A Phase 1 interventional study of Ringer's Lactate in Hemodynamic Instability, sponsored by Esbjerg Hospital - University Hospital of Southern Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Esbjerg Hospital - University Hospital of Southern Denmark · Phase 1, Interventional, and Treatment
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:
Secondary:
Esbjerg Hospital - University Hospital of Southern Denmark is the lead sponsor of 45 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
Increase in Mean Arterial Pressure (MAP) 30 minutes after started infusion
Time frame: Trial day 1 & Trial day 2
Time until return of Mean Arterial Pressure (MAP) to baseline value after infusion
Time frame: Trial day 1 & Trial day 2
Changes in Visual Analog Scale (VAS) of discomfort during infusion
Visual analoge scale of discomfort to assess participants discomfort during the trial. A scale labelled from 0=no discomfort to 10=maximum discomfort imaginable.
Time frame: Trial day 1 & Trial day 2
Changes in physiological parameter temperature measured in degrees Celcius
Time frame: Trial day 1 & Trial day 2
Changes in physiological parameter blood pressure measured in millimeter of mercury (mmHg)
Time frame: Trial day 1 & Trial day 2
Changes in physiological parameter peripheral oxygen saturation measured in percent (%)
Time frame: Trial day 1 & Trial day 2
Changes in physiological parameter cardiac index measured in L/min/m2
Time frame: Trial day 1 & Trial day 2
Changes in physiological parameter cardias output measured in L/min
Time frame: Trial day 1 & Trial day 2
Changes in physiological parameter total peripheral resistance index measured in dyn·s/cm5
Time frame: Trial day 1 & Trial day 2
Changes in physiological parameter stroke volume measured in mL
Time frame: Trial day 1 & Trial day 2
Changes in physiological parameter intravascular volume status and fluid responsiveness measured in vena cava inferior maximum diameter and index via ultrasound
Time frame: Trial day 1 & Trial day 2
Changes in physiological parameter of INR blood test measured in prothrombin time at baseline, after 30 minutes and after 60 minutes
Time frame: Trial day 1 & Trial day 2
Changes in physiological parameter APTT blood test measured in seconds at baseline, after 30 minutes and after 60 minutes
Time frame: Trial day 1 & Trial day 2
Changes in physiological parameter Fibrinogen blood test measured in µmol/L at baseline, after 30 minutes and after 60 minutes
Time frame: Trial day 1 & Trial day 2
Changes in physiological parameter Platelet count blood test measured in 109/L at baseline, after 30 minutes and after 60 minutes
Time frame: Trial day 1 & Trial day 2
Changes in physiological parameter Flowcytometry blood tests (CD63, CD62p, PAC-1) measured in % at baseline, after 30 minutes and after 60 minutes
Time frame: Trial day 1 & Trial day 2
Changes in physiological parameter Rotational thromboelastometry (EXTEM, INTEM, FIBTEM analysis of Clotting time and maximum clot formation) measured in seconds and millimeters, respectively, at baseline, after 30 minutes and after 60 minutes
Time frame: Trial day 1 & Trial day 2
Plan to share: No
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Esbjerg Hospital - University Hospital of Southern Denmark