- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01178866
Laboratory Outcome Predictors in Coronary Surgery
Markers of Tissue Perfusion as Predictors of Complicated Evolution in Patients With Left Ventricular Dysfunction Submitted to Coronary Artery Bypass Surgery
Studieöversikt
Status
Detaljerad beskrivning
Patients with left ventricular dysfunction are more susceptible to tissue hypoperfusion and presents more frequently both low cardiac output syndrome and systemic inflammatory response, what results in prolonged stay in intensive care unit (ICU), and higher mortality rates when compared to patients with normal ventricular function.
The early prediction of prolonged ICU stay through the detection of tissue hypoperfusion may improve the management of care and decrease morbidity of this particular group of patients. However, classic markers of tissue hypoxia as central venous saturation, base excess, lactate may not be predictors of outcome in cardiac surgery patients with left ventricular dysfunction.
The question addressed in this study is if less employed markers of tissue hypoperfusion as as venoarterial carbon dioxide partial pressure difference (ΔPCO2) and estimated respiratory quotient (eRQ) have predictive value of prolonged ICU stay in patients with left ventricular dysfunction submitted to coronary artery bypass surgery.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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São Paulo, Brasilien, 05403-000
- Heart Institute, Hospital of Clinics, São Paulo University Medical School
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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:
- adults
- left ventricular dysfunction (ejection fraction < 50%)
- patients undergoing coronary artery bypass surgery requiring the use of Cardiopulmonary Bypass (CPB)
Exclusion Criteria:
- 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)
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Clinical course
complicated course group (death within 30 days after surgery or ICU stay > 4 days) and uncomplicated course group (ICU stay ≤ 4 days).
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Complicated clinical course after coronary artery bypass surgery
Tidsram: within the first 30 days after surgery
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Complicated clinical course defined as death within the first 30 days after surgery or ICU stay more than 4 days.
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within the first 30 days after surgery
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Thiana Yamaguti, PhD, Heart Institute, Hospital of Clinics, São Paulo University Medical School
- Studiestol: José Otávio C. Auler Júnior, PhD/Chairman, Heart Institute, Hospital of Clinics, São Paulo University Medical School
- Studierektor: Marilde A. Piccioni, PhD, Heart Institute, Hospital of Clinics, São Paulo University Medical School
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
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
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HC517/04
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