Ignite Creation Date:
2024-07-17 @ 11:06 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474052
Status:
COMPLETED
Last Update Posted:
2024-06-25
First Post:
2024-06-19
Brief Title:
Volume Kinetics of Gelofusine 4 During Vascular Surgery
Sponsor:
Institutul de Urgenţă pentru Boli Cardiovasculare ProfDr CC Iliescu
Organization:
Institutul de Urgenţă pentru Boli Cardiovasculare ProfDr CC Iliescu
Study Overview
Official Title:
Volume Kinetics of Gelofusine 4 During Uncomplicated Vascular Surgery
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The volume kinetics of the commercially available colloid fluid Gelofusine 4 have not been previously studied Adult patients undergoing open vascular surgery including femoral and carotid endarterectomy as well as bypass surgery received general anesthesia Following the induction of anesthesia Gelofusine 4 was administered at a dosage of 10 mlkg over a 30-minute period Hemoglobin concentration was monitored for up to 180 minutes post-administration to construct a plasma hemodilution profile
Detailed Description:
Gelofusine 4 was administered at a dosage of 10 mlkg over a 30-minute period to adult patients undergoing uncomplicated vascular surgery Arterial blood samples were taken to measure blood hemoglobin concentration and hematocrit at baseline and at 5-minute intervals up to 60 minutes after the infusion began followed by 10-minute intervals up to 90 minutes and then at 30-minute intervals up to 180 minutes Urine output and total intraoperative blood loss were continuously monitored The plasma hemodilution data were fitted to a bicompartmental model to derive the intercompartmental kinetics of Gelofusine 4
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None