jRCT ロゴ

臨床研究等提出・公開システム

Top

Japanese

May. 30, 2025

July. 17, 2025

jRCTs062250022

Performance of Hemodynamic Management using HPI Algorithm during Intra-abdominal Surgery

PREDICT study

Morimatsu Hiroshi

Okayama University Hospital

2-5-1 Shikata-cho Kita-ku, Okayama

+81-86-235-7327

pb9b45wr@okayama-u.ac.jp

Negayama Ryo

Okayama University Hospital

2-5-1 Shikata-cho Kita-ku, Okayama

+81-86-235-7330

p0w99ped@okayama-u.ac.jp

Recruiting

May. 30, 2025

July. 15, 2025
50

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

other

1.Patient is 18 years or older at the time of consent (regardless of gender)
2.Patient is scheduled for intra-abdominal surgery under general anesthesia that is expected to last more than 120 minutes
3.Patient is scheduled for the use of an arterial blood pressure catheter
4.Serum creatinine (Cr) >=0.80mg/dL
5.Systolic blood pressure >=90mmHg
6.American Society of Anesthesiology (ASA) physical status classification II, III or IV
7.Patients who have received sufficient explanation and informed written consent of their own free will to participate in this study

1.Patients undergoing urgent/emergency surgery
2.Patients suffering from sepsis (according to current Sepsis-3 definition)
3.Patients scheduled for nephrectomy, liver and/or kidney transplantation
4.Patients undergoing dialysis
5.Patients with atrial fibrillation
6.Patients with known intracardiac shunts
7.Patients with known moderate to severe valvular disease
8.Patients with known EF < 30%
9.Patients with a history of chronic heart failure
10.Patient participating in other interventional trials
11.Patients who are pregnant, breastfeeding, or possibly pregnant
12.Patients who are judged to be inappropriate for participation in this study by a local investigator

18age old over
No limit

Both

Abdominal surgery

A hypotension prediction index(HPI) is calculated by using the Acumen IQ sensor and the HemoSphere Advanced Monitoring Platform. When HPI exceeds 85, circulatory management during surgery is performed using interventions according to an algorithm (fluid infusion, blood transfusion, ephedrine hydrochloride, dobutamine hydrochloride, phenylephrine hydrochloride, adrenaline, noradrenaline, atropine sulfate hydrate).

Total time (minutes) below a mean arterial pressure (MAP) of 65 mmHg

1.Incidence below a MAP of 65 mmHg
2.Time-weighted average mean arterial pressure below a MAP of 65 mmHg
3.Total time (minutes) and incidence below a MAP of 55 and 60 mmHg
4.Time-weighted average mean arterial pressure below a MAP of 55 and 60 mmHg
5.Area under the curve below a MAP of 55, 60, and 65 mmHg
6.Number of episodes below a MAP of 55, 60, and 65 mmHg
7.Minimum MAP (mmHg)
8.Incidence of postoperative acute kidney injury and delirium
9.30-day mortality after surgery
10.Compliance rate of intervention

Edwards Lifesciences Corporation
Not applicable
Okayama University Certified Review Board
2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama

+81-86-235-6503

ouh-crrb@adm.okayama-u.ac.jp
Approval

Oct. 22, 2024

none

History of Changes

No Publication date
2 July. 17, 2025 (this page) Changes
1 May. 30, 2025 Detail