N/A
Completed N=601
Gelatines in Pediatric PatientS
Treatment of Hypovolemia and Shock
Source: ClinicalTrials.gov NCT02495285 ↗
Enrolled (actual)
601
Serious AEs
0.2%
Results posted
Dec 2024
Primary outcomePrimary: Dosing of the Products During Surgery — 14.58; 12.64 ml/kg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dosing of the Products During Surgery |
14.58; 12.64 | — |
| SECONDARY Potentia Hydrogenii |
7.35; 7.34; 7.34; 7.32 | — |
| SECONDARY Hemoglobin |
11.02; 11.35; 10.01; 10.30 | — |
| SECONDARY Lactate |
1.38; 1.19; 1.48; 1.30 | — |
| SECONDARY Hematocrit |
35.33; 35.06; 31.67; 32.07 | — |
| SECONDARY Glucose |
6.13; 5.21; 6.83; 6.61 | — |
| SECONDARY Serum Prolin |
235.25; 180 | — |
| SECONDARY Serum Creatinine |
30.92; 31.08; 30.23; 33.13 | — |
| SECONDARY Number of Participants With (Serious) Adverse Events / Reactions |
1; 4 | — |
| SECONDARY Heart Rate |
116.74; 121.20; 113.24; 118.72 | — |
| SECONDARY Mean Arterial Pressure |
58.03; 46.72; 65.23; 55.55 | — |
| SECONDARY Follow-up Assessed by Number of Participants With Post-operative Complications |
0; 4 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02495285). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.