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Effect of warm and cold fluid therapy

Hemodynamic effects from administration of body temperature warmed versus room temperature fluid boluses in healthy volunteers

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2016-002548-18-SE
Enrollment
Unknown
Registered
2016-08-08
Start date
2016-10-04
Completion date
Unknown
Last updated
2017-07-24

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

Conditions

This trial will be a crossover study of healthy volunteers receiving a warm vs a cold fluid bolus to investigate the difference in hemodynamic response. While this will generate data for future studies in other categories (hypotension, sepsis etc), the volunteers will have no medical conditions.

Interventions

Trade Name: Ringer-acetate Product Name: Ringer acetate Product Code: ATC kod: B05BB01 Pharmaceutical Form: Solution for injection/infusion Pharmaceutical form of the placebo: Solution for infusion R

Sponsors

Karolinska Institutet Södersjukhuset
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Healthy volunteers Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 21 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: Medical disease corresponding to American Society of Anaesthesiology grade II or more

Design outcomes

Primary

MeasureTime frame
Main Objective: To determine the difference in cardiac output between the two groups;Secondary Objective: To determine the difference in blood pressure, microcirculation, temperature and duration of these effects;Primary end point(s): Cardiac output;Timepoint(s) of evaluation of this end point: 15 minutes

Secondary

MeasureTime frame
Secondary end point(s): Pulse, blood pressure and temperature changes as well as functional microvessel density. Duration of these;Timepoint(s) of evaluation of this end point: 30, 60 90 and 120 minutes

Countries

Sweden

Contacts

Public ContactKI SÖS

Karolinska Institutet Södersjukhuset

+468616 29 35

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026