Diagnostic Value of Urinary Indices in Differentiating Pre-renal and Renal Acute Kidney Injury
1 other identifier
observational
40
1 country
1
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.
Trial Health
Trial Health Score
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participants targeted
Target at P25-P50 for all trials
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 25, 2015
CompletedFirst Posted
Study publicly available on registry
March 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedMarch 3, 2015
February 1, 2015
4 months
February 25, 2015
March 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic value of urinary indices in differentiating pre-renal and renal AKI
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.
At ICU admission and during ICU stay
Secondary Outcomes (1)
Feasibility of measuring renal blood flow among critically ill patients
At ICU admission and during ICU stay
Other Outcomes (2)
Diagnostic value of urinary indices in the subgroup of patients without diuretic use
At ICU admission and during ICU stay
Diagnostic value of urinary indices in the subgroup of patients without sepsis
At ICU admission and during ICU stay
Study Arms (2)
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.
Eligibility Criteria
Patients diagnosed acute kidney injury at ICU admission or during ICU stay
You may qualify if:
- 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.
You may not qualify if:
- Obstructive renal disease
- Renal replacement therapy (RRT) for chronic kidney disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MICU of Peking Union Medical College
Beijing, 100730, China
Biospecimen
Serum, urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bin Du, Dr
MICU of Peking Union Medical College
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Medical ICU
Study Record Dates
First Submitted
February 25, 2015
First Posted
March 3, 2015
Study Start
January 1, 2015
Primary Completion
May 1, 2015
Last Updated
March 3, 2015
Record last verified: 2015-02