Gelatines in Pediatric PatientS

Completed

• Conditions: Treatment of Hypovolemia and Shock
• Interventions: Drug: Gelofusine 4%; Drug: Gelaspan 4%

• Registration Number: NCT02495285
• Lead Sponsor: B. Braun Melsungen AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-06-12
• Study First Submitted QC: 2015-07-10
• Study First Posted: 2015-07-13
• Primary Completion: 2020-05
• Study Completion: 2020-05
• Results First Submitted: 2023-02-09
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-15
• Last Update Submitted: 2024-10-15
• Results First Posted: 2024-12-04
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 601

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gelofusine 4%	Gelofusine 4%	Children age ≤ 12 years
Gelaspan 4%	Gelaspan 4%	Children age ≤ 12 years

Primary Outcome Measures

Name	Time	Method
Dosing of the Products During Surgery	Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions

Secondary Outcome Measures

Name	Time	Method
Potentia Hydrogenii	Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions	Potentia hydrogenii (ph) was part of blood sampling/laboratory to measure the levels of oxygen and carbon dioxide.
Hemoglobin	Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions	mmol/L
Lactate	Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions	mmol/l
Hematocrit	Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions	%
Glucose	Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions	mmol/l
Serum Prolin	Before (0 - 2 days) and up to 2 days after infusion of gelatin solutions	µmol/l
Serum Creatinine	Before (0 - 2 days) and up to 2 days after infusion of gelatin solutions	µmol/l
Number of Participants With (Serious) Adverse Events / Reactions	Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Heart Rate	Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions	beats per minute
Mean Arterial Pressure	Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions	mmHg
Follow-up Assessed by Number of Participants With Post-operative Complications	At discharge from the hospital or in-hospital 3 months after start of gelatine infusion, whatever occurs first.

Trial Locations

Locations (11)

National Cardiology Hospital; 🇧🇬 Sofia, Bulgaria

Auf der Bult; 🇩🇪 Hannover, Germany

Klinik Hallerwiese/Cnopf´sche Kinderklinik; 🇩🇪 Nuernberg, Germany

Ospedale dei Bambini Vittore Buzzi; 🇮🇹 Milano, Italy

Hospital de Sant Joan de Déu; 🇪🇸 Barcelona, Spain

Azienda Policlinico Universitaria G. Rodolico -Vittorio Emanuele; 🇮🇹 Catania, Italy

Vall d'Hebron University Hospital; 🇪🇸 Barcelona, Spain

Medizinische Hochschule Hannover, Pädiatrische Kardiologie und Intensivmedizin; 🇩🇪 Hannover, Germany

Klinikum Stuttgart, Olgahospital und Frauenklinik; 🇩🇪 Stuttgart, Germany

Alder Hey Children's NHS FT; 🇬🇧 Liverpool, United Kingdom

Hospital Son Espases; 🇪🇸 Palma De Mallorca, Spain