Gelatin in ICU and Sepsis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypovolemia

Intervention / Treatment
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* Drug: Balanced gelatine solution
* Drug: Balanced electrolyte solution


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gelatine<br>Balanced gelatine solution | Drug: Balanced gelatine solution<br>* Gelaspan combined with Sterofundin ISO<br>Drug: Balanced electrolyte solution<br>* Sterofundin ISO<br>|
| Active Comparator: Electrolyte<br>Balanced electrolyte solution | Drug: Balanced electrolyte solution<br>* Sterofundin ISO<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time until first/initial hemodynamic stabilization |  | 48 hours after treatment start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay (LOS) in the intensive care unit (ICU) |  | Intensive care unit (ICU) discharge or day 28 |