

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

University of Oklahoma1 site in 1 country33 target enrollmentFebruary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Renal Failure
Sponsor
University of Oklahoma
Enrollment
33
Locations
1
Primary Endpoint
percentage of patients with improved Creatinine level in group 1 and 2
Status
Completed
Last Updated
9 years ago

Overview

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

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: 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.

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
May 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • 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 Sites (1)

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