Renogram Study With Percutaneous Nephrolithotomy (PERC): Alterations in Renal Blood Flow as a Consequence of PERC

NCT00169741 | Completed

• 1 other identifier: 05-043
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with large or otherwise complex renal calculi are commonly treated by percutaneous nephrolithotomy (PNL; PERC). PERC requires the creation of an approximately 10 mm channel through the renal parenchyma, into the intra-renal collecting system, in order to effect stone fragmentation and extraction. Although the nephrostomy tract is confined to a small fraction of the renal parenchyma (approximately 1%), the trauma associated with the creation of the tract will affect blood flow and oxygen delivery to regions beyond the immediate site of injury. It is possible that this could result in a significant functional renal impairment. There are several reports describing the effect of PERC on renal function, but interpretation of these studies is difficult, due to a lack of uniformity in patient selection and variability in the timing of peri-operative evaluation. Recent data from the investigators' lab, obtained from a porcine model, suggest that, acutely, PERC causes a significant decrease in renal function as measured by para amino hippurate (PAH) clearance. The purpose of this study is to determine, in a rigorous and standardized fashion, the acute effects of PERC on renal function, as measured by nuclear renography.

Conditions

Renal Calculi

Keywords

Nephrolithiasis; Renal Calculi

Outcome Measures

Primary Outcomes (1)

• The hypothesis is that the effects of PERC anticipated on renal function will be largely resolved and the 6 week post-procedure study will not be significantly different from the pre-operative study.

  One year after study completion

Study Arms (1)

cohort

OTHER

Other: Renogram

Interventions

Renogram OTHER

Subjects who enroll in this study will undergo a nuclear scan called a renogram to assess renal function prior to surgery (baseline), approximately one hour after surgery (to assess percutaneous effects on renal function) and finally approximately 6 weeks post-operatively (to assess return to baseline).

cohort

Eligibility Criteria

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

You may qualify if:

• Patients of Methodist Urology in Indianapolis, IN
• Age greater than 18 years
• Ability to provide informed consent
• Unilateral renal calculi appropriate for percutaneous removal

You may not qualify if:

• Age less than 18
• Inability to give informed consent
• Pregnant
• Renal calculi associated with infection
• Serum creatinine \> 1.4 mg/dL
• Renal obstruction
• Renal anatomic abnormality precluding accurate functional assessment using nuclear medicine techniques
• Renal duplication/anatomic abnormality (e.g., horseshoe kidney, malrotation, ectopia, etc.)
• Pre-existing diuretic therapy
• Solitary functional kidney or suspected significant differential in renal function
• Presence of diabetes, hypertension, or any other systemic disorder or medication known to affect renal function
• History of urinary tract infection

Sponsors & Collaborators

• Indiana Kidney Stone Institute: lead

Study Sites (1)

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Kidney Calculi; Nephrolithiasis

Condition Hierarchy (Ancestors)

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

Study Officials

• James E Lingeman, MD

  IU Health Physicians Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: May 1, 2005
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 23, 2016

Record last verified: 2016-02

Locations

US (1)