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Rapid intravenous infusion of 10 and 22 degrees Celcius Ringer's lactate in healthy volunteers and its effects on circulation and hemostasis - a randomized crossover trial

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506018-35-00
Acronym
SVS.FAM.02
Enrollment
25
Registered
2023-09-08
Start date
2023-11-06
Completion date
2023-12-20
Last updated
2024-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic parameters is to be investigated -- comparing cold fluids 10 degrees celsius to room temperature 22 degrees celsius

Brief summary

The primary outcome of the study is the increase in mean arterial pressure (MAP) 30 minutes after started infusion of the fluid bolus measured via standard non-invasive blood pressure cuff.

Detailed description

Time until return of MAP to baseline value after infusion., Changes in VAS during infusion, Changes in temperature, blood pressure, heart rate, peripheral oxygen saturation cardiac index, cardiac output, total peripheral resistance index, and stroke volume, Changes in the intravascular volume status and fluid responsiveness, Changes in biochemical parameters at baseline, 30 and 60 minutes, Changes in ROTEM analysis at baseline, 30 and 60 minutes

Interventions

DRUGRinger-lactat Fresenius Kabi

Sponsors

Sydvestjysk Sygehus
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
The primary outcome of the study is the increase in mean arterial pressure (MAP) 30 minutes after started infusion of the fluid bolus measured via standard non-invasive blood pressure cuff.

Secondary

MeasureTime frame
Time until return of MAP to baseline value after infusion., Changes in VAS during infusion, Changes in temperature, blood pressure, heart rate, peripheral oxygen saturation cardiac index, cardiac output, total peripheral resistance index, and stroke volume, Changes in the intravascular volume status and fluid responsiveness, Changes in biochemical parameters at baseline, 30 and 60 minutes, Changes in ROTEM analysis at baseline, 30 and 60 minutes

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026