Diagnostic Value of Urinary Indices in Differentiating Pre-renal and Renal Acute Kidney Injury
|ClinicalTrials.gov Identifier: NCT02376712|
Recruitment Status : Unknown
Verified February 2015 by Bin Du, Peking Union Medical College Hospital.
Recruitment status was: Recruiting
First Posted : March 3, 2015
Last Update Posted : March 3, 2015
|Condition or disease|
|Acute Kidney Injury|
Critically ill patients with acute kidney injury (AKI) will be included. Urinary indices will be obtained immediately after defining AKI, including specific gravity (SG), urine osmolarity (Uosm), urine sodium (UNa), fractional excretion of sodium (FENa), and fractional excretion of urea (FEurea).
The patterns of renal function and hemodynamic status serve as the clinical definition of pre-renal and renal AKI. Hemodynamic status will be evaluated at inclusion and followed during patients' ICU stay. Those who are hemodynamically stable at inclusion are classified as renal AKI. Those who are hemodynamically unstable at inclusion are followed until hemodynamic stabilization. Those with AKI recovery after hemodynamic stabilization are classified as pre-renal AKI. Those without AKI recovery are defined as renal AKI.
Urinary indices are measured again after hemodynamic stability. One of the investigators objectives is to evaluate the diagnostic value of urinary indices using recovery of renal function after hemodynamic stabilization as the definition of pre-renal AKI.
Transesophageal echocardiography (TEE) has been proved to be a reliable method of measuring left renal blood flow during surgical operation. Decreased renal blood flow measured by TEE may serve as an objective definition of pre-renal AKI. The mesurement will be conducted at inclusion if the patient is sedated, intubated, and without TEE contraindication. If the patient is hemodynamically unstable at inclusion, the measurement will be repeated after hemodynamic stabilization. The investigators study also serves the following aims: (1) feasibility of measuring renal blood flow by TEE among critically ill patients; (2) the correspondence between renal blood flow measured by TEE and clinical definition of pre-renal and renal AKI; (3) the diagnostic value of urinary indices in differentiating pre-renal and renal AKI, which is judged by renal blood flow measured by TEE.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||May 2015|
Three definitions of pre-renal AKI will be used separately:
Three definitions of renal AKI will be used separately:
- Diagnostic value of urinary indices in differentiating pre-renal and renal AKI [ Time Frame: At ICU admission and during ICU stay ]Urinary indices will be compared between patient groups (pre-renal and renal AKI). Sensitivity analysis will be applied to the cut off values of renal blood flow measured by TEE. Sensitivity and specificity of the indices will be calculated. Receiver operating characteristic curves will be plotted.
- Feasibility of measuring renal blood flow among critically ill patients [ Time Frame: At ICU admission and during ICU stay ]Feasibility includes rate of success of measurement, intra-observer variability, inter-observer variability, and intraclass correlation coefficients.
- Diagnostic value of urinary indices in the subgroup of patients without diuretic use [ Time Frame: At ICU admission and during ICU stay ]The same strategy as the primary outcome will be used in subgroup of patients without diuretic use.
- Diagnostic value of urinary indices in the subgroup of patients without sepsis [ Time Frame: At ICU admission and during ICU stay ]The same strategy as the primary outcome will be used in subgroup of patients without sepsis.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376712
|Contact: Bin Du, Dremail@example.com|
|MICU of Peking Union Medical College||Recruiting|
|Beijing, China, 100730|
|Contact: Bin Du, Dr (8610)69155036 firstname.lastname@example.org|
|Principal Investigator:||Bin Du, Dr||MICU of Peking Union Medical College|