Preoperative hydration for Prevention of hypotension after carotid artery stenting

JRCT ID: jRCTs051240031

Registered date:13/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: carotid stenosis
• Date of first enrollment: 08/08/2024
• Target sample size: 250
• Study type: Interventional
• Intervention(s): Study subjects assigned to the treatment group will receive 60 mL/hour (minimum 500 mL, maximum 1,000 mL) of each 500 mL formulation of saline, acetic acid Ringer's solution, and lactate Ringer's solution, in a combination at the physician's discretion, before the start of endovascular treatment.

Outcome(s)

• Primary Outcome: Postoperative prolonged hypotension

Secondary Outcome

-Period of total hospitalization
-Period of stay in ICU, HCU, SCU, or equivalent postoperative unit
-Overall ischemic stroke from intraoperative to postoperative day 3
-mRS at 30 days after surgery
-Heart failure (pulmonary edema) up to 3 days postoperatively
-LAVI in transthoracic echocardiography

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

(1)Patients scheduled to undergo carotid stenting for carotid artery stenosis
(2)Eligible age at the time of consent: 20 to 85 years old
(3)mRS 0-2 before surgery
(4)Consent can be obtained in writing from the patient

Exclude criteria

(1)Patients with a history of carotid endarterectomy or carotid stenting in the target vessel for carotid artery stenting
(2)Patients with a history of heart failure
(3)Patients with a left ventricular ejection fraction (EF) of less than 50%.
(4)Systolic blood pressure less than 90 mmHg
(5)Patients who cannot discontinue antihypertensive drugs and diuretics on the day of surgery.
(6)Patients on maintenance dialysis
(7) Patients scheduled to participate or currently participating in other clinical trials or clinical studies (interventional studies)
(8) Other patients who are judged by the Principal Investigator to be inappropriate to participate in this study.

Related Information

• Primary Sponsor: Maekawa Kota
• Secondary Sponsor: Ohta Tsuyoshi,Ohara Nobuyuki