NCT06622499

Brief Summary

The aim of this study is to investigate the effect of respectively 10 and 22 degrees Celsius Ringer's lactate solution on the physiological response in healthy adults. In a single center crossover study the investigators will include and randomize 25 healthy volunteers to receive 1 liter of Ringer's lactate either cold (10°C, 50°F), or at room temperature (22°C, 71,6°F) with 100 ml/min. 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. The main outcomes of this study are: Primary:

  • The increase in Mean Arterial Pressure (MAP) 30 minutes after started infusion Secondary:
  • Time until return of MAP to baseline value after infusion.
  • Changes in Visual Analog Scale (VAS) of discomfort 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 the fluid responsiveness
  • Changes in biochemical parameters at baseline, 30 and 60 minutes.
  • Changes in Rotational thromboelastometry (ROTEM) analysis at baseline, 30 and 60 minutes

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2023

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 2, 2024

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

1 month

First QC Date

June 17, 2024

Last Update Submit

October 4, 2024

Conditions

Hemodynamic Instability

Outcome Measures

Primary Outcomes (1)

  • Increase in Mean Arterial Pressure (MAP) 30 minutes after started infusion

    Trial day 1 & Trial day 2

Secondary Outcomes (16)

  • Time until return of Mean Arterial Pressure (MAP) to baseline value after infusion

    Trial day 1 & Trial day 2

  • Changes in Visual Analog Scale (VAS) of discomfort during infusion

    Trial day 1 & Trial day 2

  • Changes in physiological parameter temperature measured in degrees Celcius

    Trial day 1 & Trial day 2

  • Changes in physiological parameter blood pressure measured in millimeter of mercury (mmHg)

    Trial day 1 & Trial day 2

  • Changes in physiological parameter peripheral oxygen saturation measured in percent (%)

    Trial day 1 & Trial day 2

  • +11 more secondary outcomes

Study Arms (2)

Cold - Room temperature

ACTIVE COMPARATOR

Trial day 1: Participants receive Ringer's lactate cold (10°C, 50°F), Trial day 2: Participants receive Ringer's lactate at room temperature (22°C, 71.6°F)

Drug: Ringer's Lactate

Room temperature - Cold

ACTIVE COMPARATOR

Trial day 1: Participants receive Ringer's lactate at room temperature (22°C, 71.6°F), Trial day 2: Participants receive Ringer's lactate cold (10°C, 50°F)

Drug: Ringer's Lactate

Interventions

Ringer's LactateDRUG

On the first trial day healthy volunteers are randomized to receive 1 liter of Ringer's lactate either cold (10°C, 50°F), or at room temperature (22°C, 71.6°F) with 100 ml/min. After a minimum "washout period" of 24 hours, subjects are switched to receive infusion at the other aforementioned temperatures.

Cold - Room temperatureRoom temperature - Cold

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18-64

You may not qualify if:

  • Pre-existing medical problems that are contraindicated for cold crystalloid infusions.
  • Pregnancy (validated through a certified urine pregnancy test)
  • Body mass index \>35 kg/m2
  • Medication use, including over-the-counter anti-pyretics within 48 hours, with exception of allergy medication and contraceptives.
  • Any family history or predisposition of coagulopathies.
  • Any intake of inhibitors of 11β-Hydroxysteroid dehydrogenase the past 48 hours (products containing liquorice)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Interventions

Ringer's Lactate

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Mikkel Brabrand, MD

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2024

First Posted

October 2, 2024

Study Start

November 6, 2023

Primary Completion

December 20, 2023

Study Completion

December 20, 2023

Last Updated

October 8, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)