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

NCT ID: NCT02376712

Last Updated: 2015-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Acute Kidney Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bin Du

Director of Medical ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bin Du, Dr

Role: PRINCIPAL_INVESTIGATOR

MICU of Peking Union Medical College

Locations

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MICU of Peking Union Medical College

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Bin Du, Dr

Role: CONTACT

8610-69155036

Facility Contacts

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Bin Du, Dr

Role: primary

(8610)69155036

Other Identifiers

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MICU2015-2

Identifier Type: -

Identifier Source: org_study_id

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