A Phase 4 interventional study of Balanced gelatine solution and Balanced electrolyte solution in Hypovolemia, sponsored by B. Braun Melsungen AG. Terminated at 12 sites in 5 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-08-19.
Sponsored by B. Braun Melsungen AG · Phase 4, Interventional, and Treatment
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.
122 studies on the registry are indexed under Hypovolemia; 14 are open to participants now.
This study's enrollment of 167 is above the median of 40 across 61 interventional studies indexed under Hypovolemia.
Browse Hypovolemia studies →B. Braun Melsungen AG is the lead sponsor of 47 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Balanced gelatine solution
Drug: Balanced gelatine solution · Drug: Balanced electrolyte solution
Balanced electrolyte solution
Drug: Balanced electrolyte solution
Gelaspan combined with Sterofundin ISO
Sterofundin ISO
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
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
| Milestone | Gelatine | Electrolyte |
|---|---|---|
| Started | 83 | 84 |
| Completed | 83 | 84 |
| Not completed | 0 | 0 |
Time from first administration of IMP to first achievement of confirmed hemodynamic stability
| hours | Gelatine | Electrolyte |
|---|---|---|
| Time Until First/Initial Hemodynamic Stabilization | 4.7 ± 5.88 | 5.8 ± 6.46 |
Length of stay (LOS) in the intensive care unit (ICU)= Date of ICU discharge - date of ICU admission + 1
| days | Gelatine | Electrolyte |
|---|---|---|
| Length of Stay (LOS) in the Intensive Care Unit (ICU) | 11.9 ± 9.32 | 12.8 ± 10.98 |
Collected over From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days). Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gelatine | 11/83 (13.3%) | 30/83 (36.1%) | 55/83 (66.3%) |
| Electrolyte | 18/84 (21.4%) | 34/84 (40.5%) | 54/84 (64.3%) |
| Event | Gelatine | Electrolyte |
|---|---|---|
| Multiple organ dysfunction syndromeGeneral disorders | 7/83 | 12/84 |
| Septic shockInfections and infestations | 6/83 | 9/84 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 2/83 | 4/84 |
| Cardiac arrestCardiac disorders | 0/83 | 4/84 |
| Failure to anastomoseInjury, poisoning and procedural complications | 3/83 | 3/84 |
| Ventricular tachycardiaCardiac disorders | 0/83 | 3/84 |
| PneumoniaInfections and infestations | 2/83 | 0/84 |
| Atrial fibrillationCardiac disorders | 2/83 | 1/84 |
| Intestinal ischaemiaGastrointestinal disorders | 2/83 | 1/84 |
| HypotensionVascular disorders | 2/83 | 2/84 |
| Event | Gelatine | Electrolyte |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 15/83 | 15/84 |
| Acute kidney injuryRenal and urinary disorders | 10/83 | 6/84 |
| ThrombocytosisBlood and lymphatic system disorders | 4/83 | 10/84 |
| Atrial fibrillationCardiac disorders | 9/83 | 10/84 |
| HypernatraemiaMetabolism and nutrition disorders | 9/83 | 5/84 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 7/83 | 6/84 |
| ThrombocytopeniaBlood and lymphatic system disorders | 6/83 | 4/84 |
| HypokalaemiaMetabolism and nutrition disorders | 2/83 | 5/84 |
| DeliriumNervous system disorders | 3/83 | 5/84 |
| HypocalcaemiaMetabolism and nutrition disorders | 4/83 | 1/84 |
| Age, Categorical(Participants) | Gelatine | Electrolyte | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 29 | 34 | 63 |
| >=65 years | 54 | 50 | 104 |
| Age, Continuous(years) | Gelatine | Electrolyte | Total |
|---|---|---|---|
| Mean | 65.3 ± 14.20 | 65.9 ± 14.14 | 65.6 ± 14.13 |
| Sex: Female, Male(Participants) | Gelatine | Electrolyte | Total |
|---|---|---|---|
| Female | 21 | 20 | 41 |
| Male | 62 | 64 | 126 |
| Race (NIH/OMB)(Participants) | Gelatine | Electrolyte | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 82 | 83 | 165 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(participants) | Gelatine | Electrolyte | Total |
|---|---|---|---|
| Austria | 6 | 6 | 12 |
| Czechia | 10 | 9 | 19 |
| France | 0 | 2 | 2 |
| Germany | 59 | 61 | 120 |
| Spain | 8 | 6 | 14 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is terminated, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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