CClinicalTrials.gg
Sign In
CompletedNCT02495285GPSUpdated Dec 4, 2024Results posted

Gelatines in Pediatric PatientS

An observational study in Treatment of Hypovolemia and Shock, sponsored by B. Braun Melsungen AG. Completed at 11 sites in 5 countries. Open to participants aged Up to 12 Years. Per ClinicalTrials.gov, last updated 2024-12-04.

Sponsored by B. Braun Melsungen AG · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
601
Ages
Up to 12 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Treatment of Hypovolemia and Shock

Browse trials for

Keywords

  • pediatric patients gelatine
03

Who can participate

Ages eligible
Up to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

children

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion:

  • 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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
601 participants (actual)

Groups and cohorts

  • Gelofusine 4%

    Children age ≤ 12 years

    Drug: Gelofusine 4%

  • Gelaspan 4%

    Children age ≤ 12 years

    Drug: Gelaspan 4%

Interventions

  • DrugGelofusine 4%
  • DrugGelaspan 4%
05

What researchers measure

Primary outcomes

  1. Dosing of the Products During Surgery

    Time frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions

Secondary outcomes

  1. Potentia Hydrogenii

    Potentia hydrogenii (ph) was part of blood sampling/laboratory to measure the levels of oxygen and carbon dioxide.

    Time frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions

  2. Hemoglobin

    mmol/L

    Time frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions

  3. Lactate

    mmol/l

    Time frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions

  4. Hematocrit

    %

    Time frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions

  5. Glucose

    mmol/l

    Time frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions

  6. Serum Prolin

    µmol/l

    Time frame: Before (0 - 2 days) and up to 2 days after infusion of gelatin solutions

  7. Serum Creatinine

    µmol/l

    Time frame: Before (0 - 2 days) and up to 2 days after infusion of gelatin solutions

  8. Number of Participants With (Serious) Adverse Events / Reactions

    Time frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions

  9. Heart Rate

    beats per minute

    Time frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions

  10. Mean Arterial Pressure

    mmHg

    Time frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions

  11. 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.

06

Results

Posted Dec 4, 2024

Participant flow

Participant flow — Overall Study
MilestoneGelofusine 4%Gelaspan 4%
Started121480
Completed121480
Not completed00

Outcome measures

PrimaryDosing of the Products During Surgery
Time frame:
Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Reported as:
Mean · ml/kg
Dosing of the Products During Surgery
ml/kgGelofusine 4%Gelaspan 4%
Dosing of the Products During Surgery14.58 ± 6.8512.64 ± 4.72
SecondaryPotentia Hydrogenii

Potentia hydrogenii (ph) was part of blood sampling/laboratory to measure the levels of oxygen and carbon dioxide.

Time frame:
Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Reported as:
Mean · unitless
Potentia Hydrogenii
unitlessGelofusine 4%Gelaspan 4%
Before Infusion7.35 ± 0.087.34 ± 0.06
After Infusion7.34 ± 0.077.32 ± 0.07
SecondaryHemoglobin

mmol/L

Time frame:
Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Reported as:
Mean · mmol/L
Hemoglobin
mmol/LGelofusine 4%Gelaspan 4%
Before Infusion11.02 ± 2.5111.35 ± 2.22
After infusion10.01 ± 2.4210.30 ± 2.16
SecondaryLactate

mmol/l

Time frame:
Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Reported as:
Mean · mmol/l
Lactate
mmol/lGelofusine 4%Gelaspan 4%
Before infusion1.38 ± 0.801.19 ± 0.62
After infusion1.48 ± 0.871.30 ± 0.82
SecondaryHematocrit

%

Time frame:
Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Reported as:
Mean · "%"
Hematocrit
"%"Gelofusine 4%Gelaspan 4%
Before infusion35.33 ± 6.7635.06 ± 6.92
After infusion31.67 ± 7.6432.07 ± 7.12
SecondaryGlucose

mmol/l

Time frame:
Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Reported as:
Mean · mmol/l
Glucose
mmol/lGelofusine 4%Gelaspan 4%
Before infusion6.13 ± 3.025.21 ± 1.18
After infusion6.83 ± 4.366.61 ± 1.96
SecondarySerum Prolin

µmol/l

Time frame:
Before (0 - 2 days) and up to 2 days after infusion of gelatin solutions
Reported as:
Mean · µmol/l
Serum Prolin
µmol/lGelofusine 4%Gelaspan 4%
Before infusion235.25 ± 2.5—
After infusion180 ± 43.63—
SecondarySerum Creatinine

