E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
Denna studie kommer göras i ett crossoverformat och utforska skillnaden i hemodynamiskt svar mellan en varm och kall vätskebolus. Detta kommer att ge data relevant för andra populationer och studier (hypotoni, sepsis etc) men forskningspersonerna kommer inte ha några medicinska tillstånd. |
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E.1.1.1 | Medical condition in easily understood language |
Intravenous fluid is often given during surgery or critical illness. Our study will compare the difference between warm and cold fluid regarding cardiac function, blood pressure etc. |
Vätska ges ofta intravenöst under operation eller till svårt sjuka patienter. Vår studie kommer att jämföra skillnaden mellan varm och kall vätska avseende hjärtfunktion, blodtryck etc. hos friska |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the difference in cardiac output between the two groups |
Att finna skillnaden i hjärtminutvolym mellan de två grupperna |
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E.2.2 | Secondary objectives of the trial |
To determine the difference in blood pressure, microcirculation, temperature and duration of these effects |
Skillnaden i blodtryck, mikrocirkulation, temperatur och hur länge skillnaderna hålller i sig |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Healthy volunteers |
Friska forskningspersoner |
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E.4 | Principal exclusion criteria |
Medical disease corresponding to American Society of Anaesthesiology grade II or more |
Sjuklighet motsvarande American Society of Anaesthesiology klass II eller mer |
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E.5 End points |
E.5.1 | Primary end point(s) |
Cardiac output |
Hjärtminutvolym |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Pulse, blood pressure and temperature changes as well as functional microvessel density. Duration of these |
Puls. blodtryck, temperatur och småkärlsdensitet. Duration av dessa förändringar |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
30, 60 90 and 120 minutes |
30, 60, 90 och 120 minuter |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
The influence of temperature on the physiologic response |
Inflytandet av temperatur på det fysiologiska svaret. |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Same fluid with different temperature |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Planned recruitment of 21 healthy volunteers. The study will be concluded when 21 patients have been recruited and passed through both trial arms. |
Planerad rekrytering av 21 friska forskningspersoner. Studien avslutas när 21 patienter rekryterats och genomgått båda armarna av crossoverstudien |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |