Organ dysfunction after noncardiac surgery: a prospective observational study

JRCT ID: jRCT1040240149

Registered date:17/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Diseases requiring noncardiac major surgery
• Date of first enrollment: 17/12/2024
• Target sample size: 200
• Study type: Observational

Outcome(s)

• Primary Outcome: A composite outcome consisting of acute kidney injury or myocardial injury within 7 days postoperatively

Secondary Outcome

Acute kidney injury (AKI) within 7 days after surgery
Acute kidney disease (AKD) and chronic kidney disease (CKD) after surgery
Myocardial injury within 7 days and within 30 days after surgery
Postoperative cognitive dysfunction
Postoperative delirium
Resuscitated cardiac arrest within 30 days after surgery
Major cardiovascular event within 30 days after surgery
Cerebrovascular complications within 30 days after surgery
New-onset atrial fibrillation within 30 days after surgery (with symptoms of hypotension, angina, heart failure, or requiring drug therapy or defibrillation)
Unexpected postoperative intensive care unit admission
Postoperative renal replacement therapy
Death from any cause within 7 days, 30 days, 90 days, 1 year after surgery
Post-anesthesia care unit (PACU) length of stay
Postoperative hospital stay

Key inclusion & exclusion criteria

• Age minimum: >= 45age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Men and women aged 45 or older
2) Patients scheduled to undergo esophagectomy, hepatectomy, biliary surgery, pancreatectomy, abdominal aortic replacement, total cystectomy, or adrenalectomy
3) Patients with an ASA-PS (American Society of Anesthesiologists physical status) of 1 to 4.
4) Patients who have provided written informed consent

Exclude criteria

1) Patients who are pregnant or suspected of being pregnant
2) Patients whose will cannot be confirmed
3) Patients on dialysis
4) Patients with a serum creatinine level of >= 4.0 mg/dL at least once within 3 months prior to surgery
5) Patients who have had acute kidney disease, cerebral infarction, cerebral hemorrhage, transient ischemic attack, acute myocardial infarction, angina pectoris, or acute heart failure (including acute exacerbation of chronic heart failure) within 30 days prior to surgery
6) Patients on mechanical ventilation with tracheal intubation prior to surgery
7) Patients receiving continuous intravenous inotropic or vasoconstrictive agents prior to surgery
8) Patients with preoperative shock vital signs
9) Patients with incomplete or erroneous data to be analyzed
10) Patients undergoing emergency surgery
11) Patients who have been the subject of this study in the past
12) Patients who are deemed by the investigators to be unsuitable for the study

Related Information

• Primary Sponsor: Nakanishi Toshiyuki
• Source(s) of Monetary Support: Japan Society for the Promotion of Science,Nitto Foundation