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Diagnostic Value of Urinary Indices in Differentiating Pre-renal and Renal Acute Kidney Injury

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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
Sponsor:
Information provided by (Responsible Party):
Bin Du, Peking Union Medical College Hospital

Brief Summary:
The study aims to evaluate the diagnostic value of urinary indices in differentiating pre-renal and renal acute kidney injury among critically ill patients.

Condition or disease
Acute Kidney Injury

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : January 2015
Estimated Primary Completion Date : May 2015

Group/Cohort
Pre-renal AKI

Three definitions of pre-renal AKI will be used separately:

  1. Hemodynamic instability (any sign of tissue hypoperfusion) on AKI identification, and AKI recovery in 24-72 hours following hemodynamic stabilization.
  2. AKI recovery in less than 72 hours after AKI identification.
  3. Decreased renal blood flow measured by transesophageal echocardiography (TEE).
Renal AKI

Three definitions of renal AKI will be used separately:

  1. Hemodynamically stable at AKI identification; or hemodynamically instability (any sign of tissue hypoperfusion) on AKI identification, and AKI persistence in 24-72 hours following hemodynamic stabilization.
  2. AKI persistence 72 hours after AKI identification.
  3. Normal or increased renal blood flow measured by TEE.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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
Serum, urine


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed acute kidney injury at ICU admission or during ICU stay
Criteria

Inclusion Criteria:

All patients admitted to Medical ICU of PUMCH with one of the following:

  • Increase in serum creatinine by ≥ 26.5 umol/l within 48 hours;
  • Increase in serum creatinine to ≥ 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days;
  • Urine volume < 0.5ml/kg/h for 1 hour.

Exclusion Criteria:

  • Obstructive renal disease
  • Renal replacement therapy (RRT) for chronic kidney disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376712


Contacts
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Contact: Bin Du, Dr 8610-69155036 dubin98@gmail.com

Locations
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China
MICU of Peking Union Medical College Recruiting
Beijing, China, 100730
Contact: Bin Du, Dr    (8610)69155036    dubin98@gmail.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Bin Du, Dr MICU of Peking Union Medical College
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Responsible Party: Bin Du, Director of Medical ICU, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02376712    
Other Study ID Numbers: MICU2015-2
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: February 2015
Keywords provided by Bin Du, Peking Union Medical College Hospital:
Acute Kidney Injury
Differential diagnosis
Urinary indices
Renal Blood Flow
Transesophageal Echocardiography
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases