Acute Kidney FailureNCT01275729
The Effect of Loop Diuretics on Severity and Outcome of Acute Kidney Injury
A study testing Furosemide in people with Acute Kidney Failure, run by University of Chicago at 4 sites in United States.
Trial summary
The primary objective is to safely determine if the investigators can identify the severity of Acute Kidney Injury (AKI) early in the course of the disease. Once enrolled the investigators will draw blood and urine for novel and standard biomarkers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Failure
- What is being tested?
- Furosemide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2010to Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- 18 yrs or older
- increase in serum creatinine of 0.3 mg/dl within 48 hours or an increase of greater than or equal to 150% from baseline or sustained oliguria (UOP < 0.5 cc/kg/hr for 6 hours with the last 48hours)
- written informed consent
- patients with an indwelling bladder catheter
Who cannot join
- Voluntary refusal
- Patients with advanced chronic kidney disease - as defined by a baseline glomerular filtration rate (GFR) < 30 ml/min (MDRD)
- history of renal transplant
- Pregnant patients
- Allergy / Sensitivity to Loop diuretics (furosemide)
- Pre-renal AKI
Show all 12Show fewer
- defined by a Fractional Excretion of Sodium (FENa) of < 1% and no urinary casts
- under-resuscitated as per the treating clinical team
- active bleed
- Post renal AKI
- evidence of hydro-ureter
- clinical scenario wherein obstruction is considered a likely possibility
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins Medicine
Baltimore, Maryland, 21205
University of Chicago
Chicago, Illinois, 60637
University of California-San Francisco
San Francisco, California, 94143
George Washington University
Washington D.C., District of Columbia, 20037
About this study
The primary objective is to safely determine if the investigators can identify the severity of Acute Kidney Injury (AKI) early in the course of the disease. Once enrolled the investigators will draw blood and urine for novel and standard biomarkers. The investigators are attempting to determine if these biomarkers can forecast the course of AKI (need for dialysis, death and renal recovery). The investigators seek to determine how well physicians caring for those with AKI can predict the clinical course compared to these novel biomarkers of AKI and if there is an association between clinical course and 3 year patient outcomes.
Read the detailed description
AKI is a very common disease in the setting of critical illness and carries an extremely high morbidity and mortality rate (over 50%). Currently there are no FDA approved therapeutic agents for the treatment of AKI. There is limited prospective evidence to guide nephrologists in terms of which patients will progress to more severe AKI in the setting of early AKI. Similarly, there is no evidence to guide nephrologists in terms of which patients will completely recover their renal function after AKI. Thus we need to know very early in the course of AKI which patients will progress and go on to require renal replacement therapy (RRT). Additionally we will investigating the long term patient outcomes, 2-3 years after the index AKI admission.
- Conditions
- Acute Kidney Failure
- Being tested
- Furosemide
- Keywords
- Renal Replacement Therapy, Diuretics, Biomarkers, Renal Insufficiency, Furosemide, Therapeutic Uses, Physiological Effects of Drugs, Biological Markers
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurosemideDrug
Also called Laisx
dose: 1 mg / kg (iv) if the patient is furosemide naive or 1.5 mg/kg (iv) if the patient is not furosemide naive
| Study group | Role | What they receive |
|---|---|---|
| Lasix | Experimental | Pt to get dose of furosemide after meeting entry criteria - dose dependent on previous exposure to diuretics Receives: Drug: Furosemide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression to Stage 3 AKI
The number of patients who progressed to Stage 3 during the time of observation
Measured: within 7 days of furosemide administration
Receipt of Renal Replacement Therapy (RRT)
The number of patients who received renal replacement therapy (Dialysis)
Measured: within 7 days of furosemide administration
Death
Inpatient mortality
Measured: During the index hospital stay, an average of 17 days, until hospital discharge, or until death, whatever occurs first
Secondary outcomes (2)
Length of Intensive Care Unit (ICU) Stay
duration if ICU stay for all patients
Measured: During the index hospital stay, an average of 9 days, until ICU discharge, or until death, whatever occurs first
Length of Hospital Stay
duration of the total hospital Stay for all patients
Measured: During the index hospital stay, an average of 17 days, until hospital discharge, or until death, whatever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionJun 2022
