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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03244189
Other study ID # Pro00083271
Secondary ID 1U01DK110988
Status Completed
Phase N/A
First received
Last updated
Start date October 4, 2017
Est. completion date May 31, 2024

Study information

Verified date June 2024
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A randomized clinical trial to investigate the impact of increased fluid intake and increased urine output on the recurrence rate of urinary stone disease (USD) in adults and children. The primary aim of the trial is to determine whether a multi-component program of behavioral interventions to increase fluid intake will result in reduced risk of stone disease progression over a 2-year period.


Description:

This is a two arm randomized controlled trial that incorporates pragmatic features, an adaptable intervention, patient choice, and remote monitoring of fluid intake through a "smart" water bottle. The study period is 24 months and will enroll approximately 1642 participants. Randomization will be stratified within a study site by age (adult vs. adolescent) and first time vs. recurrent stone former. Intervention and control arm study participants will receive a smart water bottle that records daily fluid consumption, usual care including guideline-based recommendations of adequate fluid intake to decrease kidney stone recurrence, and periodic 24 hour urine collections, imaging (low-dose CT scan or ultrasound) and follow-up questionnaires.


Recruitment information / eligibility

Status Completed
Enrollment 1658
Est. completion date May 31, 2024
Est. primary completion date May 18, 2024
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: 1. Aged = 12 years 2. At least 1 symptomatic stone event (passage or procedural intervention) within 3 years prior to enrollment or a symptomatic stone event within 5 years if the patient also has new stone formation detected on imaging during the last 5 years. Symptomatic stone defined as any of the following: 1. Stone passage 2. Procedural intervention 3. Radiographically or ultrasonographically confirmed stone with any of the following: i. Gross hematuria ii. Renal colic or atypical abdominal pain attributed to the stone, as determined by a treating provider iii. A clinical pattern of intermittent symptoms consistent with intermittent obstruction at the ureteropelvic junction, as determined by a treating provider 3. Low 24-hr urine volume 1. =18 years old: <2.0 L/day 2. <18 years old: <25 ml/Kg/day up to 2.0L/day 4. Able to provide informed consent (parental permission for children) 5. Owning and willing to use a smartphone or other device (e.g., tablet) compatible with the study-provided wireless enabled "smart" bottle Exclusion Criteria: 1. Spinal cord injury 2. Currently undergoing active treatment for cancer except basal cell skin cancer, or patients with a history of cancer who completed their initial therapy <1 year before screening. 3. Known infectious (struvite), monogenic or other causes of stone disease for which therapies are likely to significantly alter course of stone disease 1. Cystinuria 2. Primary hyperoxaluria 3. Primary xanthinuria 4. Primary hyperparathyroidism 5. Sarcoidosis 6. Medullary sponge kidney 4. History or presence of hyponatremia (serum sodium <130 mmol/L) or hypo-osmolality (serum osmolality <275 mosm/kg) 5. Study participants with comorbidities that preclude high fluid intake or prior surgery precluding high fluid intake or leading to GI fluid losses 1. History of or current Crohn's disease, ulcerative colitis, short gut syndrome (e.g. ileostomy, bowel bypass surgery to treat obesity, small bowel resection), chronic diarrhea, or GI tract ostomy. 2. History of malabsorptive (e.g., Roux-en-Y gastric bypass) or restrictive (e.g., sleeve gastrectomy) bariatric surgery procedures 3. Congestive heart failure i. NYHA class II or greater, and/or ii. Hospital admission in the past year for heart failure d. Lung disease with a home oxygen requirement e. Chronic kidney disease (eGFR <30 ml/min/1.7 m2 over a 3-month period) i. For adults (age =18), we will use the CKD-Epi equation which requires the measurement of serum creatinine only. ii. For children (age <18), we will use the bedside Schwartz (CKiD) formula. f. Nephrotic syndrome (>3.5 grams of protein per 24 hours) g. Cirrhosis with ascites 6. Women who are currently pregnant or planning pregnancy within 2 years. 7. Renal transplant recipient 8. Bedridden study participants (ECOG = 3) 9. Uncorrected anatomical obstruction of the urinary tract 10. History of recurrent urinary tract infections (> 3 UTI/year proven by urine culture) 11. Exclusions due to medication use: 1. Chronic use of lithium 2. Long-term glucocorticoid use (> 7.5 mg prednisone daily for > 30 days prior to enrollment) 3. Intake of narcotic medication on a daily basis for >30 days prior to enrollment 4. Supplemental Vitamin C (> 1 g daily) 12. Individuals with stones that have developed after the initiation of medications that are strongly associated with USD such as carbonic anhydrase inhibitors (acetazolamide, topiramate, zonisamide), high dose vitamin C (> 1 g daily), high dose calcium supplementation (> 1,200 mg daily) AND who have discontinued or plan to discontinue these medications. 13. Individuals with stones composed of medications that may crystallize in the urine (guaifenesin, sulfonamides, triamterene, and the protease inhibitors indinavir and nelfinavir) AND who have discontinued or plan to discontinue these medications. Note: Individuals who are on long-term medications that increase the risk of stone disease, who cannot stop these medications due to other chronic conditions (e.g., HIV) and who may reduce their risk for stone recurrence through increased fluid intake, will be eligible to participate in the trial. Examples of these medications include: 1. Carbonic anhydrase inhibitors (acetazolamide, topiramate, zonisamide) 2. Medications that may crystallize in the urine (guaifenesin, sulfonamides, triamterene, and the protease inhibitors indinavir and nelfinavir). 14. Study participants <2 yrs life expectancy 15. Non-English Speakers 16. History of Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) 17. Anatomical urologic abnormalities including ileal conduits, horseshoe kidney, megaureter or solitary kidney. 18. Psychiatric conditions impairing compliance with the study 19. Vulnerable population (prisoner and/or cognitive impairment that the investigator feels will impact the study participant's ability to participate in the protocol) 20. Individual who will be unable to participate in the protocol in the judgment of the investigator.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Fluid prescription
The additional amount of fluid that the participant will need to consume each day, using the smart water bottle, in order to meet the study-specified urine output. This fluid is in addition to any other sources of fluid (ex. cups of coffee, bottled sports drink) that the participant consumes each day.
Financial incentive
Participants in the Intervention Arm who meet their fluid intake goal on randomly selected days will receive a small payment for that day.
Structured Problem Solving
Structure Problem Solving involves interactions with health coaches to help participants develop feasible solutions to overcoming personal barriers to maintaining the prescribed fluid intake.

