Urinary Markers for Unilateral Kidney Obstruction
|ClinicalTrials.gov Identifier: NCT01979042|
Recruitment Status : Completed
First Posted : November 8, 2013
Last Update Posted : October 26, 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
|Condition or disease|
|Renal Colic Acute Renal Failure|
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 Type :||Observational|
|Actual Enrollment :||53 participants|
|Official Title:||Can Modern Urinary Markers be Used as Markers for Acute Kidney Failure Due to Stone Obstruction|
|Study Start Date :||October 2013|
|Primary Completion Date :||November 2015|
|Study Completion Date :||November 2015|
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
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01979042
|Carmel Lady Davis Medical Center|
|Principal Investigator:||Ilan B Klein, MD||Carmel Medical Center|
|Study Director:||Avi Stein, Prof.||Carmel Medical Center|