Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06279793
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-09-13
Brief Title:
Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients
Sponsor:
GCP-Service International West GmbH
Organization:
GCP-Service International West GmbH
Study Overview
Official Title:
Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients a Phase II Multicenter Trial A Double-blind Randomized Placebo-controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
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:
MODIFY CSX
Brief Summary:
The MODIFY CSX study is a randomized double-blind controlled trial conducted in heart centers in Germany
In this prospective randomized controlled blinded multicenter trial a total of 120 high-risk cardiac surgery patients will receive either fish oil at 020 gkg body weight BW standard of care versus placebo standard of care
In this prospective randomized controlled blinded multicenter trial a total of 120 high-risk cardiac surgery patients will receive either fish oil at 020 gkg body weight BW standard of care versus placebo standard of care
Detailed Description:
The proposed hypothesis is that the therapeutic strategy tested in this randomized trial will decrease the occurrence of postoperative atrial fibrillation which ultimately lead to faster time to discharge alive This in turn significantly improves the patients mid and long-term outcomes and dramatically reduces associated healthcare related costs
Duration of intervention until discharge from ICU death or postoperative day 7 on ICU whichever comes first
Treatment Group Patients will receive fish oil in dose 020 gkg body weight BWd 2 mL Omegavenkg BWd
Control Group Patients will receive 09 NaCl in dose 2 mLkg BWd placebo
Follow-up per patient at day 30 month 3 6 and 12 months
Primary endpoint Phase II study
The primary endpoint for this phase II clinical trial is be the presence of new-onset atrial fibrillation after cardiac surgery AFACS until day 7 after surgery
Duration of intervention until discharge from ICU death or postoperative day 7 on ICU whichever comes first
Treatment Group Patients will receive fish oil in dose 020 gkg body weight BWd 2 mL Omegavenkg BWd
Control Group Patients will receive 09 NaCl in dose 2 mLkg BWd placebo
Follow-up per patient at day 30 month 3 6 and 12 months
Primary endpoint Phase II study
The primary endpoint for this phase II clinical trial is be the presence of new-onset atrial fibrillation after cardiac surgery AFACS until day 7 after surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None