Evaluation of the Safety of Olprinone for Low Central Venous Pressure Management during Open Hepatectomy

JRCT ID: jRCTs041230111

Registered date:01/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hepatocellular carcinoma, Intrahepatic cholangiocarcinoma, Metastatic liver cancer, Perihilar cholan
• Date of first enrollment: 12/01/2024
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Olprinone is administered during open hepatectomy.

Outcome(s)

Primary Outcome

DLT : Dose Limiting Toxicity
1) During surgery:
Rise in blood pressure due to positive inotropic effects that doesn't respond to antihypertensive drugs (systolic blood pressure >180mmHg).
Drop in blood pressure due to vasodilatory effects that doesn't respond to pressor agents (diastolic blood pressure <70mmHg ).
Occurrence of arrhythmias (paroxysmal atrial tachycardia, atrial fibrillation, atrial flutter, ventricular tachycardia (including Torsade de pointes), ventricular fibrillation).
Excessive tachycardia (heart rate >140 beats/minute).
2) From the end of surgery to 24 hours post-operation:
Occurrence of arrhythmias (paroxysmal atrial tachycardia, atrial fibrillation, atrial flutter, ventricular tachycardia (including Torsade de pointes), ventricular fibrillation).
Excessive tachycardia (heart rate >140 beats/minute).
Presence or absence of renal dysfunction immediately after surgery (upon ICU admission)(increase in serum creatinine (Cr): proportion of Cr>2.00).
3) From the day after surgery:
Presence or absence of renal dysfunction on the 1st, 3rd, 5th,and 7th days post-operation (increase in serum creatinine (Cr): proportion of Cr>2.00).

Secondary Outcome

1) Temporal changes in central venous pressure (measured every 20 seconds from the start of the surgery, but particularly evaluated at the following times):
At the start of surgery
Before olprinone loading
Before liver transection
During liver transection:
Since the duration of liver transection varies from case to case, mean and median values are used.
After liver transection
At the end of surgery
2) The proportion of reduction in central venous pressure just before and during liver resection.
3) Hemodynamic parameters obtained with the FloTrac System(measured every 20 seconds from the start of surgery, but especially evaluated at the same times as the above central venous pressure):
Cardiac output
Cardiac index
Stroke volume
Stroke volume index
Stroke volume variation
Systemic vascular resistance
Systemic vascular resistance index
4) Observed arterial pressure(Recorded every 20 seconds from the start of the operation, but especially assessed at the same time as the central venous pressure above).
5) The amount of blood loss during surgery and blood loss during liver resection.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

(1) An open hepatectomy is scheduled.
(2) The registered age is between 18 and 75 years old.
(3) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) is 0 or 1.
(4) There's no obstructive ventilatory impairment (Forced Expiratory Volume in 1 second (FEV1.0%) is >= 70%).
(5) There's no history of angina or myocardial infar ction.
(6) No moderate to severe valvular disease (based on the findings from a transthoracic echocardiogram).
(7) All the following conditions are met:
White blood cell count: between 2,500/mm3 and 10,000/mm3
Platelet count >=100,000/mm3
AST <=100IU/L
ALT <=100IU/L
Total bilirubin <=2.0 mg/dL (<=4.0mg/dL in cases with jaundice)
Serum creatinine <=1.0mg/dL
(8) Written consent for trial participation has been obtained from the patient.

Exclude criteria

(1) Cases with a history of arrhythmia. (Premature ventricular contractions are not included.)
(2) Cases where surgery is conducted without discontinuing antiplatelet drugs.
(3) Cases with a history of hypersensitivity to PDEIII inhibitors.
(4) Cases deemed unsuitable for this trial by the at tending physician.

Related Information

• Primary Sponsor: Sugiura Teiichi