Trial record 15 of 26 for:    Open Studies | "Colic"

Urinary Markers for Unilateral Kidney Obstruction

This study is currently recruiting participants.
Verified November 2013 by Carmel Medical Center
Sponsor:
Information provided by (Responsible Party):
Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01979042
First received: October 21, 2013
Last updated: November 3, 2013
Last verified: November 2013
  Purpose

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
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 ] [ Designated as safety issue: No ]
    What is the level of the urine markers NGAL, KIM-1, ENdothelin and Cystatin C at presentation, after 48 hours and one week 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 ] [ Designated as safety issue: No ]
    What is the level of the urine markers NGAL, KIM-1, ENdothelin and Cystatin C at presentation, after 48 hours and one week after presentation, in patients with renal colic whose kidneys were drained by a ureteral stent


Biospecimen Retention:   Samples Without DNA

urine


Estimated Enrollment: 100
Study Start Date: October 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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 after signing an informed consent, they will be included in our stone group, 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. They will be followed 48 hours and 1 one week later 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01979042

Contacts
Contact: Ilan B Klein, MD 972526332547 ilankl@clalit.org.il
Contact: Avi Stein, Prof. 97248250843 avist@clalit.org.il

Locations
Israel
Carmel Lady Davis Medical Center Recruiting
Haifa, Israel
Contact: Ilan B Klein, MD    972526332547    ilankl@clalit.org.il   
Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: Ilan B Klein, MD Carmel Medical Center
Study Director: Avi Stein, Prof. Carmel Medical Center
  More Information

No publications provided

Responsible Party: Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01979042     History of Changes
Other Study ID Numbers: CMC-12-0150-CTIL
Study First Received: October 21, 2013
Last Updated: November 3, 2013
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Renal Colic
Colic
Kidney Diseases
Urologic Diseases
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on April 20, 2014