Clinical Trials for Kidney Stones

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LLPLUV
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Date Joined Mar 2009
Total Posts : 1158
   Posted 6/28/2009 11:09 AM (GMT -7)   
Once again I will research Kidney Stones for all of you too look at.....
 
If you need further information on any clinical study please email me and I will forward you the information.
 
Most of these studies are still enrolling new patients.
 
Laurie
 
PS Some of this information is confusing and detailed on kidney stones.  I tried to find more patient friendly information like I found for PKD but with no luck..


39 yr young female with,
Chronic Kidney Stones, PKD (Polycystic Kidney Disease), Chronic Kidney Failure, Severe Hypertension, Urological RSD
Also CHF (Congestive Heart Failure) and Sleep Apnea
Hopefully NO MORE........ I think I have it all

Post Edited (LLPLUV) : 6/28/2009 12:54:28 PM (GMT-6)


LLPLUV
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Date Joined Mar 2009
Total Posts : 1158
   Posted 6/28/2009 11:12 AM (GMT -7)   

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

Purpose:
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.

Detailed Description:
PERC is a commonly used technique to treat patients harboring large or complex renal calculi. PERC is a particularly effective procedure, and has been associated with few complications. However, the effect PERC has on renal functional parameters is not well defined.

The effect of PERC on renal function has been examined in an animal model by several groups. In one porcine model, the baseline renal function, as defined by PAH and creatinine clearance, was compared to that measured at one month post-procedure. No acute data were recorded, but the authors did note that although there was no significant change in renal function at the one month follow-up point, there was a significant amount of renal scarring present. This finding of significant renal scarring following PERC in an animal model has been corroborated by others. One group has studied a canine model, and detected a significant diminution of renal function (defined by creatinine clearance) at 48 hours following PERC, and at 6 weeks following PERC renal function returned to normal. In human subjects undergoing PERC, percutaneous tracts have also been associated with renal scarring. These studies, both retrospective case series, did not capture strictly defined measures of renal function, such as creatinine clearance, but rather compared pre- and post-procedure serum creatinine as a surrogate for renal function. No significant change in serum creatinine was identified in either study, but blood collections were performed at variable times, in uncontrolled settings.

Nuclear renography is an imaging technique that records renal functional parameters. There has been only one report of nuclear renographic assessment of the effect of PERC on renal function. This report was an uncontrolled study, and the renograms were performed at a median of 22 days post-procedure. At this time interval, it is not possible to derive any conclusions regarding the acute effects of PERC on renal function.

The investigators have recently demonstrated in a porcine model that PERC is associated acutely with significant deleterious effects on renal function.

Following routine PERC, glomerular filtration rate (GFR) and renal plasma flow (RPF) decline by 50% in both the treated and the untreated kidney and return to normal when measured at 72 & 74 hours (n=3 pigs). Sodium excretion, however, was markedly below baseline at 72 and 74 hours in 2 of the 3 pigs. PAH extraction, a measure of the efficiency of renal tubular secretion of organic anions, averaged 43.5 ± 9.7% and 42.6 ± 14.1% at 72 and 74 hours for the 3 pigs. These values are substantially below the baseline value of 80.4 ± 4.0% measured in sham-PNL pigs.

To date, the examination of the effect of PERC on renal function has been restricted to gross measures of function as defined by serum creatinine, and radionuclide studies performed at a sub-acute interval following PNL, often without differential measurements or controls. Importantly, the investigators' recent studies in a porcine model demonstrate that PERC may cause significant alterations in renal function. There is a need to define in a rigorous fashion the effect PERC has on renal blood flow and renal function. If a deleterious effect is identified, future efforts can be focused on minimizing this insult.


39 yr young female with,
Chronic Kidney Stones, PKD (Polycystic Kidney Disease), Chronic Kidney Failure, Severe Hypertension, Urological RSD
Also CHF (Congestive Heart Failure) and Sleep Apnea
Hopefully NO MORE........ I think I have it all

Post Edited (LLPLUV) : 6/28/2009 12:17:19 PM (GMT-6)


LLPLUV
Veteran Member


Date Joined Mar 2009
Total Posts : 1158
   Posted 6/28/2009 11:14 AM (GMT -7)   
Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis
 
Purpose
Kidney stones are very common. They affect 3-5% of the population in the United States. Many people are hospitalized for the treatment of kidney stones and some may die. Better understanding of what causes kidney stones is useful in both the treatment and prevention of kidney stones. However, exactly what causes kidney stones is unknown.

