Gelatines in Pediatric PatientS

Treatment of Hypovolemia and Shock Clinical Trial

— GPS  

Official title:

Infusion of Gelatine Solutions in Pediatric Patients Aged up to 12 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02495285
• Other study ID #: HC-O-H-1406
• Status: Completed
• Start date: May 2015
• Est. completion date: May 2020

Study information

• Verified date: July 2020
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypovolemia
• Treatment of Hypovolemia and Shock

Intervention

Drug:
• Gelofusine 4%

• Gelaspan 4%

Locations

Country	Name	City	State
Bulgaria	National Cardiology Hospital	Sofia
Germany	Auf der Bult	Hannover
Germany	Medizinische Hochschule Hannover, Pädiatrische Kardiologie und Intensivmedizin	Hannover
Germany	Klinik Hallerwiese/Cnopf´sche Kinderklinik	Nuernberg
Germany	Klinikum Stuttgart, Olgahospital und Frauenklinik	Stuttgart
Italy	Azienda Policlinico Universitaria G. Rodolico -Vittorio Emanuele	Catania
Italy	Ospedale dei Bambini Vittore Buzzi	Milano
Spain	Hospital de Sant Joan de Déu	Barcelona
Spain	Vall d'Hebron University Hospital	Barcelona
Spain	Hospital Son Espases	Palma De Mallorca
United Kingdom	Alder Hey Children's NHS FT	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Melsungen AG

Countries where clinical trial is conducted

Bulgaria,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosing of the products during surgery		Observation period will start 2 hours prior first infusion of gelatine solutions and will end 2 hours after the last gelatine infusion stopped.
Secondary	Potentia hydrogenii		Observation period will start 2 hours prior first infusion of gelatine solutions and will end 2 hours after the last gelatine infusion stopped.
Secondary	Hemoglobin	g/dl	Observation period will start 2 hours prior first infusion of gelatine solutions and will end 2 hours after the last gelatine infusion stopped.
Secondary	Lactate	mmol/l	Observation period will start 2 hours prior first infusion of gelatine solutions and will end 2 hours after the last gelatine infusion stopped.
Secondary	Hematocrit		Observation period will start 2 hours prior first infusion of gelatine solutions and will end 2 hours after the last gelatine infusion stopped.
Secondary	Glucose	mmol/l	Observation period will start 2 hours prior first infusion of gelatine solutions and will end 2 hours after the last gelatine infusion stopped.
Secondary	Serum prolin	µmol/l	Observation period will start 2 hours prior first infusion of gelatine solutions and will end 2 hours after the last gelatine infusion stopped.
Secondary	Serum creatinine	mg/dl	Observation period will start 2 hours prior first infusion of gelatine solutions and will end 2 hours after the last gelatine infusion stopped.
Secondary	Number of (Serious) adverse events / reactions		Observation period will start 2 hours prior first infusion of gelatine solutions and will end 2 hours after the last gelatine infusion stopped.
Secondary	Heart rate	beats per minute	Observation period will start 2 hours prior first infusion of gelatine solutions and will end 2 hours after the last gelatine infusion stopped.
Secondary	Mean arterial pressure	mmHg	Observation period will start 2 hours prior first infusion of gelatine solutions and will end 2 hours after the last gelatine infusion stopped.
Secondary	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.