PROSPECTIVE, RANDOMIZED, CONTROLLED, DOUBLE-BLIND, MULTI-CENTRIC, INTERNATIONAL, STUDY ON THE EFFICACY AND SAFETY OF AN EARLY TARGET CONTROLLED PLASMA VOLUME REPLACEMENT THERAPY WITH A BALANCED GELATIN SOLUTION VS A BALANCED ELECTROLYTE SOLUTION IN PATIENTS WITH SEVERE SEPSIS / SEPTIC SHOCK - GENIUS (GELATIN IN ICU AND SEPSIS)

B. Braun Melsungen AG0 个研究点目标入组 608 人开始时间: 2017年8月10日最近更新: 2023年9月26日

适应症

试验速览

暂无简介。

•Male or female patients = 18 and = 85 years of age
•Women of child bearing potential must test negative on standard pregnancy test (urine or serum)
•Patients with body weight = 55 kg and = 140 kg and body mass index (BMI) = 18 kg/m2
•Patients diagnosed severe sepsis / septic shock (refer to section 7.2.1 for definitions) at admission on ICU who can be enrolled within 90 min after admission OR patients diagnosed severe sepsis / septic shock during ICU stay who can be enrolled within 90 min after diagnosis
•Patients where antibiotic therapy has already been started (prior to randomization)
•Patient who are fluid responsive. Fluid responsiveness is defined as increase of > 10% in mean arterial pressure (MAP) after PLR
•Signed informed consent by patient, legal representative or authorized person or deferred consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 304
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 304

•Administration of HES, dextrane solutions or > 500 ml Gelatin solution within the 24 h prior to randomization
•Death expected within the next 48 h (moribund patients as defined by ASA = class V)
•Patients whose medical condition does preclude the PLR manoeuvre
•Patients for whom the need of pressure infusions are expected
•Requirement for renal support (either continuous or discontinuous techniques, including intermittent haemodialysis, haemofiltration and haemodiafiltration)
•Patients receiving therapeutic heparin medication due to chronic coagulation disease / anticoagulation medication (i.e.partial thromboplastin time > 60 sec)
•Acutely burned patients:
•Burns are defined as having any of the following before the administration of investigational products:
•1. Burns = 10 % of body surface area classified as major burns: third-degree burns (syn. full thickness burns) of any size or second-degree burns > 2 inches (ca. 5 cm) wide or second-degree burns on the hands, feet, face, groin, buttocks, or a major joint
•2. Burned area not yet re-epithelialised
•Renal failure with oliguria or anuria
•Severe general oedema
•Severe congestive cardiac failure
•Hypersensitivity to the active substance or ingredients of the IPs
•Hypervolaemia / hyperhydration
•Hyperkalaemia
•Hypercalcaemia
•Metabolic alkalosis
•Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)

发起方