Clinical Trials Directory

Trials / Completed

CompletedNCT01979042

Urinary Markers for Unilateral Kidney Obstruction

Can Modern Urinary Markers be Used as Markers for Acute Kidney Failure Due to Stone Obstruction

Status
Completed
Phase
Study type
Observational
Enrollment
53 (actual)
Sponsor
Carmel Medical Center · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

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. 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: 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

Timeline

Start date
2013-10-01
Primary completion
2015-11-01
Completion
2015-11-01
First posted
2013-11-08
Last updated
2016-10-26

Locations

1 site across 1 country: Israel

Source: ClinicalTrials.gov record NCT01979042. Inclusion in this directory is not an endorsement.