Septic ShockPhase 3VANCS IINCT01718613
Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients
A Phase 3 study testing Vasopressin and Norepinephrine in people with Septic Shock, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
Although arginine vasopressin has been used as an additional drug in refractory shock in worldwide clinical practice, there are no prospective studies using it as a first choice therapy in patients with cancer and septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Vasopressin and Norepinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2012to May 2018
- 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
- Solid neoplasm needing ICU
- Septic Shock according standard criteria
Who cannot join
- Younger than 18 years;
- Pregnancy;
- Raynaud's phenomenon, systemic sclerosis or vasospastic diathesis;
- Severe hyponatremia (Na<130mEq/L);
- Acute mesenteric ischemia;
- Acute myocardial infarction;
Show all 11Show fewer
- Cardiogenic shock;
- Current use of vasopressor before randomization
- Expected ICU stay less than 24 hours
- Enrolled in another study;
- Refusal to consent.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Cancer do Estado de Sao Paulo
São Paulo, Sao Paulo/SP, 01246000
About this study
Although arginine vasopressin has been used as an additional drug in refractory shock in worldwide clinical practice, there are no prospective studies using it as a first choice therapy in patients with cancer and septic shock.
The aim of this study is assess if the use of arginine vasopressin would be more effective on treatment of septic shock in cancer patients than norepinephrine, decreasing the composite end point of mortality and organ failure in 28 days.
- Conditions
- Septic Shock
- Being tested
- Vasopressin, Norepinephrine
- Medical subject headings
- Shock, Septic
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 | Active comparator | Not described Receives: Drug: Norepinephrine |
| Vasopressin | Active comparator | Not described Receives: Drug: Vasopressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
Mortality from all causes in 28-day follow-up
Measured: 28-day from randomization
Secondary outcomes (6)
90-days mortality
Mortality from all causes 90 days after randomization
Measured: 90 days after randomization
Days alive and free of mechanical ventilation
Days alive and free of mechanical ventilation at 28-day follow-up
Measured: 28 days after randomization
Days alive and free of vasopressors
Days alive and free of any type of vasopressor agent at 28-day follow-up
Measured: 28 days after randomization
Days alive and free of renal replacement therapy
requirement of dialysis of hemofiltration at 28-day follow-up
Measured: 28 days after randomization
SOFA score in 24 hours
Severity of organ failure according to the Sequential Organ Failure Assessment (SOFA) score during the first 24 hours after randomization.
Measured: 24 hours after ICU admission
SOFA score in 96 hours
Severity of organ failure according to the Sequential Organ Failure Assessment (SOFA) score during the first 96 hours after randomization.
Measured: 96 hours after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionMar 2014
- Study completionMay 2018
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 Septic ShockStudies 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristiane Maciel Zambolim, Instituto do Cancer do Estado de São Paulo
- Investigators
- Cristiane M Zambolim, MD, Principal investigator, Department of Anesthesia and Critical Care, Intensive Care Unit - ICESP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718613
- Sponsor's protocol ID
- NP 1079/17
- Acronym
- VANCS II
- Status last verified
- May 2018
- First submitted
- 29 Oct 2012
- Last updated
- 18 May 2018
- Results posted
- No
Publications
Hajjar LA, Zambolim C, Belletti A, de Almeida JP, Gordon AC, Oliveira G, Park CHL, Fukushima JT, Rizk SI, Szeles TF, Dos Santos Neto NC, Filho RK, Galas FRBG, Landoni G. Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients: The VANCS II Randomized Clinical Trial. Crit Care Med. 2019 Dec;47(12):1743-1750. doi: 10.1097/CCM.0000000000004023.
PubMed 31609774
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients
- ClinicalTrials.gov ID
- NCT01718613
- Acronym / sponsor ID
- VANCS II / NP 1079/17
- Conditions
- Septic Shock
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 31 Oct 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.
Although arginine vasopressin has been used as an additional drug in refractory shock in worldwide clinical practice, there are no prospective studies using it as a first choice therapy in patients with cancer and septic shock.
The aim of this study is assess if the use of arginine vasopressin would be more effective on treatment of septic shock in cancer patients than norepinephrine, decreasing the composite end point of mortality and organ failure in 28 days.
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 |
|---|---|---|
| Norepinephrine | Active comparator | Drug: Norepinephrine |
| Vasopressin | Active comparator | Drug: Vasopressin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Solid neoplasm needing ICU
- Septic Shock according standard criteria
Key exclusion criteria (11 listed)
- Younger than 18 years;
- Pregnancy;
- Raynaud's phenomenon, systemic sclerosis or vasospastic diathesis;
- Severe hyponatremia (Na<130mEq/L);
- Acute mesenteric ischemia;
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 |
| NorepinephrineBlinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement | Drug | Norepinephrine |
Primary outcome
28-day mortality
Time frame: 28-day from randomization
Mortality from all causes in 28-day follow-up
6 secondary outcomes
90-days mortality
Time frame: 90 days after randomization
Days alive and free of mechanical ventilation
Time frame: 28 days after randomization
Days alive and free of vasopressors
Time frame: 28 days after randomization
Days alive and free of renal replacement therapy
Time frame: 28 days after randomization
SOFA score in 24 hours
Time frame: 24 hours after ICU admission
SOFA score in 96 hours
Time frame: 96 hours after randomization
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 18 May 2018.
- Derived from this study: PubMed 31609774Hajjar LA, Zambolim C, Belletti A, de Almeida JP, Gordon AC, Oliveira G, Park CHL, Fukushima JT, Rizk SI, Szeles TF, Dos Santos Neto NC, Filho RK, Galas FRBG, Landoni G. Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients: The VANCS II Randomized Clinical Trial. Crit Care Med. 2019 Dec;47(12):1743-1750. doi: 10.1097/CCM.0000000000004023.
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Sepsis
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.
Cristiane M Zambolim, MD principal investigator
Department of Anesthesia and Critical Care, Intensive Care Unit - ICESP
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 Septic Shock, run by Instituto do Cancer do Estado de São 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 2 inclusion and 11 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 18 May 2018. 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?
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?
28-day mortality (time frame: 28-day from randomization). 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 NCT01718613, 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 18 May 2018.