Overview
Sponsor-declared trial summary
Hemodynamic parameters is to be investigated -- comparing cold fluids 10 degrees celsius to room temperature 22 degrees celsius
This randomized controlled crossover study investigates the effect of Ringer's lactate solution at high and low temperatures on physiological response in healthy adults.
Key facts
- Sponsor
- Sydvestjysk Sygehus
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
- Trial duration
- 6 Nov 2023 → 20 Dec 2023
- Decision date (initial)
- 2023-09-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Therapy, Efficacy
This randomized controlled crossover study investigates the effect of Ringer's lactate solution at high and low temperatures on physiological response in healthy adults.
Conditions and MedDRA coding
Hemodynamic parameters is to be investigated -- comparing cold fluids 10 degrees celsius to room temperature 22 degrees celsius
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Age between 18-64
Exclusion criteria 6
- 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)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary outcome of the study is the increase in mean arterial pressure (MAP) 30 minutes after started infusion of the fluid bolus measured via standard non-invasive blood pressure cuff.
Secondary endpoints 6
- Time until return of MAP to baseline value after infusion.
- Changes in VAS 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 fluid responsiveness
- Changes in biochemical parameters at baseline, 30 and 60 minutes
- Changes in ROTEM analysis at baseline, 30 and 60 minutes
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD2085402 · Product
- Active substance
- Potassium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1 l litre(s)
- Max total dose
- 2 l litre(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BB01 — ELECTROLYTES
- Marketing authorisation
- 06756
- MA holder
- FRESENIUS KABI AB
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sydvestjysk Sygehus
- Sponsor organisation
- Sydvestjysk Sygehus
- Address
- Finsensgade 35
- City
- Esbjerg
- Postcode
- 6700
- Country
- Denmark
Scientific contact point
- Organisation
- Sydvestjysk Sygehus
- Contact name
- Peter Biesenbach
Public contact point
- Organisation
- Sydvestjysk Sygehus
- Contact name
- Peter Biesenbach
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 25 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2023-11-06 | 2023-12-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Ringer´s lactate given at 10°C results in a greater blood pressure increase compared to 22°C | 2024-12-20T21:06:19 | Submitted | Laypersons Summary of Results |
Documents 1 file
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Layman summary COLDER fluids | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-28 | Denmark | Acceptable 2023-09-08
|
2023-09-08 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-01-25 | Denmark | Acceptable 2023-09-08
|
2024-01-25 |