ShockPhase 3VaNCSNCT01505231
Vasopressin Versus Norepinephrine for the Management of Shock After Cardiac Surgery
A Phase 3 study testing Vasopressin and Norepinephrine in people with Shock, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Vasoplegic syndrome after cardiac surgery is a common complication after cardiac surgery, with negative impact on patient outcomes and hospital costs. Pathogenesis of vasodilatory phenomenon after cardiac surgery remains a matter of controversy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock
- What is being tested?
- Vasopressin and Norepinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2012to May 2013
- 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
- need vasopressor support
Who cannot join
- younger than 18 years;
- surgery without cardiopulmonary bypass;
- emergency procedure;
- ascending and descending thoracic aortic procedures;
- left ventricular aneurysm resection; enrollment in another study;
- pregnancy;
Show all 12Show fewer
- neoplasm;
- Raynaud's phenomenon, systemic sclerosis or vasospastic diathesis;
- severe hyponatremia (Na<130mEq/L);
- acute mesenteric ischemia;
- acute myocardial infarction;
- cardiogenic shock; and refusal to consent
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Coração
São Paulo, São Paulo, 05403-000
Ludhmila Hajjar, MD, PhD, 55-11-93194401, ludhmila@usp.br
About this study
Vasoplegic syndrome after cardiac surgery is a common complication after cardiac surgery, with negative impact on patient outcomes and hospital costs. Pathogenesis of vasodilatory phenomenon after cardiac surgery remains a matter of controversy. Loss of vascular tone can be partly explained by the depletion of neurohypophyseal arginine vasopressin stores. The investigators hypothesized that the use of arginine vasopressin would be more effective on treatment of shock after cardiac surgery than norepinephrine, decreasing the composite end point of mortality and severe morbidity.
- Conditions
- Shock
- Being tested
- Vasopressin, Norepinephrine
- Keywords
- Shock, norepinephrine, vasopressin, cardiac surgery
- Medical subject headings
- Shock, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VasopressinDrug
Blinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement.
NorepinephrineDrug
Blinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement
| Study group | Role | What they receive |
|---|---|---|
| Norepinephrine group | Active comparator | Blinded norepinephrine Receives: Drug: Norepinephrine |
| Vasopressin Group | Active comparator | Blinded vasopressin Receives: Drug: Vasopressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of major morbidity according to Society of Thoracic Surgery
The primary end point is major morbidity according to STS (30-days mortality, mechanical ventilation > 48 hours, mediastinitis, surgical reexploration, stroke, acute renal failure)
Measured: 30 days
Secondary outcomes (5)
Hemodynamic effects
the time to attainment of hemodynamic stability ; the changes in hemodynamic variables; and the use of dobutamine or other inotropic agents.
Measured: 28 days
occurence of adverse events and safety
Adverse events were categorized as arrhythmias, myocardial necrosis, skin necrosis, ischemia in limbs or distal extremities, or secondary infections
Measured: 28 days
Time on mechanical ventilation
Days on mechanical ventilation during 30-days after surgery.
Measured: 30 days
Incidence of infecction
Incidence of new infecction, sepsis, severe sepsis or septic shock in 30 days after surgery.
Measured: 30-days
Length of ICU and Hospital stay
Compare between groups the period of time (days) that patients were in ICU and in Hospital.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionFeb 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ShockStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ludhmila Abrahão Hajjar, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01505231
- Sponsor's protocol ID
- 0352/08
- Acronym
- VaNCS
- Status last verified
- Feb 2013
- First submitted
- 2 Jan 2012
- Last updated
- 12 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
O'Callaghan DJ, Gordon AC. What's new in vasopressin? Intensive Care Med. 2015 Dec;41(12):2177-9. doi: 10.1007/s00134-015-3849-3. Epub 2015 May 7. No abstract available.
PubMed 25947955
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasopressin Versus Norepinephrine for the Management of Shock After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01505231
- Acronym / sponsor ID
- VaNCS / 0352/08
- Conditions
- Shock
- Keywords
- Shock, norepinephrine, vasopressin, cardiac surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Feb 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 6 Jan 2012 (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.
Vasoplegic syndrome after cardiac surgery is a common complication after cardiac surgery, with negative impact on patient outcomes and hospital costs. Pathogenesis of vasodilatory phenomenon after cardiac surgery remains a matter of controversy. Loss of vascular tone can be partly explained by the depletion of neurohypophyseal arginine vasopressin stores. The investigators hypothesized that the use of arginine vasopressin would be more effective on treatment of shock after cardiac surgery than norepinephrine, decreasing the composite end point of mortality and severe morbidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Norepinephrine group | Active comparator | Drug: NorepinephrineBlinded norepinephrine |
| Vasopressin Group | Active comparator | Drug: VasopressinBlinded vasopressin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- need vasopressor support
Key exclusion criteria (12 listed)
- younger than 18 years;
- surgery without cardiopulmonary bypass;
- emergency procedure;
- ascending and descending thoracic aortic procedures;
- left ventricular aneurysm resection; enrollment in another study;
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 |
|---|---|---|
| VasopressinBlinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement. | Drug | Vasopressin Group |
| NorepinephrineBlinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement | Drug | Norepinephrine group |
Primary outcome
Composite endpoint of major morbidity according to Society of Thoracic Surgery
Time frame: 30 days
The primary end point is major morbidity according to STS (30-days mortality, mechanical ventilation > 48 hours, mediastinitis, surgical reexploration, stroke, acute renal failure)
5 secondary outcomes
Hemodynamic effects
Time frame: 28 days
occurence of adverse events and safety
Time frame: 28 days
Time on mechanical ventilation
Time frame: 30 days
Incidence of infecction
Time frame: 30-days
Length of ICU and Hospital stay
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2013.
- Derived from this study: PubMed 25947955O'Callaghan DJ, Gordon AC. What's new in vasopressin? Intensive Care Med. 2015 Dec;41(12):2177-9. doi: 10.1007/s00134-015-3849-3. Epub 2015 May 7. No abstract available.
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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.
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 Vasopressin and Norepinephrine in people with Shock, run by University of Sao Paulo 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 1 inclusion and 12 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 12 Feb 2013. 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. 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?
Contact Ludhmila Hajjar, MD, PhD (55-11-93194401, ludhmila@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint of major morbidity according to Society of Thoracic Surgery (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01505231, which also lists 1 linked publication.
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 12 Feb 2013.