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Gelatines in Pediatric PatientS

NCT ID: NCT02495285

Last Updated: 2024-12-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

601 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2020-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Treatment of Hypovolemia and Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Gelofusine 4%

Children age ≤ 12 years

Gelofusine 4%

Intervention Type DRUG

Gelaspan 4%

Children age ≤ 12 years

Gelaspan 4%

Intervention Type DRUG

Interventions

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Gelofusine 4%

Intervention Type DRUG

Gelaspan 4%

Intervention Type DRUG

Eligibility Criteria

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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:

* 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.
Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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B. Braun Melsungen AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Sümpelmann, Prof.

Role: PRINCIPAL_INVESTIGATOR

Medizinische Hochschule Hannover (MHH)

Locations

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National Cardiology Hospital

Sofia, , Bulgaria

Site Status

Auf der Bult

Hanover, , Germany

Site Status

Medizinische Hochschule Hannover, Pädiatrische Kardiologie und Intensivmedizin

Hanover, , Germany

Site Status

Klinik Hallerwiese/Cnopf´sche Kinderklinik

Nuremberg, , Germany

Site Status

Klinikum Stuttgart, Olgahospital und Frauenklinik

Stuttgart, , Germany

Site Status

Azienda Policlinico Universitaria G. Rodolico -Vittorio Emanuele

Catania, , Italy

Site Status

Ospedale dei Bambini Vittore Buzzi

Milan, , Italy

Site Status

Hospital de Sant Joan de Déu

Barcelona, , Spain

Site Status

Vall d'Hebron University Hospital

Barcelona, , Spain

Site Status

Hospital Son Espases

Palma de Mallorca, , Spain

Site Status

Alder Hey Children's NHS FT

Liverpool, , United Kingdom

Site Status

Countries

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Bulgaria Germany Italy Spain United Kingdom

References

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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.

Reference Type DERIVED
PMID: 35588274 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HC-O-H-1406

Identifier Type: -

Identifier Source: org_study_id