heart failure patient with high risk of kidney failure kidney outcome heart failure patient high risk of kidney failure tolvaptan
Conditions
Interventions
1. tolvaptan was given via per oral to participant for first three days of intervention at 7.5mg per day
2. furosemide was given via intravenous or per oral to participant (dose of furosemide was dep
Placebo Comparator Drug,Placebo Comparator Drug
tolvaptan group,control group
Sponsors
Navamindradhiraj University Research Fund
Thai Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.hospitalized heart failure patient 2.chronic kidney disease stage 3-4 3.in case of absence baseline renal function 3.1 patient with creatinine more than or equal 2mg/dl at admission 3.2 patient with creatinine 1.1 to less than 2mg/dl at admission with equal or more than 70 years old 4.more than 18 years old
Exclusion criteria
Exclusion criteria: 1.Acute Kidney Injury Network stage 3 on admission 2.autosomal dominant polycystic kidney disease 3.pregnancy or breast feeding 4.cirrhosis or liver failure or transaminitis which AST, ALT more than 2times of upper normal limit 5.serum sodium more than 145mEq/L 6.concomitant use with CYP3A inhibitor such as ketoconazole, itraconazole, fluconazole, clarithromycin, erythromycin, indinavir, ritonavir, diltiazem, verapamil 7.concomitant use with CYP3A inducer such as rifampin, barbiturate, phenytoin, carbamazepine 8.concomitant use with P-gp inhibitor such as cyclosporin 9.history of drug allergy with tolvaptan or furosemide 10.unstable vital sign 11.postcardiac arrest 12.unable to access tolvaptan within 24 hours after admission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| composite kidney outcome 7 days creatinine, treatment with kidney replacement therapy, death | — |
Secondary
| Measure | Time frame |
|---|---|
| incidence of acute kidney injury 7 days creatinine,incidence of kidney replacement therapy 7 days treatment with kidney replacement therapy,incidence of death 7 days number of death,incidence of hyponatremia, hypokalemia 7 days serum sodium, serum potassium,urine volume 7 days urine volume,dose of furosemide 7 days furosemide dose,composite congestion score 7 days composite congestion score | — |
Countries
Thailand
Contacts
Public ContactNitcha Suphatheerawatr
Faculty of Medicine Vajira Hospital
Outcome results
None listed