- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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Madrid, Spanien, 28040
- Rekrytering
- Hospital Clinico San Carlos
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Kontakt:
- Tomás F Fariña González, MD
- E-post: tomas_scout@hotmail.com
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Huvudutredare:
- Tomás F Fariña González, MD
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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all cause mortality
Tidsram: 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
Tidsram: within the first 28 days after surgery
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within the first 28 days after surgery
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Ventilator days
Tidsram: within the first 28 days after surgery
|
Time that is required to extubate the patient
|
within the first 28 days after surgery
|
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ICU stay length
Tidsram: within the first 28 days after surgery
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within the first 28 days after surgery
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|
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Hospital stay length
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Vasoactive requirements after 12 hs
Tidsram: 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)
Tidsram: First 12 hs postoperative
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First 12 hs postoperative
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Intraaortic counterpulsation balloon
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- C.P. - C.I. 16/359-E
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