VasoplegiaPhase 3CORTIVAS-CSNCT04301479
Low Dose Corticosteroid Infusion in Vasoplegia After Cardiac Surgery (CORTIVAS-CS)
A Phase 3 study testing hydrocortisone sodium succinate and Saline in people with Vasoplegia and Cardiac Surgery, run by Instituto do Coracao at 1 site in Brazil.
Trial summary
Vasoplegia is an important determinant for adverse postoperative outcome and is observerd in 5% to 54% of patients undergoing cardiac surgery using cardiopulmonary bypass (CPB). Postoperative vasoplegia is defined as a state with low systemic vascular resistance despite a normal or high cardiac output, and the need… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vasoplegia, Cardiac Surgery
- What is being tested?
- hydrocortisone sodium succinate and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2020to Mar 2021
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cardiac surgery with cardiopulmonary bypass
- Norephinerine treatment in ICU with dose great or equal than 0,1 mcg/kg/min to maintain or restore a MAP over 70 mmHg for at least 30 minutes within 24 hours after surgery
Who cannot join
- Preoperative vasopressor use (within 72 hours prior to surgery)
- Preoperative steroids use (within 7 days prior to surgery)
- Presence of ventricular assist device other than intraaortic ballon pump
- Transplant procedures
- Emergency procedures
- Aortic repairs
Show all 14Show fewer
- Congenital procedures
- Endocarditis
- Bacterial or fungal infection in the preceding 30 days
- Active neoplasia
- Pregnancy
- Recent history of gastrointestinal bleeding
- Allergy or intolerance to steroids
- Participation in other study
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Incor - Heart Institute - University of Sao Paulo
São Paulo, 05403000
About this study
Official title: Low Dose Corticosteroid Infusion in Vasoplegia After Cardiac Surgery (CORTIVAS-CS): a Prospective Randomized Double-blinded Clinical Trial
Vasoplegia is an important determinant for adverse postoperative outcome and is observerd in 5% to 54% of patients undergoing cardiac surgery using cardiopulmonary bypass (CPB).
Postoperative vasoplegia is defined as a state with low systemic vascular resistance despite a normal or high cardiac output, and the need for vasopressor therapy.
Steroids attenuate the inflammatory response to cardiopulmonary bypass,but their effect on clinical outcomes is uncertain.
This is a double-blinded, randomized, clinical trial designed to determine the efficacy of low dose corticosteroid infusion in vasopressor free-days in vasoplegia after cardiac surgery.
- Conditions
- Vasoplegia, Cardiac Surgery
- Being tested
- hydrocortisone sodium succinate, Saline
- Keywords
- vasoplegia, cardiac surgery, steroids
- Medical subject headings
- Vasoplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrocortisone sodium succinateDrug
Steroid group will receive 200 mg of hydrocortisone diluted in 120 mL of saline at an infusion rate of 5mL/hr for 3 days or shock reversal
SalineDrug
Control group will receive 120 mL of saline solution at a rate of 5mL/hr for 3 days or shock reversal
| Study group | Role | What they receive |
|---|---|---|
| Steroid | Active comparator | Patients assigned for steroid group will receive 200 mg of hydrocortisone diluted in 120 mL of saline at an infusion rate of 5mL/hr for 3 days or shock reversal, defined by systolic arterial pressure > 90 mmHg for 12 hours after vasopressor weaning without fluid expansion. Receives: Drug: hydrocortisone sodium succinate |
| Control | Placebo comparator | Patients assigned for control group will receive 120 mL of saline solution at a rate of 5mL/hr for 3 days or shock reversal, defined by systolic arterial pressure > 90 mmHg for 12 hours after vasopressor weaning without fluid expansion. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasopressors-free days
Days free of vasopressors up to day 30
Measured: 30 days
Secondary outcomes (5)
30 days mortallity
The number of deaths within 30 days of surgery
Measured: 30 days
ICU length of stay
Duration in days from the date of the ICU admission to the date of ICU discharge
Measured: 30 days
Infection complication
Rate of new infection or septic shock within 30 days after randomization
Measured: 30 days
Acute myocardial infarction
We will compare the incidence of acute myocardial infarction between groups within 30 days after randomization