The most common type of kidney stones contains calcium, which sometimes is attached to a part of the kidney important in producing the final urine, called the papilla. The investigators have noticed that persons who form kidney stones seem to have more papilla with stones attached. They propose to study these areas of the papilla, called Randall's plaques (named after their discoverer), in patients undergoing surgery for kidney stones.

Nephrocalcinosis
Renal Calculi
Hypercalciuria
Hyperparathyroidism
Cystinuria
Other: videotape for mapping of renal anatomy and papillary biopsy


Primary Outcome Measures:
To find out why people form stones by comparing 24 urine collections, biopsy and anatomy to other patients who do not form stones and other patients who do form stones to see if the differences are significant [ Time Frame: One year from study completion ] [ Designated as safety issue: No ]

Detailed Description:
In order to attempt to explain the pathogenesis of renal calculi, the investigators videotape and document the location and characteristics of each stone, papillae and calyces. One or more small papillary biopsies are taken for analysis to help determine the point of origin of the kidney stone and histological studies are undertaken to determine tissue differences amongst different types of stone formers. Approximately one month after surgery, metabolic studies are undertaken to further review potential causes of stone formation.


39 yr young female with,
Chronic Kidney Stones, PKD (Polycystic Kidney Disease), Chronic Kidney Failure, Severe Hypertension, Urological RSD
Also CHF (Congestive Heart Failure) and Sleep Apnea
Hopefully NO MORE........ I think I have it all

Post Edited (LLPLUV) : 6/28/2009 12:18:14 PM (GMT-6)


LLPLUV
Veteran Member


Date Joined Mar 2009
Total Posts : 1158
   Posted 6/28/2009 11:33 AM (GMT -7)   
Ureteral Stent Length and Patient Symptoms

Purpose
The Study of whether or not Ureteral Stent Length affects patient comfort after electro-shock wave treatment for kidney stones.



Condition Intervention
Kidney Stones
Device: Ureteral Stent

Detailed Description:
Patients undergoing electro shock wave for treatment of kidney stones are randomized to long or short stent length after signing an informed consent prior to their surgery. They keep a pain diary and medication diary for a two week period after the stent is placed. These are turned in at the two week post-op visit. Patients also complete a quality of life and urinary symptom score questionnaire pre and post operatively.
39 yr young female with,
Chronic Kidney Stones, PKD (Polycystic Kidney Disease), Chronic Kidney Failure, Severe Hypertension, Urological RSD
Also CHF (Congestive Heart Failure) and Sleep Apnea
Hopefully NO MORE........ I think I have it all


LLPLUV
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Date Joined Mar 2009
Total Posts : 1158
   Posted 6/28/2009 11:39 AM (GMT -7)   
FloSeal Tubeless Exit Versus Cope Loop Nephrostomy Versus Fascial Stitch Following Percutaneous Nephrolithotripsy
Purpose
The patient will be asked to participate in a research project designed to determine the best way to prevent bleeding and promote patient comfort after having kidney stones removed. Two standard methods for ending the surgery are being compared to a newer method. In one standard method, the patient will have a tube draining urine from the kidney after the procedure. This tube may also prevent bleeding from the kidney. In another standard method the patient will have a tube left internally that drains urine from the kidney to the bladder and a stitch will be used to close the incision and deeper tissues in the back. In the third potential option, a tube would be left internally to drain urine from the kidney to the patient's bladder and the surgical site would be filled with a clot promoting agent (FloSeal) which is a FDA approved agent specifically formulated to stop bleeding during surgical procedures.

LLPLUV
Veteran Member


Date Joined Mar 2009
Total Posts : 1158
   Posted 6/28/2009 11:41 AM (GMT -7)   
Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation
Purpose
Ureteral stent placement is one of the most common procedures performed within urology. The stents are generally placed for relief of obstruction or to prevent obstruction following a urological procedure. Most patients with ureteral stents will eventually form stent encrustations. However, patients form these encrustations at dramatically different degrees and rates ranging from no encrustation at 1 year of stenting to severe encrustation in just a few weeks. The purpose of this study is to determine if the degree of encrustation on a stent for any given patient can be predicted based on 24 hour urine parameters prior to stent placement, with the stent in place and after stent removal.

Patients who will be receiving stents for other urological reasons will have a 24 hour urine sample collected before stent placement, while the stent is in place and after the stent has been removed. The parameters examined in the 24 hour urine collected will then be compared to the amount of encrustation there is on the stent to see if there is any correlation between the two.

