Prospective, Controlled, Double-Blind, Randomized Multicentric Study On The Efficacy And Safety Of An Early Target Controlled Plasma Volume Replacement Therapy With A Balanced Gelatine Solution vs A Balanced Electrolyte Solution In Patients With Severe Sepsis

B. Braun Melsungen AG12 sites in 5 countries167 target enrollmentApril 1, 2016

ConditionsHypovolemia

InterventionsBalanced gelatine solution Balanced electrolyte solution

Overview

Phase: Phase 4
Intervention: Balanced gelatine solution
Conditions: Hypovolemia
Sponsor: B. Braun Melsungen AG
Enrollment: 167
Locations: 12
Primary Endpoint: Time Until First/Initial Hemodynamic Stabilization
Status: Terminated
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This prospective, double-blind randomized controlled trial evaluates the differences in terms of efficacy and safety of gelatin based resuscitation as compared to crystalloid based resuscitation in two parallel groups of patients with severe sepsis / septic shock.

Registry

clinicaltrials.gov

Start Date

April 1, 2016

End Date

December 8, 2021

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

B. Braun Melsungen AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female patients ≥ 18 years of age
•Women of child bearing potential must test negative on standard pregnancy test (urine or serum)
•Patients with body weight ≤ 140 kg
•Patients diagnosed severe sepsis / septic shock at admission on Intensive Care Unit who can be enrolled within 90 min after admission OR patients diagnosed severe sepsis / septic shock during Intensive Care Unit 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 passive leg raising (PLR)
•Signed informed consent by patient, legal representative or authorized person or deferred consent

Exclusion Criteria

•Administration of HES, dextrane solutions or \> 500 ml of Gelatin solutions within the 24 h prior to randomization
•Death expected within the next 48 h (moribund patients as defined by ASA ≥ class V)
•Patients for whom the need of pressure infusions are expected
•Patients with confirmed acute SARS-CoV-2 (COVID-19) infection (as available from routine medical records/ patient chart)
•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
•Contraindications according to summary of product characteristics of investigational test and reference product
•Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)