Measured: 30 days
Atrial fibrillation
We will compare the incidence of atrial fibrillation between groups within 30 days after randomization
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study startMar 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VasoplegiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto do Coracao
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Filomena R B G Galas, Instituto do Coracao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301479
- Sponsor's protocol ID
- InCor - HCFMUSP
- Acronym
- CORTIVAS-CS
- Status last verified
- Mar 2020
- First submitted
- 27 Feb 2020
- Last updated
- 10 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Corticosteroid Infusion in Vasoplegia After Cardiac Surgery (CORTIVAS-CS): a Prospective Randomized Double-blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT04301479
- Acronym / sponsor ID
- CORTIVAS-CS / InCor - HCFMUSP
- Conditions
- Vasoplegia, Cardiac Surgery
- Keywords
- vasoplegia, cardiac surgery, steroids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Instituto do CoracaoOther government
- Study start
- Mar 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 10 Mar 2020 (actual)
- 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.
Vasoplegia is an important determinant for adverse postoperative outcome and is observerd in 5% to 54% of patients undergoing cardiac surgery using cardiopulmonary bypass (CPB).
Postoperative vasoplegia is defined as a state with low systemic vascular resistance despite a normal or high cardiac output, and the need for vasopressor therapy.
Steroids attenuate the inflammatory response to cardiopulmonary bypass,but their effect on clinical outcomes is uncertain.
This is a double-blinded, randomized, clinical trial designed to determine the efficacy of low dose corticosteroid infusion in vasopressor free-days in vasoplegia after cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steroid | Active comparator | Drug: hydrocortisone sodium succinatePatients assigned for steroid group will receive 200 mg of hydrocortisone diluted in 120 mL of saline at an infusion rate of 5mL/hr for 3 days or shock reversal, defined by systolic arterial pressure > 90 mmHg for 12 hours after vasopressor weaning without fluid expansion. |
| Control | Placebo comparator | Drug: SalinePatients assigned for control group will receive 120 mL of saline solution at a rate of 5mL/hr for 3 days or shock reversal, defined by systolic arterial pressure > 90 mmHg for 12 hours after vasopressor weaning without fluid expansion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cardiac surgery with cardiopulmonary bypass
- Norephinerine treatment in ICU with dose great or equal than 0,1 mcg/kg/min to maintain or restore a MAP over 70 mmHg for at least 30 minutes within 24 hours after surgery
Key exclusion criteria (14 listed)
- Preoperative vasopressor use (within 72 hours prior to surgery)
- Preoperative steroids use (within 7 days prior to surgery)
- Presence of ventricular assist device other than intraaortic ballon pump
- Transplant procedures
- Emergency procedures
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 |
|---|---|---|
| hydrocortisone sodium succinateSteroid group will receive 200 mg of hydrocortisone diluted in 120 mL of saline at an infusion rate of 5mL/hr for 3 days or shock reversal | Drug | Steroid |
| SalineControl group will receive 120 mL of saline solution at a rate of 5mL/hr for 3 days or shock reversal | Drug | Control |
Primary outcome
Vasopressors-free days
Time frame: 30 days
Days free of vasopressors up to day 30
5 secondary outcomes
30 days mortallity
Time frame: 30 days
ICU length of stay
Time frame: 30 days
Infection complication
Time frame: 30 days
Acute myocardial infarction
Time frame: 30 days
Atrial fibrillation
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing hydrocortisone sodium succinate and Saline in people with Vasoplegia and Cardiac Surgery, run by Instituto do Coracao at 1 site in Brazil.
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 2 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 10 Mar 2020. 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 Brazil. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Vasopressors-free days (time frame: 30 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 10 Mar 2020.