Urinary Markers for Unilateral Kidney Obstruction

Acute Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01979042
• Other study ID #: CMC-12-0150-CTIL
• Status: Completed
• Phase: N/A
• First received: October 21, 2013
• Last updated: October 25, 2016
• Start date: October 2013
• Est. completion date: November 2015

Study information

• Verified date: October 2016
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Renal Colic
• Renal Insufficiency

Locations

Country	Name	City	State
Israel	Carmel Lady Davis Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urinary markers behavior	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	one week	No
Secondary	following the markers in patients whose kidneys were drained	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	one week	No