Effect of warm and cold fluid therapy
Phase 1
- Conditions
- This trial will be a crossover study of healthy volunteers receiving a warm vs a cold fluid bolus to investigate the difference in hemodynamic response. While this will generate data for future studies in other categories (hypotension, sepsis etc), the volunteers will have no medical conditions.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2016-002548-18-SE
- Lead Sponsor
- Karolinska Institutet Södersjukhuset
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Healthy volunteers
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 21
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
Medical disease corresponding to American Society of Anaesthesiology grade II or more
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the difference in cardiac output between the two groups;Secondary Objective: To determine the difference in blood pressure, microcirculation, temperature and duration of these effects;Primary end point(s): Cardiac output;Timepoint(s) of evaluation of this end point: 15 minutes
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Pulse, blood pressure and temperature changes as well as functional microvessel density. Duration of these;Timepoint(s) of evaluation of this end point: 30, 60 90 and 120 minutes