NCT03591029

Brief Summary

The study is about comparing blood samples obtained from the superior vena cava and the pulmonary artery. The investigators will compare the values of PCO2 and PO2 from these two sites, in order to see if exists a PCO2 gap and a PO2 gap, different from zero. Moreover the investigators want to find out if these gaps are related with changes in the cardiac output, the hematocrit or if they can predict post operative dysfunctions. Blood samples will be taken at six different times as scheduled by the protocol. Along with the two venous blood samples, an arterial blood sample will be taken too, from a radial of femoral artery catheter.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

July 2, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

July 19, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2019

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

July 2, 2018

Last Update Submit

July 30, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • PCO2 gap changes

    See if exists a PCO2 pa-svc gap different from zero in patients undergoing cardiac surgery

    two days

  • PO2 gap changes

    See if exists a PCO2 pa-svc gap different from zero in patients undergoing cardiac surgery

    two days

Interventions

blood samples will be obtained from the superior vena cava (via centra venous catheter), from the pulmonary artery (via Swan Ganz catheter), and from a radial or femoral artery catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Will be enrolled adult patients only , eligible for cardiac surgery (CABG, valvular replacement, aortic surgery) with extra corporeal circulation.

You may qualify if:

  • age \> 18 years
  • patient undergoing cardiac surgery with extracorporeal circulation
  • hemodynamic monitoring with a central venous catheter and a Swan Ganz catheter placed in the internal left giugulare vein

You may not qualify if:

  • severe tricuspid insufficiency
  • EF \< 50%
  • SOFA score \>1 in at least one of all the criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

catholic University of the sacred Heart

Rome, 00168, Italy

Location

Francesca Bevilacqua

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Heart Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 2, 2018

First Posted

July 18, 2018

Study Start

July 19, 2018

Primary Completion

July 23, 2019

Study Completion

July 24, 2019

Last Updated

July 31, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations