Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
53 participants
OBSERVATIONAL
2013-10-31
2015-11-30
Brief Summary
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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
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The study population will be divided into 2 groups:
1. 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.
2. 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
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Carmel Medical Center
OTHER
Responsible Party
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Principal Investigators
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Ilan B Klein, MD
Role: PRINCIPAL_INVESTIGATOR
Carmel Medical Center
Avi Stein, Prof.
Role: STUDY_DIRECTOR
Carmel Medical Center
Locations
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Carmel Lady Davis Medical Center
Haifa, , Israel
Countries
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Other Identifiers
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CMC-12-0150-CTIL
Identifier Type: -
Identifier Source: org_study_id