Acetated Ringer´s Solution in Experimental Hypovolemia

NCT05705115 | Recruiting Phase 4

• 1 other identifier: Volu-Flow
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hypovolemia; Fluid Loss; Hemodynamic Instability

Outcome Measures

Primary Outcomes (1)

• Cardiac stroke volume

  Half-life of change in cardiac stroke volume

  120 minutes

Secondary Outcomes (2)

• Intravascular volume

  120 minutes

• Middle cerebral artery blood flow velocity

  120 minutes

Other Outcomes (1)

• Hemodynamic response

  120 minutes

Study Arms (4)

LBNP 0 + no intravenous fluid

NO INTERVENTION

LBNP 0 + Ringer's acetate

EXPERIMENTAL

Drug: Ringer acetate

LBNP 40 + no intravenous fluid

ACTIVE COMPARATOR

Other: Lower body negative pressure

LBNP 40 + Ringer's acetate

EXPERIMENTAL

Drug: Ringer acetate; Other: Lower body negative pressure

Interventions

Ringer acetate DRUG

Ringer acetate 5 ml/kg.

LBNP 0 + Ringer's acetate; LBNP 40 + Ringer's acetate

Lower body negative pressure OTHER

Lower body negative pressure, 40 mmHg. Experimental hypovolemia.

LBNP 40 + Ringer's acetate; LBNP 40 + no intravenous fluid

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Medical Conditions
• 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. Prior/Concomitant Therapy
• Any drug (contraceptives excepted) used on a regular basis for a chronic condition (allergy excepted).

Sponsors & Collaborators

• Oslo University Hospital: lead
• University Hospital, Akershus: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0586, Norway

RECRUITING

MeSH Terms

Conditions

Hypovolemia

Interventions

Lower Body Negative Pressure

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Decompression; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-label using blinded randomization. The intervention to be taken by a participant will be assigned using randomization envelopes, opened at visit 1.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., PhD

Model Details: * Block randomized * Placebo controlled * Single center * Crossover * Factorial 2x2

Study Record Dates

• First Submitted: January 21, 2023
• First Posted: January 30, 2023
• Study Start: March 2, 2024
• Primary Completion: July 29, 2024
• Study Completion: July 29, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)