Treatment of Hypovolemia and ShockGPSNCT02495285
Gelatines in Pediatric PatientS
An observational study of Treatment of Hypovolemia and Shock, run by B. Braun Melsungen AG at 11 sites in 5 countries.
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. So far, there is only few data on the safety and efficacy of the products under investigation in children. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Treatment of Hypovolemia and Shock
- What is being tested?
- Gelofusine 4% and Gelaspan 4%
- How many people
- 601 participants
- Where
- 11 sitesin 5 countries
- Study dates
- May 2015to May 2020
- Phase
- Observational
- 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 Up to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: children
Who may be able to join
- Age ≤ 12 years
- American Society of Anesthesiologists (ASA) risk score: ≤ III
- Peri-operative infusion of gelatine solutions
- Informed consent and/or data protection declaration signed by parents/legal guardians (according to local requirements)
Who cannot join
- Inclusion in another investigational study in the field of volume replacement which could interfere with the routine clinical practice regarding the administration of the gelatine solutions
- In addition contraindications as outlined in the valid local Summaries of Product Characteristics (SmPCs) have to be considered.
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
Germany4 sites
Auf der Bult
Hanover, 30173
Medizinische Hochschule Hannover, Pädiatrische Kardiologie und Intensivmedizin
Hanover, 30625
Klinik Hallerwiese/Cnopf´sche Kinderklinik
Nuremberg, 90419
Klinikum Stuttgart, Olgahospital und Frauenklinik
Stuttgart, 70174
Spain3 sites
Hospital de Sant Joan de Déu
Barcelona
Vall d'Hebron University Hospital
Barcelona
Hospital Son Espases
Palma de Mallorca
Italy2 sites
Azienda Policlinico Universitaria G. Rodolico -Vittorio Emanuele
Catania, I-95100
Ospedale dei Bambini Vittore Buzzi
Milan, I-20154
About this study
Official title: Infusion of Gelatine Solutions in Pediatric Patients Aged up to 12 Years
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. So far, there is only few data on the safety and efficacy of the products under investigation in children.
The primary aim of this non-interventional observational study (NIS) is to collect further data of gelatine solutions in a large pediatric population during routine clinical practice.
- Conditions
- Treatment of Hypovolemia and Shock
- Being tested
- Gelofusine 4%, Gelaspan 4%
- Keywords
- pediatric patients gelatine
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gelofusine 4%Drug
Gelaspan 4%Drug
| Study group | Role | What they receive |
|---|---|---|
| Gelofusine 4% | Children age ≤ 12 years Receives: Drug: Gelofusine 4% | |
| Gelaspan 4% | Children age ≤ 12 years Receives: Drug: Gelaspan 4% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosing of the Products During Surgery
Measured: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Secondary outcomes (11)
Potentia Hydrogenii
Potentia hydrogenii (ph) was part of blood sampling/laboratory to measure the levels of oxygen and carbon dioxide.
Measured: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Hemoglobin
mmol/L
Measured: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Lactate
mmol/l
Measured: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Hematocrit
%
Measured: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Glucose
mmol/l
Measured: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Serum Prolin
µmol/l
Measured: Before (0 - 2 days) and up to 2 days after infusion of gelatin solutions
Serum Creatinine
µmol/l
Measured: Before (0 - 2 days) and up to 2 days after infusion of gelatin solutions
Number of Participants With (Serious) Adverse Events / Reactions
Measured: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Heart Rate
beats per minute
Measured: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Mean Arterial Pressure
mmHg
Measured: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Follow-up Assessed by Number of Participants With Post-operative Complications
Measured: At discharge from the hospital or in-hospital 3 months after start of gelatine infusion, whatever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2020
- Study completionMay 2020
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 Treatment of Hypovolemia and ShockStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 601 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Sümpelmann, Prof., Principal investigator, Medizinische Hochschule Hannover (MHH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495285
- Sponsor's protocol ID
- HC-O-H-1406
- Acronym
- GPS
- Status last verified
- Oct 2024
- First submitted
- 12 Jun 2015
- Last updated
- 4 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rudolf D, Witt L, Boethig D, Rigterink V, Zander R, Sumpelmann R, Dennhardt N. The impact of modified fluid gelatin 4% in a balanced electrolyte solution on plasma osmolality in children-A noninterventional observational study. Paediatr Anaesth. 2022 Aug;32(8):961-966. doi: 10.1111/pan.14494. Epub 2022 May 31.
PubMed 35588274
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infusion of Gelatine Solutions in Pediatric Patients Aged up to 12 Years
- ClinicalTrials.gov ID
- NCT02495285
- Acronym / sponsor ID
- GPS / HC-O-H-1406
- Conditions
- Treatment of Hypovolemia and Shock
- Keywords
- pediatric patients gelatine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- May 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 13 Jul 2015 (estimated)
- Results
- Posted 4 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. So far, there is only few data on the safety and efficacy of the products under investigation in children.
The primary aim of this non-interventional observational study (NIS) is to collect further data of gelatine solutions in a large pediatric population during routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gelofusine 4% | – | Drug: Gelofusine 4%Children age ≤ 12 years |
| Gelaspan 4% | – | Drug: Gelaspan 4%Children age ≤ 12 years |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children
Key inclusion criteria (4 listed)
- Age ≤ 12 years
- American Society of Anesthesiologists (ASA) risk score: ≤ III
- Peri-operative infusion of gelatine solutions
- Informed consent and/or data protection declaration signed by parents/legal guardians (according to local requirements)
Key exclusion criteria (2 listed)
- Inclusion in another investigational study in the field of volume replacement which could interfere with the routine clinical practice regarding the administration of the gelatine solutions
- In addition contraindications as outlined in the valid local Summaries of Product Characteristics (SmPCs) have to be considered.
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 |
|---|---|---|
| Gelofusine 4% | Drug | Gelofusine 4% |
| Gelaspan 4% | Drug | Gelaspan 4% |
Primary outcome
Dosing of the Products During Surgery
Time frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
11 secondary outcomes
Potentia Hydrogenii
Time frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Hemoglobin
Time frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Lactate
Time frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Hematocrit
Time frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Glucose
Time frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Serum Prolin
Time frame: Before (0 - 2 days) and up to 2 days after infusion of gelatin solutions
Serum Creatinine
Time frame: Before (0 - 2 days) and up to 2 days after infusion of gelatin solutions
Number of Participants With (Serious) Adverse Events / Reactions
Time frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Heart Rate
Time frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Mean Arterial Pressure
Time frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Follow-up Assessed by Number of Participants With Post-operative Complications
Time frame: At discharge from the hospital or in-hospital 3 months after start of gelatine infusion, whatever occurs first.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35588274Rudolf D, Witt L, Boethig D, Rigterink V, Zander R, Sumpelmann R, Dennhardt N. The impact of modified fluid gelatin 4% in a balanced electrolyte solution on plasma osmolality in children-A noninterventional observational study. Paediatr Anaesth. 2022 Aug;32(8):961-966. doi: 10.1111/pan.14494. Epub 2022 May 31.
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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.
Robert Sümpelmann, Prof. principal investigator
Medizinische Hochschule Hannover (MHH)
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Treatment of Hypovolemia and Shock, run by B. Braun Melsungen AG at 11 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 4 inclusion and 2 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 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, Spain, Italy, Bulgaria, United Kingdom. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Dec 2024). 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?
Dosing of the Products During Surgery (time frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions). 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 NCT02495285, 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 4 Dec 2024.