PREDICT study

Recruiting

• Conditions: Abdominal surgery

• Registration Number: jRCTs062250022

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-30
• Last Update Posted: 2025-05-30

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: single assignment

Primary Outcome Measures

Name	Time	Method
-		Total time (minutes) below a mean arterial pressure (MAP) of 65 mmHg

Secondary Outcome Measures

Name	Time	Method
Number of episodes below a MAP of 55, 60, and 65 mmHg		Number of episodes of mean arterial pressure (MAP) below 55, 60, and 65 mmHg
Minimum MAP (mmHg)		Minimum mean arterial pressure (MAP) recorded in mmHg
Incidence of postoperative acute kidney injury and delirium		Incidence of postoperative acute kidney injury and delirium
30-day mortality after surgery	30 days	Mortality rate within 30 days after surgery
Compliance rate of intervention		Compliance rate of the intervention
Incidence below a MAP of 65 mmHg		Incidence of mean arterial pressure (MAP) below 65 mmHg
Time-weighted average mean arterial pressure below a MAP of 65 mmHg		Time-weighted average of mean arterial pressure (MAP) below 65 mmHg
Total time (minutes) and incidence below a MAP of 55 and 60 mmHg		Total time (in minutes) and incidence of mean arterial pressure (MAP) below 55 and 60 mmHg
Time-weighted average mean arterial pressure below a MAP of 55 and 60 mmHg		Time-weighted average of mean arterial pressure (MAP) below 55 and 60 mmHg
Area under the curve below a MAP of 55, 60, and 65 mmHg		Area under the curve of mean arterial pressure (MAP) below 55, 60, and 65 mmHg