Gelatines in Pediatric PatientS

Study Overview
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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.

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

Conditions
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Treatment of Hypovolemia and Shock

Intervention / Treatment
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* Drug: Gelofusine 4%
* Drug: Gelaspan 4%


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gelofusine 4%<br>Children age ≤ 12 years | Drug: Gelofusine 4%<br> <br> |
| Gelaspan 4%<br>Children age ≤ 12 years | Drug: Gelaspan 4%<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric patients gelatine