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Preoperative hydration for Prevention of hypotension after carotid artery stenting

Efficacy of Preoperative Infusion Therapy for Prolonged Hypotension after Carotid Stenting - PREPARE

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs051240031
Enrollment
250
Registered
2024-05-13
Start date
2024-08-08
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

carotid stenosis Carotid artery stenosis, carotid artery stenting, postoperative prolonged hypotension

Interventions

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 solu
Carotid stenting, preoperative infusion therapy, postoperative prolonged hypotension, saline, Ringer's solution acetate, Ringer's solution lactate

Sponsors

Maekawa Kota
Lead Sponsor
Ohta Tsuyoshi
Collaborator
Ohara Nobuyuki
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Postoperative prolonged hypotension

Secondary

MeasureTime frame
-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

Contacts

Public ContactAya Ako

Kobe City Medical Center General Hospital

c_prepare@kcho.jp+81-78-302-4321

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026