Clinical Trial Results:
Rapid infusion of Ringer's lactate solution at different temperatures and the effects on circulation and perfusion in healthy volunteers – a randomized crossover trial
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Summary
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EudraCT number |
2022-002137-34 |
Trial protocol |
DK |
Global end of trial date |
02 Dec 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
17 Oct 2024
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First version publication date |
17 Oct 2024
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
SVS.FAM.01
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05610254 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Emergency Department
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Sponsor organisation address |
Finsensgade 35, Esbjerg, Denmark, 6700
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Public contact |
Peter Biesenbach, Hospital of South West Jutland, peter.biesenbach@rsyd.dk
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Scientific contact |
Peter Biesenbach, Hospital of South West Jutland, +45 53861985, peter.biesenbach@rsyd.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Apr 2024
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
02 Dec 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
02 Dec 2022
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
This randomized controlled crossover study investigates the effect of Ringer's lactate solution at high and low temperatures on physiological response in healthy adults.
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Protection of trial subjects |
During the active part of the trial, discomfort was measured every 5 minutes via a Numeric pain rating scale (NPRS) labelled from zero (no discomfort) to 10 (maximal discomfort imaginable)
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Background therapy |
None | ||
Evidence for comparator |
Not applicable | ||
Actual start date of recruitment |
05 Sep 2022
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 18
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Worldwide total number of subjects |
18
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EEA total number of subjects |
18
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
18
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Eighteen healthy volunteers were recruited among medical students from the local campus from September to December 2022. | |||||||||
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Pre-assignment
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Screening details |
The inclusion criteria were defined as adults aged 18 years or older. Exclusion criteria included pregnancy, body mass index >35 kg/m2, pre-existing medical problems or regular use of any medication apart from allergy medication, contraceptives or non-steroidal anti-inflammatory drugs. | |||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
No
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Arm title
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Intervention - COLD | |||||||||
Arm description |
Participants received 30 ml/kg of Ringer's lactate (Fresenius Kabi, Denmark). The fluid bolus was infused at cold (15°C, 59°F) temperature over a 30-minute period | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Ringers´ lactate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Infusion
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Dosage and administration details |
A 18G peripheral venous catheter was inserted in a vein located in the antecubital fossa and used for the administration of fluids. Participants received 30 ml/kg of Ringer's lactate (Fresenius Kabi, Denmark). The fluid bolus was infused at cold (15°C, 59°F) over a 30-minute period as per the randomization. The infusion bags were insulated within a neoprene wine cooler, and pressure bags were used to ensure a continuous and timely infusion.
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Arm title
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Intervention - Warm | |||||||||
Arm description |
Participants received 30 ml/kg of Ringer's lactate (Fresenius Kabi, Denmark). The fluid bolus was infused at body temperature (37°C, 98.6°F) over a 30-minute period. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Ringers´ lactate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Infusion
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Dosage and administration details |
A 18G peripheral venous catheter was inserted in a vein located in the antecubital fossa and used for the administration of fluids. Participants received 30 ml/kg of Ringer's lactate (Fresenius Kabi, Denmark). The fluid bolus was infused at body temperature (37°C, 98.6°F) over a 30-minute period as per the randomization. The infusion bags were insulated within a neoprene wine cooler, and pressure bags were used to ensure a continuous and timely infusion.
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
The total number of participants is 18, which where analysed twice due to the cross-over design. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Intervention - COLD
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Reporting group description |
Participants received 30 ml/kg of Ringer's lactate (Fresenius Kabi, Denmark). The fluid bolus was infused at cold (15°C, 59°F) temperature over a 30-minute period | ||
Reporting group title |
Intervention - Warm
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Reporting group description |
Participants received 30 ml/kg of Ringer's lactate (Fresenius Kabi, Denmark). The fluid bolus was infused at body temperature (37°C, 98.6°F) over a 30-minute period. | ||
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End point title |
Change in mean arterial pressure after 45 minutes | ||||||||||||
End point description |
Blood pressure was measured via a bedside monitor (Intellivue, Phillips, Denmark).
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End point type |
Primary
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End point timeframe |
Measured at 45 minutes after start of intravenous infusion.
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Statistical analysis title |
Primary outcome analysis | ||||||||||||
Comparison groups |
Intervention - COLD v Intervention - Warm
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Number of subjects included in analysis |
36
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.001 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
September until December 2022.
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Adverse event reporting additional description |
Adverse events were monitored and reported for the total observation period of 2 hours on the day of intervenion.
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Assessment type |
Non-systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
No dictionary | ||
Dictionary version |
0
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| Frequency threshold for reporting non-serious adverse events: 5% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No adverse event of any type were reported. This is perhaps due to three reasons. 1. the short observation period of 2 hours during and after infusion. 2. intravenous isotonic fluids, such as Ringer´s lactate, are the most common type of medicine used globally and extremely safe. 3. the trial participants were all healthy young medical students with no part medical history. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
