Gelatines in Pediatric PatientS (GPS)

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

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.

Study Overview

• Status: Completed
• Conditions: Treatment of Hypovolemia and Shock
• Intervention / Treatment: Drug: Gelofusine 4%; Drug: Gelaspan 4%

• Study Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

children

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Gelofusine 4%; Children age ≤ 12 years	Drug: Gelofusine 4%
Gelaspan 4%; Children age ≤ 12 years	Drug: Gelaspan 4%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
Hematocrit		Observation period will start 2 hours prior first infusion of gelatine solutions and will end 2 hours after the last gelatine infusion stopped.
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.
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: B. Braun Melsungen AG
• Investigators: Principal Investigator: Robert Sümpelmann, Prof., Medizinische Hochschule Hannover (MHH)

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: June 12, 2015
• First Submitted That Met QC Criteria: July 10, 2015
• First Posted (Estimate): July 13, 2015

Study Record Updates

• Last Update Posted (Actual): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 9, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: pediatric patients gelatine
• Additional Relevant MeSH Terms: Pathologic Processes; Hypovolemia; Plasma Substitutes; Blood Substitutes; Polygeline
• Other Study ID Numbers: HC-O-H-1406