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:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-24 @ 1:03 PM
NCT ID:
NCT03420261
Eligibility Criteria:
Inclusion Criteria:
* • - Undergo elective or emergency abdominal surgery under general anesthesia
* With an estimated surgical duration greater than or equal to 2 hours
* With moderate-to-high risk of postoperative complications defined by an AKI risk index≥ class 3, as defined by the presence of at least 4 of the following factors: age\> 56 years, male gender, intraperitoneal surgery, active congestive heart failure, ascites, hypertension, emergency surgery, mild or moderate renal insufficiency, diabetes mellitus treated by oral or insulin therapy
* Included in Clermont-Ferrand and Montpellier centers
Exclusion Criteria:
* • - Age \<18 years
* Preoperative acute heart failure
* Preoperative acute coronary insufficiency
* Preoperative severe renal failure (defined by creatinine clearance \<30 ml/min or requiring renal replacement therapy)
* Preoperative shock defined by the need for vasoactive amines
* History of allergy with the use of 6% hydroxyethyl starch 130/0.4
* Contraindication to the use of HES: sepsis, burnt patient, renal insufficiency or dialysis, cerebral hemorrhage, ICU patient , hypervolemia, lung edema, dehydration, severe hypernatremia or severe hyperchloremia, severe hepatic insufficiency, congestive heart failure, severe coagulopathy, organ transplant
* Patient's or relative's refusal to participate
* Parturient or breastfeeding woman
* Protected major (guardianship)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03420261
Study Brief:
Protocol Section:
NCT03420261