Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients

NCT ID: NCT01718613

Last Updated: 2018-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2018-05-31

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.

Conditions

Septic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Norepinephrine

Group Type: ACTIVE_COMPARATOR

Norepinephrine

Intervention Type: DRUG

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

Vasopressin

Group Type: ACTIVE_COMPARATOR

Vasopressin

Intervention Type: DRUG

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

Interventions

Vasopressin

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

Intervention Type: DRUG

Norepinephrine

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Solid neoplasm needing ICU
• Septic Shock according standard criteria

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Cristiane Maciel Zambolim

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cristiane M Zambolim, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Instituto do Cancer do Estado de Sao Paulo

São Paulo, Sao Paulo/SP, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 31609774 (View on PubMed)

Other Identifiers

NP 1079/17

Identifier Type: -

Identifier Source: org_study_id