Acetated Ringer´s Solution in Experimental Hypovolemia

• Status: Not yet recruiting
• Trial end date: 2024-07-29
• Target enrollment: 0
• Participant gender: All

Summary

Intravenous fluids are often given to increase stroke volume and thereby improve global oxygen delivery. The effect is however often transient, but the effect of a fluid bolus on stroke volume and other hemodynamic variables over time are poorly described. The volume effect of a fluid bolus (effect on blood volume) can be calculated by measuring Haemoglobin. The purpose of this study is to elucidate the hemodynamic effects of a fluid bolus during normovolemia and hypovolemia in healthy volunteers. Study details include:

• Study Duration: 2 visits of approximately 2 h duration each + follow-up visit. Visits 1 and 2 are at least 2 days apart. Number of Participants: A maximum of 15 participants will be enrolled to study intervention such that 12 evaluable participants complete the study

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oslo University Hospital
• Collaborator: University Hospital, Akershus

Criteria

Inclusion Criteria:

• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination and focused cardiac ultrasound

• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

• Sex and Contraceptive/Barrier Requirements Male participants: Not applicable. Female participants: Use of adequate birth control for women of childbearing potential.

• A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile when sexually active. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.

• Inclusion of WOCBP is possible when either:

• Using at least an acceptable effective contraceptive measure (combined (estrogen and progestogen containing) hormonal contraception, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence). As a minimum contraception should be maintained until treatment discontinuation. or

• Confirmed negative highly sensitive urine or serum pregnancy test at screening. A pregnancy test is performed at any visit before administering IMP if more than 14 days have passed since last pregnancy test. There will be no demand for post-intervention contraception.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

Medical Conditions

1. Any medical condition limiting physical exertional capacity or requiring regular medication (allergy and contraceptives excepted).

2. Pregnancy.

3. Breastfeeding.

4. History of syncope (syncope of presumed vasovagal nature with known precipitating factor excepted).

5. Any known cardiac arrhythmia. Prior/Concomitant Therapy

6. Any drug (contraceptives excepted) used on a regular basis for a chronic condition (allergy excepted).