Acetated Ringer´s solution in experimental hypovolemia

Phase 1

Recruiting

• Conditions: Hypovolemia; MedDRA version: 20.1Level: LLTClassification code: 10021139Term: Hypovolemia Class: 10027433; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; Therapeutic area: Phenomena and Processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: CTIS2023-503946-30-00
• Lead Sponsor: Oslo University Hospital HF

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-02
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 12

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the duration of hemodynamic effect of bolus Ringer`s acetate;Secondary Objective: To assess the duration of volume effect of bolus Ringer`s acetate, To assess the duration of cerebrovascular effect of bolus Ringer`s acetate;Primary end point(s): Half-life of cardiac stroke volume relative to baseline

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Half-life of intravascular volume relative to baseline;Secondary end point(s):Half-life of MCAv integral relative to baseline