Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-01-29 @ 9:51 AM
Study NCT ID:
NCT02782520
Status:
COMPLETED
Last Update Posted:
2018-04-30
First Post:
2016-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effects of an Hypertonic Solution With Ringer Lactate on Right Ventricular Function Following Cardiac Surgery
Sponsor:
University Hospital, Grenoble
Organization:
Study Overview
Official Title:
Comparison of the Effects of an Hypertonic Solution With Ringer Lactate on Right Ventricular Function Following Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2017-11
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:
SUCCESS
Brief Summary:
This study is a phase III, randomized, controled, parallel groups, single blinded, clinical trial that aims at comparing the improvement of right ventricular function after administration of a hypertonic solution versus Ringer Lactate following cardiac surgery.
Adults patients admitted to Grenoble University Hospital for elective cardiac surgery under cardiopulmonary bypass, in sinus rhythm and with Swan Ganz monitoring will be included.
Patients needing fluid expansion in the first three hours after surgery will be randomized in two groups : one receiving Ringer Lactate (10 mL/kg), the other receiving hypertonic saline solution (3 mL/kg).
Right ventricular function measured with Swan Ganz catheter, 30 minutes after fluid expansion will be the primary outcome.
Adults patients admitted to Grenoble University Hospital for elective cardiac surgery under cardiopulmonary bypass, in sinus rhythm and with Swan Ganz monitoring will be included.
Patients needing fluid expansion in the first three hours after surgery will be randomized in two groups : one receiving Ringer Lactate (10 mL/kg), the other receiving hypertonic saline solution (3 mL/kg).
Right ventricular function measured with Swan Ganz catheter, 30 minutes after fluid expansion will be the primary outcome.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: