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HypovolemiaPhase 3NCT01515397

Comparison of Two Gelatine Solutions

A Phase 3 study testing Gelofusine balanced and Gelofusine 4% in people with Hypovolemia, run by B. Braun Melsungen AG at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of volume replacement is to compensate a reduction in the intravascular volume e.g. during surgery and to counteract hypovolemia in order to maintain hemodynamics and vital functions. To achieve this, different plasma substitutes are available: Albumin, dextran, hydroxyethylstarches and gelatine. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Hypovolemia
What is being tested?
Gelofusine balanced and Gelofusine 4%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesGermany
Study dates
Dec 2011to Jan 2013
Phase
Phase 3
Are there results?
None posted in the registry

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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients >= 18 years of age and <= 90 years of age. Women of child bearing potential must test negative on standard pregnancy test.
  • Patients scheduled to undergo elective abdominal surgery (e.g. Rectal resection, liver resection, open bowl resection, duodenopancreatectomy reconstitution).
  • Scheduled intraoperative volume requirement of at least 15 ml / kg body weight (BROCA) gelatine solution
  • Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Ethics Committee (IEC) prior to all evaluations.

Who cannot join

  • Patients of ASA-class > III
  • Known hypersensitivity to gelatine or to any of the constituents of the solution
  • Patients treated with other colloid solutions and / or blood products 24 hours prior to surgery
  • Patients on hemodialysis
  • Patients suffering from decompensated renal function (i.e. serum creatinine > 3.0 mg/dl)
  • Patients suffering from Hypervolemia Hyperhydration Severe blood coagulation disorders Hypernatremia (serum(Na+) > 150 mmol/L) Hyperchloremia (serum(Cl-) > 110 mmol/L)
Show all 10Show fewer
  • Estimated perioperative need for blood products of 3,5 ml / kg body weight (BROCA)
  • Lactation period
  • Simultaneous participation in another clinical trial
  • Emergencies

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Universitätsklinikum Aachen, Klinik für Anästhesiologie

    Aachen, 52074

  • Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Frankfurt/Main

    Frankfurt am Main, 60590

Other trials in Germany

About this study

Official title: Efficacy and Safety of a Balanced Gelatine Solution in Combination With a Balanced Electrolyte Solution Versus a Standard Gelatine Solution in Combination With a Non-balanced Electrolyte Solution in Patients Scheduled for Abdominal Surgery

The aim of volume replacement is to compensate a reduction in the intravascular volume e.g. during surgery and to counteract hypovolemia in order to maintain hemodynamics and vital functions. To achieve this, different plasma substitutes are available: Albumin, dextran, hydroxyethylstarches and gelatine. The aim of this study is to demonstrate that acid-base alterations during elective abdominal surgery can be reduced by the use of a new gelatine solution.

Conditions
Hypovolemia
Being tested
Gelofusine balanced, Gelofusine 4%
Medical subject headings
Hypovolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gelofusine balancedDrug

    Gelofusine balanced combined with Sterofundin ISO

  • Gelofusine 4%Drug

    Gelofusine 4% combined with NaCl 0.9%

Study groups in NCT01515397
Study groupRoleWhat they receive
balanced gelatine solutionExperimentalisotonic colloidal volume substitute
Receives: Drug: Gelofusine balanced
non-balanced gelatine solutionActive comparatorcolloidal volume substitute
Receives: Drug: Gelofusine 4%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. base excess [mmol/l]

    Measured: Change from baseline at end of surgery, an expected average of 2 hours surgery

  2. chloride [mmol/l]

    Measured: Change from baseline at end of surgery, an expected average of 2 hours surgery

Secondary outcomes (6)

  1. arterial blood gase analyses

    Measured: until 12 hours after surgery

  2. coagulation status

    Measured: until 12 hours after surgery

  3. renal function

    Measured: until 12 hours after surgery

  4. adverse events

    Measured: until 12 hours after surgery

  5. hemodynamics (systolic and diastolic blood pressure)

    Measured: until 12 hours after surgery

  6. time on ventilation

    Measured: until 12 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2012 (estimated)
  2. Study startDec 2011
  3. Primary completionJan 2013
  4. Study completionJan 2013

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01515397
Sponsor's protocol ID
HC-G-H-0904
Status last verified
Nov 2013
First submitted
2 Jan 2012
Last updated
27 Nov 2013
Results posted
No
Data monitoring committee
No

Publications

  • Marx G, Meybohm P, Schuerholz T, Lotz G, Ledinko M, Schindler AW, Rossaint R, Zacharowski K. Impact of a new balanced gelatine on electrolytes and pH in the perioperative care. PLoS One. 2019 Apr 29;14(4):e0213057. doi: 10.1371/journal.pone.0213057. eCollection 2019.

    PubMed 31034525

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gelofusine balanced and Gelofusine 4% in people with Hypovolemia, run by B. Braun Melsungen AG at 2 sites in Germany.

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 4 inclusion and 10 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: finished, as of the sponsor's last update on 27 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

base excess [mmol/l] (time frame: Change from baseline at end of surgery, an expected average of 2 hours surgery). The study lists 2 primary outcomes in all. 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 NCT01515397, 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 27 Nov 2013.

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