NCT01178866

Brief Summary

Evaluate less employed markers of tissue hypoperfusion as venoarterial carbon dioxide partial pressure difference (ΔPCO2) and estimated respiratory quotient (eRQ) combined to other classically studied markers as predictive factors of complicated clinical course after cardiac surgery in patients with left ventricular dysfunction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2006

Typical duration for all trials

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

January 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2010

Completed
Last Updated

August 10, 2010

Status Verified

January 1, 2008

Enrollment Period

2 years

First QC Date

August 9, 2010

Last Update Submit

August 9, 2010

Conditions

Left Ventricular DysfunctionCoronary Artery Bypass SurgeryTissue Hypoperfusion

Keywords

thoracic surgerymyocardial revascularizationleft ventricular dysfunctiontissue perfusionprognosis

Outcome Measures

Primary Outcomes (1)

  • Complicated clinical course after coronary artery bypass surgery

    Complicated clinical course defined as death within the first 30 days after surgery or ICU stay more than 4 days.

    within the first 30 days after surgery

Study Arms (1)

Clinical course

complicated course group (death within 30 days after surgery or ICU stay \> 4 days) and uncomplicated course group (ICU stay ≤ 4 days).

Eligibility Criteria

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

Adults undergoing coronary artery bypass surgery requiring the use of CPB

You may qualify if:

  • adults
  • left ventricular dysfunction (ejection fraction \< 50%)
  • patients undergoing coronary artery bypass surgery requiring the use of Cardiopulmonary Bypass (CPB)

You may not qualify if:

  • renal failure (creatinine clearance lower than 40 ml/min/m2),
  • hepatic dysfunction
  • endocrinologic disorders
  • pulmonary disease
  • uncontrolled diabetes mellitus
  • a history of fever or infection within the week before surgery
  • previous anemia (hemoglobin ≤ 10.0 g/dL)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Institute, Hospital of Clinics, São Paulo University Medical School

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (5)

  • Mekontso-Dessap A, Castelain V, Anguel N, Bahloul M, Schauvliege F, Richard C, Teboul JL. Combination of venoarterial PCO2 difference with arteriovenous O2 content difference to detect anaerobic metabolism in patients. Intensive Care Med. 2002 Mar;28(3):272-7. doi: 10.1007/s00134-002-1215-8. Epub 2002 Feb 8.

    PMID: 11904655BACKGROUND

  • Ranucci M, De Toffol B, Isgro G, Romitti F, Conti D, Vicentini M. Hyperlactatemia during cardiopulmonary bypass: determinants and impact on postoperative outcome. Crit Care. 2006;10(6):R167. doi: 10.1186/cc5113.

    PMID: 17134504BACKGROUND

  • Ranucci M, Isgro G, Romitti F, Mele S, Biagioli B, Giomarelli P. Anaerobic metabolism during cardiopulmonary bypass: predictive value of carbon dioxide derived parameters. Ann Thorac Surg. 2006 Jun;81(6):2189-95. doi: 10.1016/j.athoracsur.2006.01.025.

    PMID: 16731152BACKGROUND

  • Meregalli A, Oliveira RP, Friedman G. Occult hypoperfusion is associated with increased mortality in hemodynamically stable, high-risk, surgical patients. Crit Care. 2004 Apr;8(2):R60-5. doi: 10.1186/cc2423. Epub 2004 Jan 12.

    PMID: 15025779BACKGROUND

  • Topkara VK, Cheema FH, Kesavaramanujam S, Mercando ML, Cheema AF, Namerow PB, Argenziano M, Naka Y, Oz MC, Esrig BC. Coronary artery bypass grafting in patients with low ejection fraction. Circulation. 2005 Aug 30;112(9 Suppl):I344-50. doi: 10.1161/CIRCULATIONAHA.104.526277.

    PMID: 16159844BACKGROUND

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Ventricular DysfunctionHeart DiseasesCardiovascular Diseases

Study Officials

  • Thiana Yamaguti, PhD

    Heart Institute, Hospital of Clinics, São Paulo University Medical School

    PRINCIPAL INVESTIGATOR

  • José Otávio C. Auler Júnior, PhD/Chairman

    Heart Institute, Hospital of Clinics, São Paulo University Medical School

    STUDY CHAIR

  • Marilde A. Piccioni, PhD

    Heart Institute, Hospital of Clinics, São Paulo University Medical School

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 9, 2010

First Posted

August 10, 2010

Study Start

January 1, 2006

Primary Completion

January 1, 2008

Study Completion

March 1, 2008

Last Updated

August 10, 2010

Record last verified: 2008-01

Locations

BR(1)