Perioperative usefulness of Samtus

JRCT ID: jRCTs031230062

Registered date:01/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patient after cardiovascular surgery for congenital heart disease
• Date of first enrollment: 02/06/2023
• Target sample size: 32
• Study type: Interventional
• Intervention(s): Dissolve 8 mg or 16 mg of sodium tolvaptan phosphate (SAMTAS) for intravenous infusion in 4 mL of saline or 5% glucose solution and further dilute the dissolved drug with 50 mL of saline or 5% glucose solution before use. When used, the drug should be administered intravenously over 1 hour once a day (not as a rapid intravenous infusion (bolus)). As a rule, the treatment period is 7 days (maximum 14 days). The initial starting dose is 0.2 mg/kg/day, and the physician will assess efficacy on a daily basis. If an increase in dose is deemed necessary, the dose should be increased by 0.1 mg/kg/day (maximum 0.3 mg/kg/day). On the other hand, if a dose reduction is necessary due to the appearance of dehydration that worsens circulatory and respiratory kinetics, the dose should be reduced by 0.1 mg/kg/day.

Outcome(s)

• Primary Outcome: 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

A) Preoperative evaluation items
1) Basic patient background: age at surgery, gender, weight at surgery, height at surgery, underlying disease
2) Preoperative diuretic use, drug name and dosage, and history of cardiac surgery
B) Intraoperative evaluation items
1) Name of surgery, presence or absence of emergency surgery
2) Intraoperative evaluation items: duration of surgery, duration of cardiopulmonary resuscitation, duration of aortic blockade, intraoperative fluid balance, and minimum rectal temperature
C) Postoperative evaluation items
1) PF ratio during postoperative ventilator management (efficacy against heart failure judged as the percentage of improvement from baseline (before Samtas administration) to the last dose of Samtas), postoperative intubation (ventilator use) time, intensive care unit stay time, length of hospital stay, electrocardiographic changes
2) Postoperative urine output (per day), drainage volume (per day), fluid balance (per day), and central venous pressure (all four items were evaluated for each underlying disease and surgery)
3) Time of use and amount of Samtas, names and amounts of diuretics other than Samtas
4) Postoperative blood collection results: blood count (white blood cell count, red blood cell count, hemoglobin, hematocrit, platelet count, white blood cell fraction (neutrophil, eosinophil, lymphocyte, monocyte, basophil, other)), coagulation (PT, APTT, fibrinogen), Na, K (Na and K should be determined within 24 hours after the start of Samtas treatment at least) BUN, Cre, eGFR, AST, ALT, gamma-GTP, t-bil, Alb, plasma AVP concentration, BNP concentration, renin activity (blood samples will be collected daily from the day following the start of treatment until the day following the end of treatment for about 1 week)
5) Number of postoperative observation days

Key inclusion & exclusion criteria

• Age minimum: >= 1month old
• Age maximum: < 18age old
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Kato Hideyuki
• Source(s) of Monetary Support: University of Tsukuba Hospital