NCT01718613

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2012

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 18, 2018

Status Verified

May 1, 2018

Enrollment Period

1.3 years

First QC Date

October 29, 2012

Last Update Submit

May 16, 2018

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

  • 28-day mortality

    Mortality from all causes in 28-day follow-up

    28-day from randomization

Secondary Outcomes (6)

  • 90-days mortality

    90 days after randomization

  • Days alive and free of mechanical ventilation

    28 days after randomization

  • Days alive and free of vasopressors

    28 days after randomization

  • Days alive and free of renal replacement therapy

    28 days after randomization

  • SOFA score in 24 hours

    24 hours after ICU admission

  • +1 more secondary outcomes

Study Arms (2)

Norepinephrine

ACTIVE COMPARATOR
Drug: Norepinephrine

Vasopressin

ACTIVE COMPARATOR
Drug: Vasopressin

Interventions

VasopressinDRUG

Blinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure \<65 mmHg after fluid replacement

Vasopressin
NorepinephrineDRUG

Blinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure \<65 mmHg after fluid replacement

Norepinephrine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Solid neoplasm needing ICU
  • Septic Shock according standard criteria

You may not qualify if:

  • Younger than 18 years;
  • Pregnancy;
  • Raynaud's phenomenon, systemic sclerosis or vasospastic diathesis;
  • Severe hyponatremia (Na\<130mEq/L);
  • Acute mesenteric ischemia;
  • Acute myocardial infarction;
  • Cardiogenic shock;
  • Current use of vasopressor before randomization
  • Expected ICU stay less than 24 hours
  • Enrolled in another study;
  • Refusal to consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto do Cancer do Estado de Sao Paulo

São Paulo, Sao Paulo/SP, 01246000, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 31609774DERIVED

MeSH Terms

Conditions

Shock, Septic

Interventions

VasopressinsNorepinephrine

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Cristiane M Zambolim, MD

    Department of Anesthesia and Critical Care, Intensive Care Unit - ICESP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 29, 2012

First Posted

October 31, 2012

Study Start

November 1, 2012

Primary Completion

March 1, 2014

Study Completion

May 1, 2018

Last Updated

May 18, 2018

Record last verified: 2018-05

Locations

BR(1)