Renal ColicNCT01979042
Urinary Markers for Unilateral Kidney Obstruction
An observational study of Renal Colic and Acute Renal Failure, run by Carmel Medical Center at 1 site in Israel.
Trial summary
Renal colic is usually caused from an obstructing stone along the ureter. Some of the patients present with a high level of creatinin in the blood, even though there is a normal functioning contralateral kidney. Furthermore creatinin is not an ideal marker for renal function during acute changes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Colic, Acute Renal Failure
- How many people
- 53 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2013to Nov 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 100 men and women - 80 presented in the ER with a unilateral ureteral stone and 20 presented for ambulatory surgery not related to urinary stones or bladder outlet obstruction
Who may be able to join
- no known kidney disease
- turned to the ER due to renal colic
- imaging demonstrates a partially or totally obstructing ureteral stone
- turned to the urology department for ambulatory surgery: hydrocelectomy, varicocelectomy, stress incontinence repair,circumcision,cystoscopy
Who cannot join
- patients with stones in the contralateral ureter
- patients who underwent renal surgery
- patients who took NSAID's (nonsteroidal antiinflammatory drugs) in the past week before presentation
- patients woth anatomical defects in the kidneys
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Modern Urinary Markers be Used as Markers for Acute Kidney Failure Due to Stone Obstruction
Renal colic is usually caused from an obstructing stone along the ureter. Some of the patients present with a high level of creatinin in the blood, even though there is a normal functioning contralateral kidney. Furthermore creatinin is not an ideal marker for renal function during acute changes.
Several works have shown that modern urinary markers such as NGAL (neutrophil gelatinase-associated lipocalin), KIM-1 (Kidney Injury Molecule-1) and others rise earlier and are much more sensitive for kidney insult. There is a lack of research on their role in acute kidney obstruction
Read the detailed description
The study population will include 100 men and women that will be recruited during the upcoming year, with a follow up of up to 3 months.
The study population will be divided into 2 groups:
- The stone group: about 80 patients, aged 18-65, with normal creatinine for the past year that presented in our ER because of renal colic, and their imaging shows a ureteral stone.
- The non-stone group: about 20 patients that present in our department for elective surgery not related to stones or bladder outlet obstruction.
The stone group:
---------------- In the ER the patients will be examined, undergo blood and urine workup and imaging as usual. If they are applicable according to our inclusion and exclusion criteria and admitted and they will be included in our stone group. After signing an informed consent, either as patients with a ureteral stone and normal creatinine or as patients with a ureteral stone and an abnormal creatinine, Their urine sample will be sent for the urinary markers: NGAL, KIM-1, ENdothelin and Cystatin C.
At this point it will be decided to admit or discharge them according to their clinical imaging and laboratory findings, as acceptable. The admitted patients will be followed for 48 with additional blood and urine tests.
The admitted patients that will undergo renal drainage will be a specific subgroup in which a selective urine test will be taken from the drained kidney
The non stone group:
-------------------- These are our control group from which we will take a single blood and urine test before their elective surgery.
- Conditions
- Renal Colic, Acute Renal Failure
- Keywords
- renal colic, acute renal failure, Neutrophil gelatinase associated lipocalin
- Medical subject headings
- Renal Colic, 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 |
|---|---|---|
| patients with stones | 80 men and women with a normal creatinine for the past year that present in the ER with renal colic and a stone in their ureter according to imaging | |
| patients without stones | 20 men and women that presented in our department for elective surgery that is not related to stones or bladder outlet obstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary markers behavior
What is the level of the urine markers NGAL, KIM-1, ENdothelin and Cystatin C at presentation and 48 hours after presentation, in patients presenting with renal colic in the ER
Measured: one week
Secondary outcomes (1)
following the markers in patients whose kidneys were drained
What is the level of the urine markers NGAL, KIM-1, ENdothelin and Cystatin C at presentation and after 48 hours after presentation, in patients with renal colic whose kidneys were drained by a ureteral stent
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ColicStudies of the same condition, open and under way.
- 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ilan B Klein, MD, Principal investigator, Carmel Medical CenterAvi Stein, Prof., Study director, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979042
- Sponsor's protocol ID
- CMC-12-0150-CTIL
- Status last verified
- Oct 2016
- First submitted
- 21 Oct 2013
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Modern Urinary Markers be Used as Markers for Acute Kidney Failure Due to Stone Obstruction
- ClinicalTrials.gov ID
- NCT01979042
- Acronym / sponsor ID
- CMC-12-0150-CTIL
- Conditions
- Renal Colic, Acute Renal Failure
- Keywords
- renal colic, acute renal failure, Neutrophil gelatinase associated lipocalin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 8 Nov 2013 (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.
Renal colic is usually caused from an obstructing stone along the ureter. Some of the patients present with a high level of creatinin in the blood, even though there is a normal functioning contralateral kidney. Furthermore creatinin is not an ideal marker for renal function during acute changes.
Several works have shown that modern urinary markers such as NGAL (neutrophil gelatinase-associated lipocalin), KIM-1 (Kidney Injury Molecule-1) and others rise earlier and are much more sensitive for kidney insult. There is a lack of research on their role in acute kidney obstruction
Detailed description
The study population will include 100 men and women that will be recruited during the upcoming year, with a follow up of up to 3 months.
The study population will be divided into 2 groups:
- The stone group: about 80 patients, aged 18-65, with normal creatinine for the past year that presented in our ER because of renal colic, and their imaging shows a ureteral stone.
- The non-stone group: about 20 patients that present in our department for elective surgery not related to stones or bladder outlet obstruction.
The stone group:
---------------- In the ER the patients will be examined, undergo blood and urine workup and imaging as usual. If they are applicable according to our inclusion and exclusion criteria and admitted and they will be included in our stone group. After signing an informed consent, either as patients with a ureteral stone and normal creatinine or as patients with a ureteral stone and an abnormal creatinine, Their urine sample will be sent for the urinary markers: NGAL, KIM-1, ENdothelin and Cystatin C.
At this point it will be decided to admit or discharge them according to their clinical imaging and laboratory findings, as acceptable. The admitted patients will be followed for 48 with additional blood and urine tests.
The admitted patients that will undergo renal drainage will be a specific subgroup in which a selective urine test will be taken from the drained kidney
The non stone group:
-------------------- These are our control group from which we will take a single blood and urine test before their elective surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with stones | – | –80 men and women with a normal creatinine for the past year that present in the ER with renal colic and a stone in their ureter according to imaging |
| patients without stones | – | –20 men and women that presented in our department for elective surgery that is not related to stones or bladder outlet obstruction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 100 men and women - 80 presented in the ER with a unilateral ureteral stone and 20 presented for ambulatory surgery not related to urinary stones or bladder outlet obstruction
Key inclusion criteria (4 listed)
- no known kidney disease
- turned to the ER due to renal colic
- imaging demonstrates a partially or totally obstructing ureteral stone
- turned to the urology department for ambulatory surgery: hydrocelectomy, varicocelectomy, stress incontinence repair,circumcision,cystoscopy
Key exclusion criteria (4 listed)
- patients with stones in the contralateral ureter
- patients who underwent renal surgery
- patients who took NSAID's (nonsteroidal antiinflammatory drugs) in the past week before presentation
- patients woth anatomical defects in the kidneys
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
urinary markers behavior
Time frame: one week
What is the level of the urine markers NGAL, KIM-1, ENdothelin and Cystatin C at presentation and 48 hours after presentation, in patients presenting with renal colic in the ER
1 secondary outcome
following the markers in patients whose kidneys were drained
Time frame: one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
Related trials for Renal Colic
Not yet recruitingPhase 3
Comparative Efficacy of IV Dexamethasone vs. Nebulized Terbutaline for Renal Colic Pain in the ED
Renal Colic
Not yet recruiting
Relief Efficacy of Lidocaine Versus Morphine for Acute Renal Colic in the Emergency Department
Renal Colic, Kidney Stones, Urolithiasis, Hypocitraturia
Recruiting
Ear Pressure Points Plus Pain Meds for Faster Kidney Stone Pain Relief
Renal Colic, Acupuncture, Ear
Active, not recruiting
Sterile Water Injection vs Morphine for Renal Colic
Renal Colic, Urolithiasis
Not yet recruitingPhase 4
Analgesic Efficacy of Transcutaneous Electrical Nerve Stimulation and Dexketoprofen in Renal Colic
Renal Colic
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.
Ilan B Klein, MD principal investigator
Carmel Medical Center
Avi Stein, Prof. study director
Carmel Medical Center
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 Renal Colic and Acute Renal Failure, run by Carmel Medical Center at 1 site in Israel.
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 4 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 26 Oct 2016. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
urinary markers behavior (time frame: one week). 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 26 Oct 2016.