LLPLUV
Veteran Member


Date Joined Mar 2009
Total Posts : 1158
   Posted 6/28/2009 11:43 AM (GMT -7)   
A Randomized Study of Whether Alfuzosin(Xatral) Helps in the Passage of Kidney Stones
Purpose
Patients who present for the first time to Emergency Room with renal colic due to a distal ureteral calculus (as diagnosed with spiral CT scan and KUB) will be randomized to receive Xatral 10mg po once a day or placebo once discharged from the ER. The purpose of this study is to assess if patients treated with Xatral will have a higher spontaneous passage rate of their ureteral stone than those treated with placebo.

LLPLUV
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Date Joined Mar 2009
Total Posts : 1158
   Posted 6/28/2009 11:48 AM (GMT -7)   
Alfuzosin for Medical Expulsion Therapy of Ureteral Stones (MET)

Purpose


The goal of this study is to conduct a prospective controlled trail of four currently approved Department of Defense (DOD) - formulary medications for use as medical expulsion therapy (MET) for kidney stones. Between 8% and 15% of Americans will develop symptomatic urolithiasis in there life. Several medications, including steroids, calcium channel blockers, alpha-adrenergic antagonists and non-steroidal anti-inflammatory drugs, have been utilized to aid in the spontaneous passage of distal ureteral calculi. Recently, use of selective alpha-blockers has shown promise for medical expulsion therapy (MET) of distal ureteral calculi. None of these studies have been widely publicized outside the specialty of urology. Recent studies have shown a success rate of nearly 90% when the selective alpha-blocker tamsulosin (Flomax) was used for MET. MET has also been shown to result in a decreased narcotic requirement, shorter time to stone passage, and reduced requirement for further interventions. The investigators will evaluate the effectiveness of MET as initial management for kidney stones using DOD-approved formulary medications.

LLPLUV
Veteran Member


Date Joined Mar 2009
Total Posts : 1158
   Posted 6/28/2009 11:50 AM (GMT -7)   
Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy


Purpose

The purpose of this study is to determine whether continuous intravenous ketorolac infusion reduces pain in patients who are having percutaneous nephrolithotomy for kidney stone disease.

LLPLUV
Veteran Member


Date Joined Mar 2009
Total Posts : 1158
   Posted 6/28/2009 11:53 AM (GMT -7)   
Pharmacokinetic, Safety and Efficacy Study of OMS201 in Subjects Undergoing Retrograde Ureteroscopic Removal of Upper Urinary Tract Stones

Purpose


The objectives of the study are to assess the systemic exposure, safety and efficacy of three concentrations of OMS201 in subjects undergoing retrograde ureteroscopic removal of upper urinary tract stones.

LLPLUV
Veteran Member


Date Joined Mar 2009
Total Posts : 1158
   Posted 6/28/2009 11:57 AM (GMT -7)   
Use of Antiretropulsion Device in Laser Lithotripsy

Purpose
The objectives of this post-market evaluation are

to assess the capacity of the procedure to be completed with use of only a semi-rigid ureteroscope, without requiring use of a flexible ureteroscope
to compare the rate of retropulsion and the time required to complete the lithotripsy in patients in which the Accordion device is used in contrast to when such a device is not employed.

LLPLUV
Veteran Member


Date Joined Mar 2009
Total Posts : 1158
   Posted 6/28/2009 12:00 PM (GMT -7)   
Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy

Purpose

The investigators main hypothesis is that the stone free rate will be much higher (95%) in patients treated with PCNL than patients treated with ESWL where stone free rate is (60%) to determine which treatment is safe and prevent less stone recurrence.

LLPLUV
Veteran Member


Date Joined Mar 2009
Total Posts : 1158
   Posted 6/28/2009 12:02 PM (GMT -7)   
International Registry for Primary Hyperoxaluria

Purpose


The purpose of this study is to collect medical information from a large number of patients in many areas of the world with primary hyperoxaluria. This medical information will be entered into a registry to help the investigators compare similarities and differences in patients and their symptoms. The more patients that the investigators are able to enter into the registry, the more the investigators will be able to understand primary hyperoxaluria and learn better ways of treating patients with this disease. It is the investigators hope that by entering as many patients with PH as possible, the information that the investigators collect may help physicians diagnose patients sooner and determine what treatments may work best on patients with similar medical or genetic backgrounds.

mryusha
New Member


Date Joined Dec 2011
Total Posts : 1
   Posted 12/5/2011 1:24 AM (GMT -7)   
Hai
I am 28 yrs female, a week later doc found non obstructive left renal calyceal calculus measu 12 mm no hydronephrosis can any one expains me what does it mean

hopefully some one reply
thanx
Mary
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