Understanding the Urine Electrolyte Profile of the Individual Renal Unit

NCT02837393 | Terminated

• 1 other identifier: IRB00099408
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators objective is to determine if urinary electrolyte abnormalities exist in only one or both kidneys in participants with and without a history of kidney stones. To meet this objective, the investigators are going to take urine samples from each kidney at the time of kidney stone surgery. The samples will then be analyzed for absolute and relative differences in the concentrations of urine electrolytes, such as calcium.

Conditions

Kidney Calculi; Nephrolithiasis; Urolithiasis

Outcome Measures

Primary Outcomes (1)

• Concentrations of urine electrolytes

  The investigators' will determine if there is a difference in urine electrolyte concentrations within individuals between the two kidneys, and across individuals in those with and without a history of kidney stones.

  1 year

Study Arms (2)

History of Kidney Stones

Participants with a history of kidney stones who will be undergoing kidney surgery.

Procedure: Ureteral catheterization

No History of Kidney Stones

Participants without a history of kidney stones who will be undergoing kidney surgery.

Procedure: Ureteral catheterization

Interventions

Ureteral catheterization PROCEDURE

During ureteral catheterization, urine samples will be obtain from each kidney

History of Kidney Stones; No History of Kidney Stones

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be a prospective cohort study conducted within the Department of Urology at Johns Hopkins Hospital and Bayview Medical Center. The study population will be comprised of a convenience sample of participants 18 years of age or older who will be undergoing upper urinary tract surgery as part of routine clinical care for a diagnosis of nephrolithiasis, hematuria, ureteral stricture, ureteropelvic junction obstruction, hydronephrosis, or intra-operative identification of the ureters.

You may qualify if:

• Age ≥18 years of age
• Planed upper urinary tract surgery for a diagnosis of nephrolithiasis, hematuria, ureteral stricture, ureteropelvic junction obstruction, hydronephrosis, or intra-operative identification of the ureters.

You may not qualify if:

• History of an anatomic abnormality of the urinary tract.
• History of a solitary kidney.
• Untreated or a history of lower or upper urinary tract urothelial malignancy.
• Active urinary tract infection.
• Pregnancy.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Kidney Calculi; Nephrolithiasis; Urolithiasis

Interventions

Urinary Catheterization

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Urological; Diagnostic Techniques and Procedures; Diagnosis; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• Justin B Ziemba, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: July 19, 2016
• Study Start: July 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: August 18, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)