Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT05637606
Eligibility Criteria:
Inclusion criteria (all the following)
1. Adult patients ≥ 60 years
2. History of chronic hypertension requiring home therapy.
3. Scheduled for major elective abdominal surgery (laparoscopic, robotic or laparotomic)
4. Expected surgical duration of at least 3 hours.
5. Needing invasive arterial and hemodynamic monitoring as decided by the attending anesthetist, according to the rules of good clinical practice of each involved center.
AND
At increased risk of postoperative complications (at least one of the following):
1. American Society of Anesthesiologists (ASA) class 3 or 4
2. Known or documented history of coronary artery disease (angina, myocardial infarction or acute coronary syndrome).
3. Known or documented history of peripheral vascular disease.
4. Known or documented history of heart failure requiring treatment.
5. Ejection fraction less than 30% (echocardiography)
6. Signs of diastolic moderate to severe dysfunction or chronic hypertensive cardiomyopathy (echocardiography)
7. Moderate or severe valvular heart disease (echocardiography)
8. Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) Radiographically confirmed or according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.
9. Diabetes currently treated with an oral hypoglycemic agent and/or insulin
10. Morbid obesity (BMI ≥35 kg/m2)
11. Preoperative serum albumin \<30 g/l
12. Anaerobic threshold (if done) \<14 ml/kg/min
13. Exercise tolerance equivalent to six metabolic equivalents (METs) or less as defined by American College of Cardiology/American Heart Association guidelines
Exclusion criteria
1. Refusal of consent
2. Chronic kidney disease with glomerular filtration rate \<30 ml/min/1.73 m2 or requiring renal-replacement therapy for end-stage renal disease
3. Acute cardiovascular event, including acute or decompensated heart failure and acute coronary syndrome (within prior 30 days).
4. Urgent or time-critical surgery
5. Aortic or Renal vascular surgery (including nephrectomy)
6. Liver Surgery
7. Neurosurgery
8. Surgery for palliative treatment only or ASA physical status 5
9. Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05637606
Study Brief:
Protocol Section:
NCT05637606