Perioperative usefulness of Samtus
- Conditions
- Patient after cardiovascular surgery for congenital heart disease
- Registration Number
- JPRN-jRCTs031230062
- Lead Sponsor
- Matsubara Muneaki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 32
1) Patients in the acute phase (within 2 weeks after surgery) after cardiovascular surgery for congenital heart disease
2) Patients with fluid retention in heart failure who have had an inadequate response to loop diuretics and other diuretics
3) Male and female patients between 1 month and less than 18 years of age at the time of surgery.
4) Patients who have been fully informed of the study and who have given written consent of their own free will or that of a surrogate (parent/guardian) after full understanding of the study
1) Patients with an assistive circulatory device
2) Patients with serious cerebrovascular diseases (cerebral infarction, etc.)
3) Patients with a postoperative serum Na concentration of less than 125 mEq/L or greater than 150 mEq/L
4) Patients with a postoperative serum K concentration of 5.5 mEq/L or higher
5) Patients with anuria
6) Patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2 or requiring peritoneal dialysis, etc.)
7) Other patients who are deemed inappropriate as subjects by the Principal Investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effect of Samtas use on fluid retention (change in body weight and urine output (% change in urine output per kg body weight) from baseline (before Samtas administration) to last dose)
- Secondary Outcome Measures
Name Time Method