Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Cisplatin is a major anti-neoplastic drug used for the treatment of solid tumors. Its chief dose limiting side effect is nephrotoxicity. Twenty percent of patients receiving high-dose cisplatin undergo severe renal dysfunction. Acetazolamide and N-acetylcysteine (NAC) ameliorated Cisplatin-induced nephrotoxicity in rats. No study to date evaluated the protective effect of acetazolamide or NAC against cisplatin nephrotoxicity in humans.
Aim of the study was to evaluate the effect of acetazolamide or NAC against cisplatin nephrotoxicity in humans compared to mannitol and to each other.
Patients and methods. A total 52 patients receiving standard hydration measures for cisplatin were randomized to three groups: 20 patients receiving mannitol, 15 patients receiving acetazolamide and 17 patients receiving NAC. Patients' kidney function was monitored using serum creatinine, creatinine clearance and blood urea nitrogen; kidney injury was assessed using RIFLE criteria. Patients' liver function tests and hematological parameters were also monitored.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mannitol group | Active Comparator | patients received mannitol 20 % 100 ml half an hour before cisplatin and saline hydration. |
|
| ACTZ group | Active Comparator | patients received acetazolamide 250 mg half an hour before cisplatin with saline hydration. |
|
| NAC group | Active Comparator | patients received acetylcysteine NAC (600 mg every 12 hours) for 4 doses beginning 24 hours before cisplatin with saline hydration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetazolamide | Drug | patients received acetazolamide 250 mg half an hour before cisplatin with saline hydration.for prevention of cisplatin nephrotoxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Creatinine | Blood samples collected and measured in laboratory with the unit mg/dL | change from baseline after 3 cycles separated by 21 days |
| Creatinine clearance according to Cockroft-Gault equation | calculated using globalrph calculators , unit ml/min | change from baseline after 3 cycles separated by 21 days |
| Acute kidney injury | Acute kidney injury assessed by RIFLE criteria that was calculated for patients | change from baseline after 3 cycles separated by 21 days |
| Blood urea nitrogen (BUN) | Blood samples collected and measured in laboratory with the unit mg/dl | change from baseline after 3 cycles separated by 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Aspartate Transaminase (AST) | Liver function tests were monitored by measuring AST for change from baseline after 3 cycles separated by 21 days | change from baseline after 3 cycles separated by 21 days |
| hemoglo bin |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086 | Acetazolamide |
| D000111 | Acetylcysteine |
| D008353 | Mannitol |
| D012965 | Sodium Chloride |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Acetylcysteine | Drug | patients received NAC (600 mg every 12 hours) for 4 doses beginning 24 hours before cisplatin with saline hydration.for prevention of cisplatin nephrotoxicity |
|
|
| Mannitol | Drug | patients received mannitol 20 % 100 ml half an hour before cisplatin and saline hydration. |
|
| saline | Drug | saline hydration 2500 ml before cisplatin therapy |
|
| Cisplatin | Drug | patients with tumours already prescribed cisplatin |
|
hemoglobin concentration g/dl was monitored for change from baseline after 3 cycles separated by 21 days
| change from baseline after 3 cycles separated by 21 days |
| adverse events | Monitoring adverse events: to evaluate the difference between three groups regarding frequency of adverse events. | change from baseline after 3 cycles separated by 21 days |
| Alanine Transaminase (ALT) | Liver function tests were monitored by measuring ALT for change from baseline after 3 cycles separated by 21 days | change from baseline after 3 cycles separated by 21 days |
| platelets count | platelets count cells per ml was monitored for change from baseline after 3 cycles separated by 21 days | change from baseline after 3 cycles separated by 21 days |
| total leucocyte count | total leucocyte count cells per ml was monitored for change from baseline after 3 cycles separated by 21 days | change from baseline after 3 cycles separated by 21 days |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D002241 | Carbohydrates |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |