NCT01505231

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2012

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 6, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

February 12, 2013

Status Verified

February 1, 2013

Enrollment Period

1.1 years

First QC Date

January 2, 2012

Last Update Submit

February 11, 2013

Conditions

Shock

Keywords

Shocknorepinephrinevasopressincardiac surgery

Outcome Measures

Primary Outcomes (1)

  • 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)

    30 days

Secondary Outcomes (5)

  • Hemodynamic effects

    28 days

  • occurence of adverse events and safety

    28 days

  • Time on mechanical ventilation

    30 days

  • Incidence of infecction

    30-days

  • Length of ICU and Hospital stay

    90 days

Study Arms (2)

Norepinephrine group

ACTIVE COMPARATOR

Blinded norepinephrine

Drug: Norepinephrine

Vasopressin Group

ACTIVE COMPARATOR

Blinded vasopressin

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 Group
NorepinephrineDRUG

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

Norepinephrine group

Eligibility Criteria

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

You may qualify if:

  • need vasopressor support

You may not qualify if:

  • 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;
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto do Coração

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

Related Publications (1)

  • 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.

    PMID: 25947955DERIVED

MeSH Terms

Conditions

ShockDiabetes Insipidus

Interventions

VasopressinsNorepinephrine

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System Diseases

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

Central Study Contacts

Ludhmila Hajjar, MD, PhD

CONTACT

55-11-93194401ludhmila@usp.br

Study Design

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

Study Record Dates

First Submitted

January 2, 2012

First Posted

January 6, 2012

Study Start

January 1, 2012

Primary Completion

February 1, 2013

Study Completion

May 1, 2013

Last Updated

February 12, 2013

Record last verified: 2013-02

Locations

BR(1)