Acute Kidney InjuryNCT02376712
Diagnostic Value of Urinary Indices in Differentiating Pre-renal and Renal Acute Kidney Injury
An observational study of Acute Kidney Injury, run by Peking Union Medical College Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed acute kidney injury at ICU admission or during ICU stay
Who may be able to join
- 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.
Who cannot join
- Obstructive renal disease
- Renal replacement therapy (RRT) for chronic kidney disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
MICU of Peking Union Medical College
Beijing, 100730
Bin Du, Dr, (8610)69155036, dubin98@gmail.com
About this study
The study aims to evaluate the diagnostic value of urinary indices in differentiating pre-renal and renal acute kidney injury among critically ill patients.
Read the 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.
- Conditions
- Acute Kidney Injury
- Keywords
- Acute Kidney Injury, Differential diagnosis, Urinary indices, Renal Blood Flow, Transesophageal Echocardiography
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At ICU admission and during ICU stay
Secondary outcomes (1)
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.
Measured: At ICU admission and during ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Du, Peking Union Medical College Hospital
- Investigators
- Bin Du, Dr, Principal investigator, MICU of Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376712
- Sponsor's protocol ID
- MICU2015-2
- Status last verified
- Feb 2015
- First submitted
- 25 Feb 2015
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Urinary Indices in Differentiating Pre-renal and Renal Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT02376712
- Acronym / sponsor ID
- MICU2015-2
- Conditions
- Acute Kidney Injury
- Keywords
- Acute Kidney Injury, Differential diagnosis, Urinary indices, Renal Blood Flow, Transesophageal Echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- May 2015 (estimated)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed acute kidney injury at ICU admission or during ICU stay
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Obstructive renal disease
- Renal replacement therapy (RRT) for chronic kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Feasibility of measuring renal blood flow among critically ill patients
Time frame: At ICU admission and during ICU stay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bin Du, Dr principal investigator
MICU of Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bin Du, Dr (8610-69155036, dubin98@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic value of urinary indices in differentiating pre-renal and renal AKI (time frame: At ICU admission and during ICU stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2015.