Hemodynamic parameters is to be investigated -- comparing cold fluids to body temperature fluids.
Conditions
Interventions
Trade Name: Ringer-laktat "Fresenius Kabi"
Product Name: Ringer-laktat
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: sodium, chloride, potassium, calcium, and lactate
CAS Number: 802
Sponsors
Hospital of South West Jutland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female and male subjects is recruited from healthy volunteers Inclusion criteria • Age between 18-64 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria • Pre-existing medical problems • Pregnancy (validated through a certified pregnancy test) • Body mass index >35 kg/m2 • Medication use apart from allergy medication, contraceptives, or non-steroidal anti-inflammatory drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This randomized controlled crossover study investigates the effect of Ringer's lactate solution at high and low temperatures on physiological response in healthy adults.;Secondary Objective: Not applicable;Primary end point(s): The primary outcome of the study is the increase in MAP at 15 minutes after infusion of the fluid bolus.;Timepoint(s) of evaluation of this end point: This endpoint is evaluated 15 min. after infusion of fluids (45 min after trial start) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary outcome is time until return of MAP to baseline value after infusion.;Timepoint(s) of evaluation of this end point: This endpoint is evaluated continuously throughout the 2-hour trial. | — |
Countries
Denmark
Contacts
Public ContactPeter Biesenbach
Hospital of South West Jutland
Outcome results
None listed