Anaesthesia
Conditions
Interventions
Trade Name: Sterofundin ISO
Product Name: Sterofundin ISO
Product Code: PL 03551/0100
Pharmaceutical Form: Infusion
INN or Proposed INN:
Sponsors
None listed
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: The following inclusion criteria apply to this study: • Male volunteers between the age of 18 and 40 years. • Body weight between 65 and 80 kg. • Able to give written informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: The following exclusion criteria apply to this study • Any chronic medical condition or acute illness in the six-week period preceding the study. • SmPC contraindication: known hypersensitivity to the active substance. • Subjects on regular medication. • Subjects with history of substance abuse. • Subjects with abnormal baseline laboratory values.- Where abnormal laboratory values are reported on baseline assessment, subjects will be excluded from the study and a letter will be sent to their General practitioner detailing their laboratory results. The General Practitioner will act accordingly. In the case where the laboratory values warrant urgent medical intervention, the participant will be referred to the Emergency Department at the Queens Medical Centre, Nottingham for appropriate care. • Individuals with personal or religious beliefs that prohibit the consumption of bovine products may not wish to participate in the study as Gelaspan contains bovine gelatine • Those individuals with a contraindication to MRI scanning: o Metal implants o Aneurysm clips o Pacemaker or artificial heart valves o Cochlear implants o Claustrophobia o Tattoos
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the differential impact of isovolumetric and isoeffective infusions of crystalloid and gelatin on blood volume expansion.; Secondary Objective: The secondary objectives of this study are: •To determine the differential impact of isovolumetric and isoeffective infusions of crystalloid and gelatin on cardiac output and renal, coronary and aortic artery blood flow and velocity as well as renal venous flow and velocity as measured by MRI •To compare serum electrolyte concentrations in the 4 hours post-infusion •To measure electrolyte and water excretion over the same period. ;Primary end point(s): The primary end point of this study will be to determine the differential impact of isovolumetric and isoeffective infusions of crystalloid and gelatin on blood volume after infusion of the solutions in ml.; Timepoint(s) of evaluation of this end point: this will b e done at times 0, 60, 90, 120, 180 and 240 minutes after the start of the infusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To determine the differential impact of isovolumetric and isoeffective infusions of crystalloid and gelatin on cardiac output and renal, coronary and aortic artery blood flow and velocity as well as renal venous flow and velocity as measured by MRI; • To compare serum electrolyte concentrations in the 6 hours post-infusion; and • To measure electrolyte and water excretion over the same period. ;Timepoint(s) of evaluation of this end point: MRI scanning of the kidney and the heart will be performed at Times 0, 20, 40 and 60 minutes after the start of the infusion | — |
Countries
United Kingdom
Contacts
Public ContactShone
University of Nottingham
Outcome results
None listed