CTIS2023-503946-30-00
Recruiting
Phase 1
A randomized study to investigate central and cerebral hemodynamic effects and volume kinetics of Ringer´s Acetate compared with no intravenous fluids, during experimental hypovolemia compared with euvolemia, in healthy human volunteers.
Oslo University Hospital HF0 sites12 target enrollmentMarch 2, 2023
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hypovolemia
- Sponsor
- Oslo University Hospital HF
- Enrollment
- 12
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant must be 18 to 40 years of age inclusive, at the time of signing the informed consent, Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination and focused cardiac ultrasound, Female participants: Use of adequate birth control for women of childbearing potential, Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
Exclusion Criteria
- •Any medical condition limiting physical exertional capacity or requiring regular medication (allergy and contraceptives excepted), Pregnancy, Breastfeeding, History of syncope (syncope of presumed vasovagal nature with known precipitating factor excepted), Any known cardiac arrhythmia, Any drug (contraceptives excepted) used on a regular basis for a chronic condition (allergy excepted)
Outcomes
Primary Outcomes
Not specified
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