NCT02053675

Brief Summary

Vasopressin is a vasopressor used in patients with septic shock. However, its systemic hemodynamic effects and its microcirculation effects are not completely known and understood. This study aimed to evaluate the effect of exogenous vasopressin on sublingual microcirculation using the sidestream dark field technique and to correlate it with its systemic effects. To this prospective interventional study, patients with septic shock were included during the first 48 hours of use of catecholamine vasopressors, admitted to the intensive care unit of a university hospital. Vasopressin was administered at 0.04 U / min for one hour. Systemic hemodynamic measurements were obtained immediately before and 1 hour after vasopressin. In addition, images of sublingual microcirculation were collected through sidestream dark field technology. Further analysis with specific software was done after.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

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

Study Start

First participant enrolled

May 1, 2008

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2013

Completed
8 months until next milestone

First Posted

Study publicly available on registry

February 4, 2014

Completed
Last Updated

February 4, 2014

Status Verified

May 1, 2010

Enrollment Period

4.9 years

First QC Date

May 28, 2013

Last Update Submit

January 31, 2014

Conditions

Septic Shock

Keywords

septic shockvasopressinmicrocirculationtissue oxygenationvasopressorshemodynamics

Outcome Measures

Primary Outcomes (1)

  • The primary objective of this study was to evaluate the effect of vasopressin infusion in microcirculation of septic shock patients

    Significant changes in microcirculatory parameters - MFI (absolute number), TVD (mm/mm2), PVD (mm/mm2), PPV (%), HI (%)

    one hour after vasopressin initiation

Secondary Outcomes (1)

  • The secondary objectives were to evaluate the effects of vasopressin on macrocirculation, and correlate potential microcirculatory effects related to its use, with baseline systemic circulation and microcirculation.

    one hour after vasopressin initiation

Study Arms (1)

Vasopressin

OTHER
Drug: Vasopressin infusion

Interventions

Vasopressin infusionDRUG
Vasopressin

Eligibility Criteria

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

You may qualify if:

  • Patients over 18 years
  • Septic shock using adrenergic vasopressors for less than 48 hours
  • Arterial catheter and pulmonary artery catheter with semi measurement of cardiac output by thermodilution (Vigilance, Edwards Lifesciences, Irvine, CA, USA) inserted
  • Signed consent declaration

You may not qualify if:

  • Acute coronary disease
  • Suspected or confirmed acute mesenteric ischemia
  • Severe hyponatremia (Na + \<130 mmol / L)
  • Raynaud's phenomenon
  • Sclerodermia
  • Pregnancy
  • Technical difficulties to capture videomicroscopy with sublingual SDF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital São Paulo

São Paulo, São Paulo/SP, 04024900, Brazil

Location

Related Publications (1)

  • Nascente APM, Freitas FGR, Bakker J, Bafi AT, Ladeira RT, Azevedo LCP, Lima A, Machado FR. Microcirculation improvement after short-term infusion of vasopressin in septic shock is dependent on noradrenaline. Clinics (Sao Paulo). 2017 Dec;72(12):750-757. doi: 10.6061/clinics/2017(12)06.

    PMID: 29319721DERIVED

MeSH Terms

Conditions

Shock, SepticDiabetes Insipidus

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 28, 2013

First Posted

February 4, 2014

Study Start

May 1, 2008

Primary Completion

April 1, 2013

Last Updated

February 4, 2014

Record last verified: 2010-05

Locations

BR(1)