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

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status

Unknown

Conditions

Acute Kidney Injury

Study type

Observational

Funder types

Other

Identifiers

NCT02376712
MICU2015-2

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Pre-renal AKI
Description:
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
Description:
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.

Trial contacts and locations

1

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Central trial contact

Bin Du, Dr

Data sourced from clinicaltrials.gov

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