A Randomized Clinical Trial to Evaluate the Effectiveness of Oral Potassium Citrate in Preventing Ureteral Stent Encrustation in Patients Undergoing Ureteroscopy for Uric Acid Kidney Stones

NCT ID: NCT06819553

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-03
• Study Completion Date: 2025-03-01

Brief Summary

This randomized clinical trial aims to evaluate the efficacy of oral potassium citrate in reducing ureteral stent encrustation following ureteroscopy for uric acid kidney stones. The study will assess whether potassium citrate, by raising urinary pH, can prevent encrustation on stents, potentially improving patient outcomes and reducing complications.

Detailed Description

Urolithiasis, particularly uric acid stones, is a prevalent condition with increasing incidence due to factors such as obesity and dietary habits. Ureteroscopy with stent placement is a common intervention for managing ureteral stones. However, the indwelling stents are prone to encrustation, which can lead to significant complications, including infection, obstruction, and discomfort for patients.

Potassium citrate, an alkalinizing agent, has been shown to prevent uric acid stone formation by raising urinary pH and dissolving existing stones. This trial aims to determine whether potassium citrate can also reduce encrustation on ureteric stents following ureteroscopy for uric acid stones.

In this prospective, randomized, controlled trial, patients undergoing ureteroscopy with stent placement for uric acid stones will be randomly assigned to either the intervention group (receiving potassium citrate) or a control group. The primary outcome is the rate of stent encrustation, which will be assessed using a modified scoring system after stent removal. Secondary outcomes include serum electrolyte levels, adverse events, and changes in urinary pH. All patients will be monitored regularly for changes in urine pH and adverse events during the study.

The findings from this trial may provide valuable insights into the role of potassium citrate in preventing ureteric stent encrustation, ultimately improving patient outcomes and reducing the need for additional interventions.

Conditions

Urolithiasis; Stone Ureter

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention Arm (Experimental Arm)Patients receiving potassium citrate.

Oral potassium citrate (15 meq twice daily) to maintain urinary pH between 6.8 and 7.2.

Group Type: EXPERIMENTAL

Oral Potassium Citrate

Intervention Type: DRUG

Evaluate the Effectiveness of Oral Potassium Citrate in Preventing Ureteral Stent Encrustation in Patients Undergoing Ureteroscopy for Uric Acid Kidney Stones

control arm

No oral potassium citrate or any other treatment for stent encrustation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Oral Potassium Citrate

Evaluate the Effectiveness of Oral Potassium Citrate in Preventing Ureteral Stent Encrustation in Patients Undergoing Ureteroscopy for Uric Acid Kidney Stones

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age: ≥18 years old.
• Diagnosis: Patients undergoing ureteral stenting post-ureteroscopy for uric acid kidney stones.
• Urinary pH: ≤5.5 at baseline (acidic urine).
• Willingness to Participate: Patients who provide informed consent to participate in the study.

Exclusion Criteria

Infections: History of febrile urinary tract infection (UTI) at the time of enrollment.

Metabolic Disorders:

Chronic kidney disease (CKD) Stage 3 or higher. History of hyperkalemia. Pregnancy: Pregnant or breastfeeding women. Residual Stones: Patients with residual stone burden after ureteroscopy that may confound outcomes.

Medication Interference: Patients on medications that significantly alter urinary pH (e.g., sodium bicarbonate, acetazolamide) or those contraindicated with potassium citrate.

Other Severe Comorbidities: Any condition that, in the investigator's judgment, would interfere with study participation or pose excessive risk.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

faculty of medicine - Zagazig University

Zagazig, Sharqia Province, Egypt

Countries

Egypt

Other Identifiers

571/13-Aug-2024

Identifier Type: -

Identifier Source: org_study_id