HypovolemiaPhase 4GENIUSNCT02715466
Gelatin in ICU and Sepsis
A Phase 4 study testing Balanced gelatine solution and Balanced electrolyte solution in people with Hypovolemia, run by B. Braun Melsungen AG at 12 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypovolemia
- What is being tested?
- Balanced gelatine solution and Balanced electrolyte solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 12 sitesin 5 countries
- Study dates
- Apr 2016to 8 Dec 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
Germany6 sites
Universitätsklinikum Aachen
Aachen, 52074
Klinikum Bremen-Mitte
Bremen, 28177
Universitätsklinikum Frankfurt
Frankfurt am Main, 60590
Universitätsinstitut - Johannes Wesling Klinikum Minden
Minden, 32427
Universitätsmedizin Rostock
Rostock, 18057
Universitätsklinikum Tübingen
Tübingen, 72076
France2 sites
Université de Nantes
Nantes, 44093
Hôpital Pasteur 2 - CHU de Nice
Nice, 06000
Spain2 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Universitario La Paz
Madrid, 28046
Czechia1 site
Masarykova nemocnice v Ústí nad Labem, o.z.
Ústí nad Labem, 401 13
About this study
Official title: 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
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.
- Conditions
- Hypovolemia
- Being tested
- Balanced gelatine solution, Balanced electrolyte solution
- Medical subject headings
- Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balanced gelatine solutionDrug
Gelaspan combined with Sterofundin ISO
Balanced electrolyte solutionDrug
Sterofundin ISO
| Study group | Role | What they receive |
|---|---|---|
| Gelatine | Experimental | Balanced gelatine solution Receives: Drug: Balanced gelatine solution; Drug: Balanced electrolyte solution |
| Electrolyte | Active comparator | Balanced electrolyte solution Receives: Drug: Balanced electrolyte solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Until First/Initial Hemodynamic Stabilization
Time from first administration of IMP to first achievement of confirmed hemodynamic stability
Measured: 48 hours after treatment start
Secondary outcomes (1)
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
Measured: Intensive care unit (ICU) discharge or day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study startApr 2016
- Primary completion8 Dec 2021
- Study completion8 Dec 2021
Why it stopped: recommended by DSMB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypovolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gernot Marx, Prof. Dr. med., Study chair, Universitätsklinikum Aachen,Klinik für Operative Intensivmedizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02715466
- Sponsor's protocol ID
- HC-G-H-1209
- Acronym
- GENIUS
- Status last verified
- Aug 2025
- First submitted
- 17 Mar 2016
- Last updated
- 19 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Marx G, Zacharowski K, Ichai C, Asehnoune K, Cerny V, Dembinski R, Ferrer Roca R, Fries D, Molnar Z, Rosenberger P, Sanchez-Sanchez M, Schurholz T, Dehnhardt T, Schmier S, von Kleist E, Brauer U, Simon TP. Efficacy and safety of early target-controlled plasma volume replacement with a balanced gelatine solution versus a balanced electrolyte solution in patients with severe sepsis/septic shock: study protocol, design, and rationale of a prospective, randomized, controlled, double-blind, multicentric, international clinical trial : GENIUS-Gelatine use in ICU and sepsis. Trials. 2021 Jun 2;22(1):376. doi: 10.1186/s13063-021-05311-8.
PubMed 34078421
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02715466
- Acronym / sponsor ID
- GENIUS / HC-G-H-1209
- Conditions
- Hypovolemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recommended by DSMB
- Enrolment
- 167 participants (actual)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- 8 Dec 2021 (actual)
- Study completion
- 8 Dec 2021 (actual)
- First posted
- 22 Mar 2016 (estimated)
- Results
- Posted 19 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gelatine | Experimental | Drug: Balanced gelatine solution, Drug: Balanced electrolyte solutionBalanced gelatine solution |
| Electrolyte | Active comparator | Drug: Balanced electrolyte solutionBalanced electrolyte solution |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balanced gelatine solutionGelaspan combined with Sterofundin ISO | Drug | Gelatine |
| Balanced electrolyte solutionSterofundin ISO | Drug | Electrolyte, Gelatine |
Primary outcome
Time Until First/Initial Hemodynamic Stabilization
Time frame: 48 hours after treatment start
Time from first administration of IMP to first achievement of confirmed hemodynamic stability
1 secondary outcome
Length of Stay (LOS) in the Intensive Care Unit (ICU)
Time frame: Intensive care unit (ICU) discharge or day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34078421Marx G, Zacharowski K, Ichai C, Asehnoune K, Cerny V, Dembinski R, Ferrer Roca R, Fries D, Molnar Z, Rosenberger P, Sanchez-Sanchez M, Schurholz T, Dehnhardt T, Schmier S, von Kleist E, Brauer U, Simon TP. Efficacy and safety of early target-controlled plasma volume replacement with a balanced gelatine solution versus a balanced electrolyte solution in patients with severe sepsis/septic shock: study protocol, design, and rationale of a prospective, randomized, controlled, double-blind, multicentric, international clinical trial : GENIUS-Gelatine use in ICU and sepsis. Trials. 2021 Jun 2;22(1):376. doi: 10.1186/s13063-021-05311-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gernot Marx, Prof. Dr. med. study chair
Universitätsklinikum Aachen,Klinik für Operative Intensivmedizin
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Balanced gelatine solution and Balanced electrolyte solution in people with Hypovolemia, run by B. Braun Melsungen AG at 12 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, France, Spain, Austria, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Until First/Initial Hemodynamic Stabilization (time frame: 48 hours after treatment start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02715466, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.