NCT02328846

Brief Summary

Evaluation of the microcirculation is currently limited. Continual assessment of the tissue carbon dioxide-arterial carbon dioxide (PtC02-aCO2) offers a new, novel and noninvasive method of determining the state of the microcirculation. The investigators will apply two non-invasive devices, the Braedius sidesteam darkfield microscopy (SDF) microscopy device to the sublingual circulation and the transcutaneous PtC02 probe to the forehead in subjects undergoing cardiac surgery with cardiopulmonary bypass. The PtC02-aCO2 gradient will be determined and correlated with the videomicroscopic images of the sublingual microcirculation. Thereafter the incidence of postoperative organ failure and acute kidney injury will be determined and correlated with PtC02-arterial CO2 gradient and videomicroscopic images. Data will be analyzed by standard descriptive statistical methods.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2018

Typical duration for all trials

Status
withdrawn

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

December 18, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
3 years until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

October 22, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

December 18, 2014

Last Update Submit

October 18, 2018

Conditions

Bypass Complications

Outcome Measures

Primary Outcomes (1)

  • Postoperative SOFA score

    Participants will be followed for the duration of ICU stay, an expected average of 1 weeks

Secondary Outcomes (1)

  • Postoperative Kidney Disease Improving Global Outcome (KDIGO) class

    Participants will be followed for the duration of ICU stay, an expected average of 1 weeks

Eligibility Criteria

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

Subjects undergoing cardiac surgery with cardiopulmonary bypass

You may qualify if:

  • Age \> 18 years
  • Elective cardiac surgery
  • Must be able to read and speak English

You may not qualify if:

  • Subjects unable/unwilling to give informed consent
  • Emergency surgery
  • Age \< 18 years
  • Pregnant females-self reported
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Asfar P, Meziani F, Hamel JF, Grelon F, Megarbane B, Anguel N, Mira JP, Dequin PF, Gergaud S, Weiss N, Legay F, Le Tulzo Y, Conrad M, Robert R, Gonzalez F, Guitton C, Tamion F, Tonnelier JM, Guezennec P, Van Der Linden T, Vieillard-Baron A, Mariotte E, Pradel G, Lesieur O, Ricard JD, Herve F, du Cheyron D, Guerin C, Mercat A, Teboul JL, Radermacher P; SEPSISPAM Investigators. High versus low blood-pressure target in patients with septic shock. N Engl J Med. 2014 Apr 24;370(17):1583-93. doi: 10.1056/NEJMoa1312173. Epub 2014 Mar 18.

    PMID: 24635770RESULT

  • De Backer D, Creteur J, Preiser JC, Dubois MJ, Vincent JL. Microvascular blood flow is altered in patients with sepsis. Am J Respir Crit Care Med. 2002 Jul 1;166(1):98-104. doi: 10.1164/rccm.200109-016oc.

    PMID: 12091178RESULT

  • Sakr Y, Dubois MJ, De Backer D, Creteur J, Vincent JL. Persistent microcirculatory alterations are associated with organ failure and death in patients with septic shock. Crit Care Med. 2004 Sep;32(9):1825-31. doi: 10.1097/01.ccm.0000138558.16257.3f.

    PMID: 15343008RESULT

  • Vallee F, Mateo J, Dubreuil G, Poussant T, Tachon G, Ouanounou I, Payen D. Cutaneous ear lobe Pco(2) at 37 degrees C to evaluate microperfusion in patients with septic shock. Chest. 2010 Nov;138(5):1062-70. doi: 10.1378/chest.09-2690. Epub 2010 May 14.

    PMID: 20472858RESULT

  • Vallee F, Vallet B, Mathe O, Parraguette J, Mari A, Silva S, Samii K, Fourcade O, Genestal M. Central venous-to-arterial carbon dioxide difference: an additional target for goal-directed therapy in septic shock? Intensive Care Med. 2008 Dec;34(12):2218-25. doi: 10.1007/s00134-008-1199-0. Epub 2008 Jul 8.

    PMID: 18607565RESULT

Study Officials

  • Bhiken I Naik, M.B.B.Ch

    University of Virginia

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

December 18, 2014

First Posted

December 31, 2014

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

February 1, 2020

Last Updated

October 22, 2018

Record last verified: 2018-10