Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622499
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-06-17
Brief Title:
The Colder Fluids - Intravenous Infusion of 10 Degrees Celsius Fluids and Its Effects on Circulation and Hemostasis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Rapid Intravenous Infusion of 10 and 22 Degrees Celsius Ringers Lactate in Healthy Volunteers and Its Effects on Circulation and Hemostasis - a Randomized Crossover Trial
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to investigate the effect of respectively 10 and 22 degrees Celsius Ringers 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 Ringers lactate either cold 10C 50F or at room temperature 22C 716F with 100 mlmin 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None