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 @ 11:00 PM
Ignite Modification Date:
2025-12-24 @ 11:00 PM
NCT ID:
NCT01301469
Eligibility Criteria:
Inclusion:
* Male or female (non pregnant) patients; between 18 and 70 years
* Elective non-cardiac surgery (except pancreatic or neurological surgery) with an estimated operation duration of 2 hours or longer
* General anesthesia
* Voluntary consent
Exclusion:
* Patients of ASA-class III or IV, Cardiac insufficiency NYHA classes III. IV
* BMI \< 18 or \> 29
* Patients with daily urine output \< 1L
* Patients on hemodialysis
* Abnormal liver or renal function (i. e. above upper limit of normal range)
* Abnormal coagulation function (prothrombin time (PT) 3 seconds higher than normal or activated partial thromboplastin time (APTT) 10 seconds higher than normal)
* Hgb \< 10g/dl or HCT \< 30%
* Potassium, sodium or chloride above the upper limit of normal of the laboratory
* History of diabetes mellitus
* Known history of a mental or neurological disorder, such as epileptic seizures.
* History of hypertension and/or taking a beta-receptor blocker or history of atrial fibrillation
* Patients with known hypersensitivity and with contraindications to HES or any of the excipients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01301469
Study Brief:
Protocol Section:
NCT01301469