Effects of Acetated Ringer's Solution on Blood Volume in Healthy Volunteers

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

This study is testing how a special fluid called Acetated Ringer's Solution affects blood volume and heart function in healthy volunteers.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 40 Years
• Sex: All
• Sponsor: Oslo University Hospital (Academic / other)
• Locations: 1 site (Oslo)
• Trial ID: NCT05705115 on ClinicalTrials.gov

What this trial studies

This study investigates the hemodynamic effects of administering Acetated Ringer's Solution during both normovolemia and hypovolemia in healthy volunteers. It aims to measure how intravenous fluid administration impacts stroke volume and other hemodynamic variables over time, particularly focusing on the transient nature of these effects. Participants will undergo two visits, each lasting approximately two hours, with a follow-up visit, and a maximum of 15 participants will be enrolled to ensure that 12 evaluable participants complete the study. The study will utilize hemoglobin concentration measurements to calculate the volume-expanding effects of the fluid bolus.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults who can provide informed consent and meet specific medical evaluation criteria.

Not a fit: Patients with underlying health conditions or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of fluid management in clinical settings, potentially leading to improved treatment strategies for patients experiencing hypovolemia.

How similar studies have performed: While the approach of studying fluid responsiveness is established, this specific investigation into the transient effects of Acetated Ringer's Solution in healthy volunteers is relatively novel.

Eligibility 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).

Where this trial is running

Oslo

• Oslo University Hospital — Oslo, Norway (Recruiting)

Conditions Hypovolemia; Fluid Loss; Hemodynamic Instability