The Cold Fluids Study

NCT05610254 | Completed Phase 4 DMC

• 1 other identifier: 2022-002137-34
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamic Instability

Outcome Measures

Primary Outcomes (1)

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

  15 minutes

Secondary Outcomes (1)

• Time until return of MAP to baseline value after infusion.

  2 hours

Study Arms (2)

Cold-Warm

ACTIVE COMPARATOR

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

Warm-Cold

ACTIVE COMPARATOR

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

Interventions

Ringer's Lactate DRUG

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.

Cold-Warm; Warm-Cold

Eligibility Criteria

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

You may qualify if:

• Age between 18-64

You may not qualify if:

• 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.

Sponsors & Collaborators

• Esbjerg Hospital - University Hospital of Southern Denmark: lead
• Odense University Hospital: collaborator
• University of Southern Denmark: collaborator
• Simon Fougner Hartmanns Family Foundation: collaborator
• Department of Clinical Biochemistry, Vejle Hospital: collaborator

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

• Biesenbach P, Molmer MB, Svendsen EL, Teichmann D, Wuthe S, Momeni M, Kristensen MR, Laugesen LE, Berg-Beckhoff G, Bentsen LP, Bergmann ML, Brabrand M. Ringer's lactate administered at 15 degrees C leads to a greater and more prolonged increase in blood pressure compared to 37 degrees C. Sci Rep. 2024 Oct 26;14(1):25592. doi: 10.1038/s41598-024-76858-0.

  PMID: 39462030 DERIVED

MeSH Terms

Interventions

Ringer's Lactate

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 9, 2022
• Study Start: October 24, 2022
• Primary Completion: December 3, 2022
• Study Completion: December 3, 2022
• Last Updated: September 5, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)