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Urinary Markers for Unilateral Kidney Obstruction

This study has been completed.
Information provided by (Responsible Party):
Carmel Medical Center Identifier:
First received: October 21, 2013
Last updated: October 25, 2016
Last verified: October 2016

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

Renal Colic
Acute Renal Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Can Modern Urinary Markers be Used as Markers for Acute Kidney Failure Due to Stone Obstruction

Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • following the markers in patients whose kidneys were drained [ Time Frame: one week ]
    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

Biospecimen Retention:   Samples Without DNA

Enrollment: 53
Study Start Date: October 2013
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
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

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:

  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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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

Inclusion Criteria for stone group:

  • no known kidney disease
  • turned to the ER due to renal colic
  • imaging demonstrates a partially or totally obstructing ureteral stone

Inclusion Criteria for non stone group:

  • turned to the urology department for ambulatory surgery: hydrocelectomy, varicocelectomy, stress incontinence repair,circumcision,cystoscopy

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01979042

Carmel Lady Davis Medical Center
Haifa, Israel
Sponsors and Collaborators
Carmel Medical Center
Principal Investigator: Ilan B Klein, MD Carmel Medical Center
Study Director: Avi Stein, Prof. Carmel Medical Center
  More Information

Responsible Party: Carmel Medical Center Identifier: NCT01979042     History of Changes
Other Study ID Numbers: CMC-12-0150-CTIL
Study First Received: October 21, 2013
Last Updated: October 25, 2016

Keywords provided by Carmel Medical Center:
renal colic
acute renal failure
Neutrophil gelatinase associated lipocalin

Additional relevant MeSH terms:
Renal Insufficiency
Acute Kidney Injury
Renal Colic
Kidney Diseases
Urologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on May 23, 2017