Health Condition 1: I00- Rheumatic fever without heart involvement
Conditions
Interventions
Intervention1: Drug: Mannitol Dose
For our study population the total dose of mannitol used in our study is 20 gm which constitute only on an average 0.4g/Kg. Notably, mannitol may cause AKI in very h
patients with marked mannitol accumulation (plasma osmolal gap greater than 60 to 75 osmol/kg, which reflects a plasma mannitol concentration above 1080 mg/dL) may develop reversible acute kidney inju
Sponsors
The Terry Fox International Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria a) Patients with osteosarcoma and other solid tumors (lung, head and neck region and germ cell tumors) who are planned for Cisplatin at a minimum dose of 75 mg/m2 b) Patients aged 12- 70 years c) Baseline GFR>= 60ml/min d) ECOG performance status
Exclusion criteria
Exclusion criteria: 2. Exclusion Criteria a) Patients undergoing treatment with nephrotoxic drugs (non-steroidal anti-inflammatory drugs, aminoglycosides, amphotericin B, or cephalosporins) or drugs that falsely elevate serum creatinine (sulfonamides) â?° However, if patients received these drugs in the recent past after an appropriate washout period they can be enrolled which depends upon the half-life of the drugs. Details of drug specific wash out period as per: Table No 1: Wash out period Amphotericin Wash out period (4 weeks) NSAID Aminoglycosides Wash out period (5 days) Cyclophosphamide Sulfonamides Drug Half life Amphotericin 15 day NSAID 2-60 hours Aminoglycosides 2-3 hours Cyclophosphamide 3-12 hours Sulfonamide 8-10 hours: normal patient b. Patients having chronic renal disease with GFR c. Patients having hearing impairment d. Previous history of abdominal radiation e. Patients receiving concurrent radiotherapy f. Patients receiving concurrent experimental treatment g. Fluid retention states like heart, liver or respiratory failure h. High likelihood of tumor lysis syndrome i. Presence of structural renal changes on ultrasonography esp. hydronephrosis j. Pregnant or lactating females. k. Patient with previous or current diagnosis of Hepatitis B virus (HBV), hepatitis C virus (HCV) (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening tests positive)â??. l. Any other condition in view of PI/CO-I which might hamper patient safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 To determine the fraction of patients with AKI post first cycle chemotherapy using the S Cr method as accepted in KDIGO classification of AKI (Day 6-8, 13-15, and 20-22 after 1st cycle (the worst value considered for this categorizationTimepoint: after 1st cycle of chemotherapy ( 6-8, 13-15, and 20-22 days after first cycle of chemotherapy (the worst value considered for this categorization | — |
Secondary
| Measure | Time frame |
|---|---|
| To study acute fall and chronic fall in GFR Timepoint: Acute fall in GFR measured (between 6-22 days after 1st cycle) and chronic fall in GFR measured just prior to the 4th cycle [i.e. approximately 10-14 weeks from baseline] of Cisplatin based chemotherapy and 6 months post randomization using radio isotopic DTPA GFR method.;To study chronic fall in GFR compared to:Timepoint: Baseline, just prior to the 4th cycle [i.e. approximately 10-14 weeks from baseline] of Cisplatin based chemotherapy and 6 months post randomization using the S. Cr method (CKD EPI eGFR).;To study electrolyte disturbances (Na/K/Ca/Mg)Timepoint: Measured at day 6-8 after 1st cycle and just prior to the 4th cycle [i.e. approximately 10-14 weeks from baseline] of Cisplatin based chemotherapy and 6 months after randomization. | — |
Countries
India
Contacts
Public ContactDr Jyoti Bajpai
Tata Memorial Centre
Outcome results
None listed