µmol/l

Time frame:
Before (0 - 2 days) and up to 2 days after infusion of gelatin solutions
Reported as:
Mean · µmol/l
Serum Creatinine
µmol/lGelofusine 4%Gelaspan 4%
Before infusion30.92 ± 15.3231.08 ± 16.48
After infusion30.23 ± 14.0633.13 ± 17.80
SecondaryNumber of Participants With (Serious) Adverse Events / Reactions
Time frame:
Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Reported as:
Count of participants · Participants
Number of Participants With (Serious) Adverse Events / Reactions
ParticipantsGelofusine 4%Gelaspan 4%
Number of Participants With (Serious) Adverse Events / Reactions14
SecondaryHeart Rate

beats per minute

Time frame:
Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Reported as:
Mean · beats per minute
Heart Rate
beats per minuteGelofusine 4%Gelaspan 4%
Before infusion116.74 ± 25.72121.20 ± 22.54
After infusion113.24 ± 22.54118.72 ± 21.88
SecondaryMean Arterial Pressure

mmHg

Time frame:
Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Reported as:
Mean · mmHg
Mean Arterial Pressure
mmHgGelofusine 4%Gelaspan 4%
Before infusion58.03 ± 14.8146.72 ± 11.54
After infusion65.23 ± 14.4855.55 ± 11.25
SecondaryFollow-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.
Reported as:
Count of participants · Participants
Follow-up Assessed by Number of Participants With Post-operative Complications
ParticipantsGelofusine 4%Gelaspan 4%
Follow-up Assessed by Number of Participants With Post-operative Complications04

Adverse events

Collected over Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Gelofusine 4%0/121 (0%)0/121 (0%)1/121 (0.8%)
Gelaspan 4%0/480 (0%)1/480 (0.2%)3/480 (0.6%)
Most frequent serious events
Most frequent serious events
EventGelofusine 4%Gelaspan 4%
Procedural hemorrhageInjury, poisoning and procedural complications0/1211/480
Most frequent other events
Most frequent other events
EventGelofusine 4%Gelaspan 4%
Procedural nauseaInjury, poisoning and procedural complications1/1210/480
HaemorrhageVascular disorders1/1211/480
Electrolyte imblanceMetabolism and nutrition disorders0/1211/480
HemodilutionInjury, poisoning and procedural complications0/1211/480

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Gelofusine 4%Gelaspan 4%Total
<=18 years121480601
Between 18 and 65 years000
>=65 years000
Age, Continuous
Age, Continuous(months)Gelofusine 4%Gelaspan 4%Total
Mean52.6 ± 45.7023.15 ± 34.1229.08 ± 38.55
Sex: Female, Male
Sex: Female, Male(Participants)Gelofusine 4%Gelaspan 4%Total
Female46203249
Male75277352
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Gelofusine 4%Gelaspan 4%Total
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Gelofusine 4%Gelaspan 4%Total
Italy53659
United Kingdom808
Bulgaria30030
Germany20431451
Spain104353
07

Study locations

11 sites
  • National Cardiology Hospital
    Sofia, 1606, Bulgaria
  • Auf der Bult
    Hannover, 30173, Germany
  • Medizinische Hochschule Hannover, Pädiatrische Kardiologie und Intensivmedizin
    Hannover, 30625, Germany
  • Klinik Hallerwiese/Cnopf´sche Kinderklinik
    Nuernberg, 90419, Germany
  • Klinikum Stuttgart, Olgahospital und Frauenklinik
    Stuttgart, 70174, Germany
  • Azienda Policlinico Universitaria G. Rodolico -Vittorio Emanuele
    Catania, I-95100, Italy
  • Ospedale dei Bambini Vittore Buzzi
    Milano, I-20154, Italy
  • Hospital de Sant Joan de Déu
    Barcelona, Spain
  • Vall d'Hebron University Hospital
    Barcelona, Spain
  • Hospital Son Espases
    Palma De Mallorca, Spain
  • Alder Hey Children's NHS FT
    Liverpool, L12 2AP, United Kingdom
08

References and documents

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 documents

  • Protocol and statistical analysis plan · Mar 13, 2019

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT02495285
Lead sponsor
B. Braun Melsungen AG
Responsible party
Sponsor
First posted
Jul 13, 2015
Start date
May 2015
Primary completion
May 2020
Completion
May 2020
Results posted
Dec 4, 2024
Last update
Dec 4, 2024

Study contacts

Robert Sümpelmann, Prof.
principal investigator · Medizinische Hochschule Hannover (MHH)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hypovolemia→

Other studies from this sponsor

B. Braun Melsungen AG

Start the discussion