Valvular SurgeryPhase 4IVFO-ValvularNCT00890838
Preoperative Intravenous Omega 3 Fatty Acids Administration in Valvular Surgery Patients
A Phase 4 study testing Omegaven-IV FO in people with Valvular Surgery and Inflammation, run by Nizam's Institute of Medical Sciences University, India at 1 site in India.
Trial summary
The perioperative administration of n-3 fatty acids has been shown to lead to favorable effects on outcome in patients with severe surgical interventions by lowering the magnitude of inflammatory response and by modulating the immune response. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Valvular Surgery, Inflammation
- What is being tested?
- Omegaven-IV FO
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2009to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult male or female patients undergoing valvular surgeries
- Age 18-50 years
- The patients who give written informed consent
Who cannot join
- Refusal to participate in the study
- Allergy to any of the constituents of nutritional products
- HIV positive patients, patients with primary diagnosis of hypertriglyceridemia, patients on long term steroid therapy and cycloxygenase inhibitors (more than 3 months)
- Severe cardiac disease, hepatic disorders (total bilirubin > 1.5 times the upper limit of normal), psychiatric disorders likely to affect compliance, severe hemorrhagic disorders, stroke, embolism
- Uncontrolled severe renal failure (Serum creatinine > 2 mg/dL) without dialysis/hemofiltration
- Pregnant or nursing women
- Participation in any other clinical trial within the last 2 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Intravenous Omega 3 Fatty Acids Administration in Valvular Surgery Patients: A Prospective, Randomized, Open-label, Comparative Clinical Trial
The perioperative administration of n-3 fatty acids has been shown to lead to favorable effects on outcome in patients with severe surgical interventions by lowering the magnitude of inflammatory response and by modulating the immune response. To the investigators' knowledge, no study with preoperative administration of intravenous (IV) omega 3 fatty acids as a part of total parenteral nutrition (TPN) or monotherapy with it to demonstrate its effects on inflammatory and immune response has been conducted. So, this study has been planned to judge the inflammatory response of preoperative monotherapy with IV omega 3 fatty acids in elderly patients undergoing valvular surgery considering the hyperinflammation associated with this type of surgery in elderly patients.
- Conditions
- Valvular Surgery, Inflammation
- Being tested
- Omegaven-IV FO
- Keywords
- IVFO, Inflammation, Valvular surgery, Inflammatory status, Infectious complications
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omegaven-IV FODietary supplement
will receive IV Omega 3 fatty acids (Omegaven®) for 3 pre operative days
| Study group | Role | What they receive |
|---|---|---|
| Omegaven | Active comparator | will receive IV Omega 3 fatty acids (Omegaven®) for 3 days preoperatively Receives: Dietary Supplement: Omegaven-IV FO |
| Without Omegaven | No intervention | will not receive IV Omega 3 fatty acids (Omegaven®) for 3 days preoperativel |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-6, 8, 10, HS-CRP
Measured: 5 days
Secondary outcomes (1)
Infectious complications
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nizam's Institute of Medical Sciences University, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. R. Gopinath, Nizam's Institute of Medical Sciences University, India
- Investigators
- Dr R Gopinath, Principal investigator, Professor and Head, Department of ANesthesia and critical care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890838
- Sponsor's protocol ID
- NIMS/2008/Omegaven/Surgery/02
- Acronym
- IVFO-Valvular
- Status last verified
- Oct 2014
- First submitted
- 28 Apr 2009
- Last updated
- 2 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Intravenous Omega 3 Fatty Acids Administration in Valvular Surgery Patients: A Prospective, Randomized, Open-label, Comparative Clinical Trial
- ClinicalTrials.gov ID
- NCT00890838
- Acronym / sponsor ID
- IVFO-Valvular / NIMS/2008/Omegaven/Surgery/02
- Conditions
- Valvular Surgery, Inflammation
- Keywords
- IVFO, Inflammation, Valvular surgery, Inflammatory status, Infectious complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nizam's Institute of Medical Sciences University, IndiaUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 30 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The perioperative administration of n-3 fatty acids has been shown to lead to favorable effects on outcome in patients with severe surgical interventions by lowering the magnitude of inflammatory response and by modulating the immune response. To the investigators' knowledge, no study with preoperative administration of intravenous (IV) omega 3 fatty acids as a part of total parenteral nutrition (TPN) or monotherapy with it to demonstrate its effects on inflammatory and immune response has been conducted. So, this study has been planned to judge the inflammatory response of preoperative monotherapy with IV omega 3 fatty acids in elderly patients undergoing valvular surgery considering the hyperinflammation associated with this type of surgery in elderly patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omegaven | Active comparator | Dietary Supplement: Omegaven-IV FOwill receive IV Omega 3 fatty acids (Omegaven®) for 3 days preoperatively |
| Without Omegaven | No intervention | –will not receive IV Omega 3 fatty acids (Omegaven®) for 3 days preoperativel |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult male or female patients undergoing valvular surgeries
- Age 18-50 years
- The patients who give written informed consent
Key exclusion criteria (7 listed)
- Refusal to participate in the study
- Allergy to any of the constituents of nutritional products
- HIV positive patients, patients with primary diagnosis of hypertriglyceridemia, patients on long term steroid therapy and cycloxygenase inhibitors (more than 3 months)
- Severe cardiac disease, hepatic disorders (total bilirubin > 1.5 times the upper limit of normal), psychiatric disorders likely to affect compliance, severe hemorrhagic disorders, stroke, embolism
- Uncontrolled severe renal failure (Serum creatinine > 2 mg/dL) without dialysis/hemofiltration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omegaven-IV FOwill receive IV Omega 3 fatty acids (Omegaven®) for 3 pre operative days | Dietary supplement | Omegaven |
Primary outcome
IL-6, 8, 10, HS-CRP
Time frame: 5 days
1 secondary outcome
Infectious complications
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr R Gopinath principal investigator
Professor and Head, Department of ANesthesia and critical care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omegaven-IV FO in people with Valvular Surgery and Inflammation, run by Nizam's Institute of Medical Sciences University, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-6, 8, 10, HS-CRP (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2014; AzTrials last refreshed its copy on 7 Nov 2026.