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Gelatin in ICU and Sepsis

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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02715466
Acronym
GENIUS
Enrollment
167
Registered
2016-03-22
Start date
2016-04-30
Completion date
2021-12-08
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypovolemia

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.

Interventions

DRUGBalanced gelatine solution

Gelaspan combined with Sterofundin ISO

DRUGBalanced electrolyte solution

Sterofundin ISO

Sponsors

B. Braun Melsungen AG
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Time Until First/Initial Hemodynamic Stabilization48 hours after treatment startTime from first administration of IMP to first achievement of confirmed hemodynamic stability

Secondary

MeasureTime frameDescription
Length of Stay (LOS) in the Intensive Care Unit (ICU)Intensive care unit (ICU) discharge or day 28Length of stay (LOS) in the intensive care unit (ICU)= Date of ICU discharge - date of ICU admission + 1

Countries

Austria, Czechia, France, Germany, Spain

Participant flow

Participants by arm

ArmCount
Gelatine
Balanced gelatine solution Balanced gelatine solution: Gelaspan combined with Sterofundin ISO Balanced electrolyte solution: Sterofundin ISO
83
Electrolyte
Balanced electrolyte solution Balanced electrolyte solution: Sterofundin ISO
84
Total167

Baseline characteristics

CharacteristicElectrolyteTotalGelatine
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
50 Participants104 Participants54 Participants
Age, Categorical
Between 18 and 65 years
34 Participants63 Participants29 Participants
Age, Continuous65.9 years
STANDARD_DEVIATION 14.14
65.6 years
STANDARD_DEVIATION 14.13
65.3 years
STANDARD_DEVIATION 14.2
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants2 Participants1 Participants
Race (NIH/OMB)
White
83 Participants165 Participants82 Participants
Region of Enrollment
Austria
6 participants12 participants6 participants
Region of Enrollment
Czechia
9 participants19 participants10 participants
Region of Enrollment
France
2 participants2 participants0 participants
Region of Enrollment
Germany
61 participants120 participants59 participants
Region of Enrollment
Spain
6 participants14 participants8 participants
Sex: Female, Male
Female
20 Participants41 Participants21 Participants
Sex: Female, Male
Male
64 Participants126 Participants62 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
11 / 8318 / 84
other
Total, other adverse events
55 / 8354 / 84
serious
Total, serious adverse events
30 / 8334 / 84

Outcome results

Primary

Time Until First/Initial Hemodynamic Stabilization

Time from first administration of IMP to first achievement of confirmed hemodynamic stability

Time frame: 48 hours after treatment start

Population: Intent-to-treat set

ArmMeasureValue (MEAN)Dispersion
GelatineTime Until First/Initial Hemodynamic Stabilization4.7 hoursStandard Deviation 5.88
ElectrolyteTime Until First/Initial Hemodynamic Stabilization5.8 hoursStandard Deviation 6.46
Secondary

Length of Stay (LOS) in the Intensive Care Unit (ICU)

Length of stay (LOS) in the intensive care unit (ICU)= Date of ICU discharge - date of ICU admission + 1

Time frame: Intensive care unit (ICU) discharge or day 28

Population: Intent-to-treat set

ArmMeasureValue (MEAN)Dispersion
GelatineLength of Stay (LOS) in the Intensive Care Unit (ICU)11.9 daysStandard Deviation 9.32
ElectrolyteLength of Stay (LOS) in the Intensive Care Unit (ICU)12.8 daysStandard Deviation 10.98

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026