- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02876406
ΔvapCO2 / Cav02 Ratio as a Prognostic Marker and Predictor of Complications After Cardiac Surgery
Using the ΔvapCO2 / Cav02 Ratio as a Prognostic Marker and Predictor of Complications After Cardiac Surgery
Studieoversikt
Status
Detaljert 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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Tomás F Fariña González, MD
- Telefonnummer: + 34 91 3303223
- E-post: tomas_scout@hotmail.com
Studer Kontakt Backup
- Navn: Fernando Martinez Sagasti, PhD
- E-post: fmsagasti@gmail.com
Studiesteder
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Madrid, Spania, 28040
- Rekruttering
- Hospital Clinico San Carlos
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Ta kontakt med:
- Tomás F Fariña González, MD
- E-post: tomas_scout@hotmail.com
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Hovedetterforsker:
- Tomás F Fariña González, MD
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
all cause mortality
Tidsramme: within the first 28 days after surgery
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within the first 28 days after surgery
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all cause intra-ICU mortality
Tidsramme: within the first 28 days after surgery
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within the first 28 days after surgery
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Ventilator days
Tidsramme: within the first 28 days after surgery
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Time that is required to extubate the patient
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within the first 28 days after surgery
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ICU stay length
Tidsramme: within the first 28 days after surgery
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within the first 28 days after surgery
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|
Hospital stay length
Tidsramme: within the first 28 days after surgery
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within the first 28 days after surgery
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Acute kidney failure
Tidsramme: within the first 28 days after surgery
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According RIFLE classification
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within the first 28 days after surgery
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Vasoactive requirements after 12 hs
Tidsramme: First 12 hs postoperative
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Noradrenaline or dobutamine requirement after 12 hs (yes/no)
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First 12 hs postoperative
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Volume infused over 12 hs (ml)
Tidsramme: First 12 hs postoperative
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First 12 hs postoperative
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Intraaortic counterpulsation balloon
Tidsramme: First 12 hs postoperative
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Need of Intraaortic baloon counterpulsation (yes/no)
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First 12 hs postoperative
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Ventricular mechanical assistance
Tidsramme: First 12 hs postoperative
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Need of ventricular mechanical assistance (yes/no)
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First 12 hs postoperative
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Renal replacement therapies
Tidsramme: within the first 28 days after surgery
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Need of renal replacement therapies (yes/no)
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within the first 28 days after surgery
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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Du W, Long Y, Wang XT, Liu DW. The Use of the Ratio between the Veno-arterial Carbon Dioxide Difference and the Arterial-venous Oxygen Difference to Guide Resuscitation in Cardiac Surgery Patients with Hyperlactatemia and Normal Central Venous Oxygen Saturation. Chin Med J (Engl). 2015 May 20;128(10):1306-13. doi: 10.4103/0366-6999.156770.
- Hu BY, Laine GA, Wang S, Solis RT. Combined central venous oxygen saturation and lactate as markers of occult hypoperfusion and outcome following cardiac surgery. J Cardiothorac Vasc Anesth. 2012 Feb;26(1):52-7. doi: 10.1053/j.jvca.2011.07.021. Epub 2011 Sep 15.
- Habicher M, von Heymann C, Spies CD, Wernecke KD, Sander M. Central Venous-Arterial pCO2 Difference Identifies Microcirculatory Hypoperfusion in Cardiac Surgical Patients With Normal Central Venous Oxygen Saturation: A Retrospective Analysis. J Cardiothorac Vasc Anesth. 2015;29(3):646-55. doi: 10.1053/j.jvca.2014.09.006. Epub 2015 Jan 6.
- Robin E, Futier E, Pires O, Fleyfel M, Tavernier B, Lebuffe G, Vallet B. Central venous-to-arterial carbon dioxide difference as a prognostic tool in high-risk surgical patients. Crit Care. 2015 May 13;19(1):227. doi: 10.1186/s13054-015-0917-6.
- 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.
- Ospina-Tascon GA, Umana M, Bermudez W, Bautista-Rincon DF, Hernandez G, Bruhn A, Granados M, Salazar B, Arango-Davila C, De Backer D. Combination of arterial lactate levels and venous-arterial CO2 to arterial-venous O 2 content difference ratio as markers of resuscitation in patients with septic shock. Intensive Care Med. 2015 May;41(5):796-805. doi: 10.1007/s00134-015-3720-6. Epub 2015 Mar 20.
- Balzer F, Sander M, Simon M, Spies C, Habicher M, Treskatsch S, Mezger V, Schirmer U, Heringlake M, Wernecke KD, Grubitzsch H, von Heymann C. High central venous saturation after cardiac surgery is associated with increased organ failure and long-term mortality: an observational cross-sectional study. Crit Care. 2015 Apr 16;19(1):168. doi: 10.1186/s13054-015-0889-6.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- C.P. - C.I. 16/359-E
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