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Completed

NCT Number: NCT02495285

Gelatines in Pediatric PatientS

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.

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Key information

Conditions

Treatment of Hypovolemia and Shock Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

Up to 12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cardiology Hospital, Sofia, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gelofusine 4%

Drug

Gelaspan 4%

Drug

Primary outcomes

  1. Dosing of the Products During Surgery

    Time frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions

Secondary outcomes

  1. Potentia Hydrogenii

    Time frame: 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.

  2. Hemoglobin

    Time frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions

    mmol/L

  3. Lactate

    Time frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions

    mmol/l

  4. Hematocrit

    Time frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions

    %

  5. Glucose

    Time frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions

    mmol/l

  6. Serum Prolin

    Time frame: Before (0 - 2 days) and up to 2 days after infusion of gelatin solutions

    µmol/l

  7. Serum Creatinine

    Time frame: Before (0 - 2 days) and up to 2 days after infusion of gelatin solutions

    µmol/l

  8. Number of Participants With (Serious) Adverse Events / Reactions

    Time frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions

  9. Heart Rate

    Time frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions

    beats per minute

  10. Mean Arterial Pressure

    Time frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions

    mmHg

  11. Follow-up Assessed by Number of Participants With Post-operative Complications

    Time frame: At discharge from the hospital or in-hospital 3 months after start of gelatine infusion, whatever occurs first.

Sponsors and collaborators

Lead sponsor

B. Braun Melsungen AG

Industry

Registry information

Official study title

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

Acronym: GPS

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jul 13, 2015
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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