The Cold Fluids Study

Sponsor

Hospital of South West Jutland (Other)

Overall Status

Completed

CT.gov ID

NCT05610254

Collaborator

Odense University Hospital (Other), University of Southern Denmark (Other), Simon Fougner Hartmanns Family Foundation (Other), Department of Clinical Biochemistry, Vejle Hospital (Other)

Enrollment

Location

Arms

1.3

Actual Duration (Months)

13.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this single center crossover study the aim is to investigate the effect of Ringer's lactate solution at high and low temperatures on physiological response in healthy adults.18 healthy volunteers will be included. Inclusion criteria is; Age between 18-64. Exclusion criteria is; Pre-existing medical problems, Pregnancy (validated through a certified pregnancy test), Body mass index >35 kg/m2, Medication use apart from allergy medication, contraceptives, or non-steroidal anti-inflammatory drugs.

Participants will be randomized to receive 30 ml/kg of Ringer's lactate either cold (15°C, 59°F), or at body temperature (37°C, 98.6°F) during a 30-minute interval. Fluids will be administered through a peripheral vein. After a minimum "washout period" of 24 hours, subjects are switched to receive infusion at the other aforementioned temperatures.

Primary outcome is

The increase in MAP at 15 minutes after infusion of the fluid bolus. Secondary outcome is
Time until return of MAP to baseline value after infusion.

Condition or Disease	Intervention/Treatment	Phase
Hemodynamic Instability	Drug: Ringer's Lactate	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Rapid Infusion of Ringer's Lactate Solution at Different Temperatures and the Effects on Circulation and Perfusion in Healthy Volunteers - a Randomized Crossover Trial

Actual Study Start Date :

Oct 24, 2022

Actual Primary Completion Date :

Dec 3, 2022

Actual Study Completion Date :

Dec 3, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cold-Warm Trial day 1: Participants receive Ringer's lactate cold (15°C, 59°F), Trial day 2: Participants receive Ringer's lactate at body temperature (37°C, 98.6°F)	Drug: Ringer's Lactate On the first trial day healthy volunteers are randomized to receive 30 ml/kg of Ringer's lactate either cold (15°C, 59°F), or at body temperature (37°C, 98.6°F) during a 30-minute interval. After a minimum "washout period" of 24 hours, subjects are switched to receive infusion at the other aforementioned temperatures.
Active Comparator: Warm-Cold Trial day 1: Participants receive Ringer's lactate at body temperature (37°C, 98.6°F) Trial day 2: Participants receive Ringer's lactate cold (15°C, 59°F),	Drug: Ringer's Lactate On the first trial day healthy volunteers are randomized to receive 30 ml/kg of Ringer's lactate either cold (15°C, 59°F), or at body temperature (37°C, 98.6°F) during a 30-minute interval. After a minimum "washout period" of 24 hours, subjects are switched to receive infusion at the other aforementioned temperatures.

Arm

Intervention/Treatment

Active Comparator: Cold-Warm

Trial day 1: Participants receive Ringer's lactate cold (15°C, 59°F), Trial day 2: Participants receive Ringer's lactate at body temperature (37°C, 98.6°F)

Drug: Ringer's Lactate

On the first trial day healthy volunteers are randomized to receive 30 ml/kg of Ringer's lactate either cold (15°C, 59°F), or at body temperature (37°C, 98.6°F) during a 30-minute interval. After a minimum "washout period" of 24 hours, subjects are switched to receive infusion at the other aforementioned temperatures.

Active Comparator: Warm-Cold

Trial day 1: Participants receive Ringer's lactate at body temperature (37°C, 98.6°F) Trial day 2: Participants receive Ringer's lactate cold (15°C, 59°F),

Drug: Ringer's Lactate

Outcome Measures

Primary Outcome Measures

Increase in MAP at 15 minutes after infusion of the fluid bolus. [15 minutes]

Secondary Outcome Measures

Time until return of MAP to baseline value after infusion. [2 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age between 18-64

Exclusion Criteria:

Pre-existing medical problems
Pregnancy (validated through a certified pregnancy test)
Body mass index >35 kg/m2
Medication use apart from allergy medication, contraceptives, or non-steroidal anti-inflammatory drugs.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Odense University Hospital	Odense		Denmark	5000

Sponsors and Collaborators

Hospital of South West Jutland
Odense University Hospital
University of Southern Denmark
Simon Fougner Hartmanns Family Foundation
Department of Clinical Biochemistry, Vejle Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospital of South West Jutland

ClinicalTrials.gov Identifier:

NCT05610254

Other Study ID Numbers:

2022-002137-34

First Posted:

Nov 9, 2022

Last Update Posted:

Jan 30, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 30, 2023