Locations

Country Name City State
United States Cleveland Clinic Cleveland Ohio
United States Children's Hospital Dallas Texas
United States University of Texas Southwestern Dallas Texas
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States University of Pennsylvania Philadelphia Pennsylvania
United States Mayo Clinic Rochester Minnesota
United States Washington University, St. Louis Saint Louis Missouri
United States University of Washington Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
Duke University National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stone passage observed and/or captured by the study participant. Will be measured by the time from Baseline to the passage of 1 or more stones by a participant. From Baseline through 24 months.
Primary Procedural intervention for symptomatic stone From Baseline through 24 months; will be measured by the time from Baseline to a procedure to remove a symptomatic stone by a participant. From Baseline through 24 months.
Primary Any procedural intervention for removal of asymptomatic renal or ureteral stone Will be measured by the time from Baseline to a procedure to remove an asymptomatic stone by a participant. From Baseline through 24 months.
Secondary Asymptomatic formation of new stone detected by imaging Will be measured by the time from Baseline to the formation of an asymptomatic stone by a participant. From Baseline through 24 months.
Secondary Growth of existing stone by = 2 mm in any dimension detected by imaging Comparison of the size of any stone on first observation versus later observations or at passage. Will be measured primarily through imaging (CT scan or ultrasound). From Baseline through 24 months.
Secondary Composite outcome: symptomatic stone recurrence, asymptomatic stone formation, increase of existing stone by =2 mm in any dimension detected by imaging From Baseline through 24 months.
Secondary 24 hour urine total volume Will measure and compare 24 hour urine volumes from screening through 24 months. From Baseline through 24 months.
Secondary Costs of study interventions and treatments for USD during the follow-up period Compared total between Baseline and the Month 24 visit.
Secondary Presence of lower urinary tract symptoms (Comprehensive Assessment of Self-reported Urinary Symptoms) Will compare the results of the CASUS questionnaires completed throughout the study From Baseline through the Month 24 visit.
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