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ΔvapCO2 / Cav02 Ratio as a Prognostic Marker and Predictor of Complications After Cardiac Surgery

25. oktober 2016 opdateret af: Tomás Francisco Fariña González, Hospital San Carlos, Madrid

Using the ΔvapCO2 / Cav02 Ratio as a Prognostic Marker and Predictor of Complications After Cardiac Surgery

This study evaluates the usefulness of the ΔvapCO2 / Cav02 ratio to predict complications after elective cardiac surgery, comparing it with others markers such as lactate, arteriovenous CO2 difference (ΔvapCO2) and would try to developed a new predictive score for postoperative complications.

Studieoversigt

Detaljeret beskrivelse

Cardiac surgery is widely used to solve valvular or coronary problems and often requires the use of cardiopulmonary bypass or extracorporeal circulation (EC).

The EC itself produces a series of changes in the macro- and microcirculation hemodynamic and physiological consequences in the hours following surgery that can be difficult to analyze.

During postoperatively management, different monitoring methods are used to optimize different hemodynamic and analytical variables.

Sometimes, monitored variables are corrected but the patient still develops complications such as kidney failure, prolonged mechanical ventilation or even death. In fact, it is not well known either if it is sufficient to correct the variables called "macrodynamics " such as mean arterial pressure (MAP) , stroke volume (SV), pulmonary artery occlusion pressure (PCWP) and cardiac index (CI) or if it is necessary to correct other "micro-dynamics" variables like lactate, to achieve a certain central venous oxygen saturation (ScvO2) or arteriovenous CO2 difference(ΔvapCO2).

In tissue hypoxia, damping of excess protons by bicarbonate increase CO2 production; therefore the relationship between CO2 production and oxygen consumption (VCO2/VO2 ratio or respiratory quotient) increases. This ratio can be simplified relating ΔvapCO2 and O2 content arteriovenous difference (ΔvapCO2 / Cav02 ratio). In shock, anaerobic metabolism is one of the primary energy source. In this situation, ΔvapCO2 / Cav02 is > 1.

The evolution of the ΔvapCO2 / Cav02 ratio and its association with prognosis have nnot been studied yet after cardiac surgery.

The study's objectives are:

  • to describe ΔvapCO2 / Cav02 ratios kinetics compared to lactate and other biochemical markers (troponin I, BE) in the first 12 hours after cardiac surgery.
  • define if ΔvapCO2 / Cav02 ratio> 1 after 6 hours of adequate postsurgical resuscitation correlates with worse prognosis in patients after cardiac surgery.
  • develop a new prognostic score for postoperative complication that includes ΔvapCO2 / Cav02 ratio.

Blood gases and drawn from a central venous and arterial lines. pCO2, O2 content, lactate are analyzed at 0, 2, 6 and 12 hs. Macrodynamic variables are also collected, as well as, the need of extracorporeal support techniques.

Patients would be followed for the next 28 days after surgery.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

150

Kontakter og lokationer

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Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

      • Madrid, Spanien, 28040
        • Rekruttering
        • Hospital Clinico San Carlos
        • Kontakt:
        • Ledende efterforsker:
          • Tomás F Fariña González, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Patients undergoing elective cardiac surgery in an university hospital that would be followed during the postoperative time in the Cardiovascular Intensive Care Unit.

Beskrivelse

Inclusion Criteria:

  • 18 years old or more
  • given informed consent
  • elective cardiac surgery
  • tip of a central venous catheter correctly positioned (superior vena cava or right atria)
  • arterial catheter correctly positioned

Exclusion criteria:

  • pregnancy

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
all cause mortality
Tidsramme: within the first 28 days after surgery
within the first 28 days after surgery
all cause intra-ICU mortality
Tidsramme: within the first 28 days after surgery
within the first 28 days after surgery
Ventilator days
Tidsramme: within the first 28 days after surgery
Time that is required to extubate the patient
within the first 28 days after surgery
ICU stay length
Tidsramme: within the first 28 days after surgery
within the first 28 days after surgery
Hospital stay length
Tidsramme: within the first 28 days after surgery
within the first 28 days after surgery
Acute kidney failure
Tidsramme: within the first 28 days after surgery
According RIFLE classification
within the first 28 days after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Vasoactive requirements after 12 hs
Tidsramme: First 12 hs postoperative
Noradrenaline or dobutamine requirement after 12 hs (yes/no)
First 12 hs postoperative
Volume infused over 12 hs (ml)
Tidsramme: First 12 hs postoperative
First 12 hs postoperative
Intraaortic counterpulsation balloon
Tidsramme: First 12 hs postoperative
Need of Intraaortic baloon counterpulsation (yes/no)
First 12 hs postoperative
Ventricular mechanical assistance
Tidsramme: First 12 hs postoperative
Need of ventricular mechanical assistance (yes/no)
First 12 hs postoperative
Renal replacement therapies
Tidsramme: within the first 28 days after surgery
Need of renal replacement therapies (yes/no)
within the first 28 days after surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2016

Primær færdiggørelse (Forventet)

1. september 2017

Studieafslutning (Forventet)

1. oktober 2017

Datoer for studieregistrering

Først indsendt

9. august 2016

Først indsendt, der opfyldte QC-kriterier

18. august 2016

Først opslået (Skøn)

23. august 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. oktober 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. oktober 2016

Sidst verificeret

1. oktober 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • C.P. - C.I. 16/359-E

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

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Kliniske forsøg med Postoperative komplikationer

3
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