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

Acute Kidney Injury Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02376712
• Other study ID #: MICU2015-2
• Status: Recruiting
• Phase: N/A
• First received: February 25, 2015
• Last updated: March 2, 2015
• Start date: January 2015

Study information

• Verified date: February 2015
• Source: Peking Union Medical College Hospital
• Contact: Bin Du, Dr
• Phone: 8610-69155036
• Email: dubin98[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury

Locations

Country	Name	City	State
China	MICU of Peking Union Medical College	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diagnostic value of urinary indices in the subgroup of patients without diuretic use	The same strategy as the primary outcome will be used in subgroup of patients without diuretic use.	At ICU admission and during ICU stay	No
Other	Diagnostic value of urinary indices in the subgroup of patients without sepsis	The same strategy as the primary outcome will be used in subgroup of patients without sepsis.	At ICU admission and during ICU stay	No
Primary	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	No
Secondary	Feasibility of measuring renal blood flow among critically ill patients	Feasibility includes rate of success of measurement, intra-observer variability, inter-observer variability, and intraclass correlation coefficients.	At ICU admission and during ICU stay	No