The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer
- Conditions
- Muscle-Invasive Bladder Carcinoma
- Registration Number
- NCT06215976
- Lead Sponsor
- Cairo University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Non-diabetic adults of age between 18 to 65.<br><br> 2. Chemotherapy naïve patients diagnosed with bladder cancer.<br><br> 3. Patients with stable renal function: eGFR is above 60 ml/min/1.73 m2<br><br>Exclusion Criteria:<br><br> 1. Patients with history of lactic acidosis.<br><br> 2. Patients taking any nephrotoxic medication other than cisplatin (e.g., frusemide,<br> NSAIDs, aminoglycoside or vancomycin).<br><br> 3. Unstable renal function (defined as an increase in serum creatinine of 0.3 mg/dL or<br> greater suddenly in 48 hours according to the acute kidney injury network (AKIN)<br> classification<br><br> 4. Patients with heart failure, acute myocardial infarction or cardiogenic collapse<br> (shock).<br><br> 5. Severe infection and sepsis.<br><br> - Any infection requiring hospitalization.<br><br> - Any infection leading to a need for oxygen, intubation, vasopressors or fluids<br> to support blood pressure.<br><br> 6. Alcohol intake.<br><br> 7. Respiratory failure.<br><br> 8. Severe hepatic impairment (Child-Pugh class C).<br><br> 9. Patients with metastasis.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method serum creatinine (SCr);Human Neutrophil gelatinase-associated lipocalin (NGAL);Cystatin C;Estimated glomerular filtration rate (eGFR)
- Secondary Outcome Measures
Name Time Method FBG;HbA1C;Body weight;Body Mass Index;Blood pH;Blood Lactate Level