Clinical trial NCT02495285: Gelatines in Pediatric PatientS
Official title: Infusion of Gelatine Solutions in Pediatric Patients Aged up to 12 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Treatment of Hypovolemia and Shock
Keywords: pediatric patients gelatine
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2015-07-13
Enrollment: 601
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children

Brief 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.


Eligibility criteria: Inclusion:

* 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:

* 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.

Primary outcomes:
measure: Dosing of the Products During Surgery
timeFrame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Secondary outcomes:
measure: Potentia Hydrogenii
timeFrame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
measure: Hemoglobin
timeFrame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
measure: Lactate
timeFrame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
measure: Hematocrit
timeFrame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
measure: Glucose
timeFrame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
measure: Serum Prolin
timeFrame: Before (0 - 2 days) and up to 2 days after infusion of gelatin solutions
measure: Serum Creatinine
timeFrame: Before (0 - 2 days) and up to 2 days after infusion of gelatin solutions
measure: Number of Participants With (Serious) Adverse Events / Reactions
timeFrame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
measure: Heart Rate
timeFrame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
measure: Mean Arterial Pressure
timeFrame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
measure: Follow-up Assessed by Number of Participants With Post-operative Complications
timeFrame: At discharge from the hospital or in-hospital 3 months after start of gelatine infusion, whatever occurs first.
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: National Cardiology Hospital
city: Hannover
country: Germany
facility: Auf der Bult
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Pädiatrische Kardiologie und Intensivmedizin
city: Nuernberg
country: Germany
facility: Klinik Hallerwiese/Cnopf´sche Kinderklinik
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart, Olgahospital und Frauenklinik
city: Catania
country: Italy
facility: Azienda Policlinico Universitaria G. Rodolico -Vittorio Emanuele
city: Milano
country: Italy
facility: Ospedale dei Bambini Vittore Buzzi
city: Barcelona
country: Spain
facility: Hospital de Sant Joan de Déu
city: Barcelona
country: Spain
facility: Vall d'Hebron University Hospital
city: Palma De Mallorca
country: Spain
facility: Hospital Son Espases
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's NHS FT
Study officials:
affiliation: Medizinische Hochschule Hannover (MHH)
name: Robert Sümpelmann, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.