- Study completionJun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Kidney FailureStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jay L Koyner, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275729
- Sponsor's protocol ID
- 10-503-B
- Status last verified
- Jun 2023
- First submitted
- 10 Jan 2011
- Last updated
- 7 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Loop Diuretics on Severity and Outcome of Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT01275729
- Acronym / sponsor ID
- 10-503-B
- Conditions
- Acute Kidney Failure
- Keywords
- Renal Replacement Therapy, Diuretics, Biomarkers, Renal Insufficiency, Furosemide, Therapeutic Uses, Physiological Effects of Drugs, Biological Markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Dec 2010 (actual)
- Primary completion
- Jun 2022 (actual)
- Study completion
- Jun 2022 (actual)
- First posted
- 12 Jan 2011 (estimated)
- Results
- Posted 7 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to safely determine if the investigators can identify the severity of Acute Kidney Injury (AKI) early in the course of the disease. Once enrolled the investigators will draw blood and urine for novel and standard biomarkers. The investigators are attempting to determine if these biomarkers can forecast the course of AKI (need for dialysis, death and renal recovery). The investigators seek to determine how well physicians caring for those with AKI can predict the clinical course compared to these novel biomarkers of AKI and if there is an association between clinical course and 3 year patient outcomes.
Detailed description
AKI is a very common disease in the setting of critical illness and carries an extremely high morbidity and mortality rate (over 50%). Currently there are no FDA approved therapeutic agents for the treatment of AKI. There is limited prospective evidence to guide nephrologists in terms of which patients will progress to more severe AKI in the setting of early AKI. Similarly, there is no evidence to guide nephrologists in terms of which patients will completely recover their renal function after AKI. Thus we need to know very early in the course of AKI which patients will progress and go on to require renal replacement therapy (RRT). Additionally we will investigating the long term patient outcomes, 2-3 years after the index AKI admission.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lasix | Experimental | Drug: FurosemidePt to get dose of furosemide after meeting entry criteria - dose dependent on previous exposure to diuretics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 yrs or older
- increase in serum creatinine of 0.3 mg/dl within 48 hours or an increase of greater than or equal to 150% from baseline or sustained oliguria (UOP < 0.5 cc/kg/hr for 6 hours with the last 48hours)
- written informed consent
- patients with an indwelling bladder catheter
Key exclusion criteria (12 listed)
- Voluntary refusal
- Patients with advanced chronic kidney disease - as defined by a baseline glomerular filtration rate (GFR) < 30 ml/min (MDRD)
- history of renal transplant
- Pregnant patients
- Allergy / Sensitivity to Loop diuretics (furosemide)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FurosemideAlso: Laisxdose: 1 mg / kg (iv) if the patient is furosemide naive or 1.5 mg/kg (iv) if the patient is not furosemide naive | Drug | Lasix |
Primary outcome
Progression to Stage 3 AKI
Time frame: within 7 days of furosemide administration
The number of patients who progressed to Stage 3 during the time of observation
Receipt of Renal Replacement Therapy (RRT)
Time frame: within 7 days of furosemide administration
The number of patients who received renal replacement therapy (Dialysis)
Death
Time frame: During the index hospital stay, an average of 17 days, until hospital discharge, or until death, whatever occurs first
Inpatient mortality
2 secondary outcomes
Length of Intensive Care Unit (ICU) Stay
Time frame: During the index hospital stay, an average of 9 days, until ICU discharge, or until death, whatever occurs first
Length of Hospital Stay
Time frame: During the index hospital stay, an average of 17 days, until hospital discharge, or until death, whatever occurs first
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jay L Koyner, MD principal investigator
University of Chicago
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Furosemide in people with Acute Kidney Failure, run by University of Chicago at 4 sites in United States.
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 12 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: finished, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Yes. Results are posted in the registry (first posted 7 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression to Stage 3 AKI (time frame: within 7 days of furosemide administration). The study lists 3 primary outcomes in all. 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 7 Jul 2023.