Acetated Ringer´s solution in experimental hypovolemia

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Oslo University Hospital HF

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14], Phenomena and Processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

Trial duration

2 Mar 2024 → 30 Oct 2025

Decision date (initial)

2023-06-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Oslo University Hospital · Akershus University Hospital

External identifiers

EU CT number

2023-503946-30-00

ClinicalTrials.gov

NCT05705115

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Pharmacodynamic

To assess the duration of hemodynamic effect of bolus Ringer`s acetate

Secondary objectives 2

1. To assess the duration of volume effect of bolus Ringer`s acetate
2. To assess the duration of cerebrovascular effect of bolus Ringer`s acetate

Conditions and MedDRA coding

Hypovolemia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Participant must be 18 to 40 years of age inclusive, at the time of signing the informed consent
2. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination and focused cardiac ultrasound
3. Female participants: Use of adequate birth control for women of childbearing potential
4. 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 6

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Half-life of cardiac stroke volume relative to baseline

Secondary endpoints 2

1. Half-life of intravascular volume relative to baseline
2. Half-life of MCAv integral relative to baseline

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Oslo University Hospital HF

Sponsor organisation

Oslo University Hospital HF

Address

Taarnbygget, Kirkeveien 166 Kirkeveien 166

City

Oslo

Postcode

0450

Country

Norway

Scientific contact point

Organisation

Oslo University Hospital HF

Contact name

Principal investigator

Public contact point

Organisation

Oslo University Hospital HF

Contact name

Principal investigator

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

4 submissions — initial application plus substantial / non-substantial modifications