Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00431743
Status:
UNKNOWN
Last Update Posted:
2009-03-03
First Post:
2007-02-05
Brief Title:
Fluid Infusion During Breast Surgery
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Phase 4 Study of Fluid Infusion During Breast Surgery
Status:
UNKNOWN
Status Verified Date:
2009-02
Last Known Status:
NOT_YET_RECRUITING
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 investigators want to investigate the effects of two different kinds of fluid infusions given during varicose vein surgery Both types of fluid are regularly given during surgery and the investigators want to compare their respective effects on balance nauseavomiting and orthostatic function after surgery
The investigators hypothesis is that using a colloid solution will improve orthostatic function balance nauseavomiting and reduce hospital stay
The investigators hypothesis is that using a colloid solution will improve orthostatic function balance nauseavomiting and reduce hospital stay
Detailed Description:
The optimal amount and type of fluid given during surgery has not been defined It has been agreed that hypovolemia must be avoided but at the same time it has been agreed that fluid excess is harmful for organ functionWhen distributing fluids it is usually either crystalloids og colloids which are given The effects of the two types of fluid have not been compared Our hypothesis is that using a colloid HES 13004 will improve orthostatic function nauseavomiting and shorten hospital stay compared to using a crystalloid Lactated Ringers solutionThe amount of fluid the patient receives will be individually tailored by monitoring SV using esophageal Doppler technique during surgery
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