- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT01532505
Effect of Vasopressin on Tissue Oxygen Saturation in Cardiac Surgery Patients During Cardiopulmonary Bypass
A Randomized Study Comparing Low Dose Vasopressin Infusion or Placebo on Near Infrared Spectroscopy Tissue Oxygen Saturation and the Vascular Occlusion Test in Cardiac Surgery Patients During Cardiopulmonary Bypass: A Pilot Study
Przegląd badań
Status
Szczegółowy opis
In our double blind randomized study 40 patients undergoing cardiac surgery will be randomly divided in two groups. The group A who will be infused with 2 IU/hr. vasopressin and the group B who will be infused with normal saline (placebo) intraoperatively starting at the time we give I.V. Heparin, throughout CPB and infusion will be ended when we give the Protamine after coming off bypass. VOTs will be measured at the following time points: Pre-induction of anesthesia, post-induction of anesthesia and at 30 minute intervals during the cardiopulmonary bypass. And we will select cases that are expected to have a longer CPB time such as Redo CABG, CABG + valve replacement, double valve replacement, Bentall procedure and Mitral valve repair with mini thoracotomy.
Measurements of mean artery pressure (MAP), central venous pressure (CVP), ejection fracture (EF), heart rate (HR), mean pulmonary artery pressure (MPAP), cardiac index (CI) will be performed before, during, and after the operation. The requirements of catecholamine support (eg. phenylephrine, epinephrine, vasopressin, norepinephrine, and dopamine) during CPB and for first 24 hours postoperatively, urine-output, blood-loss, and the requirements in blood, plasma and platelets for the first 24 hours will be included in the data collected.
The purpose of the present study is to quantify the micro-oxygenation parameters in patients undergoing cardiac surgery with CPB, to investigate the relationship of micro-oxygenation and macro-perfusion parameters, to investigate the relationship of NIRS parameters and to evaluate the association between micro-oxygenation parameters and outcome using VOT and comparing the degree of falling of re-perfusion slope.
We hypothesize that the administration of a low dose vasopressin will reduce both the incidence and severity of vasoplegia and it will maintain the normal vasomotor reactivity during cardiopulmonary bypass and this will reduce the total requirements of alpha-adrenergic agonists specially Phenylephrine. That will reduce the risks of the use of high dose of Phenylephrine and other inotropes, such as gut ischemia and end organ damage.
Vascular Occlusion Test (VOT)
- After the tissue oximetry probe is applied to the skin the oximeter machine records a baseline value.
- A pneumatic cuff (blood pressure cuff) is placed over the brachial artery of the same arm above the elbow and inflated to 50 mmHg above systolic blood pressure. The cuff remains inflated for 5 minutes. The oximeter machine is continuously recording StO2 values and other pertinent technical information such as quality of the signal and events marked by the user.
- After 5 minutes the cuff is quickly deflated and StO2 measurements continue to be recorded until back to baseline.
- VOTs will be measured at the following time points:
- Pre-induction of anesthesia
- Post-induction of anesthesia
- At 30 minute intervals during the cardiopulmonary bypass
Several measurements and calculations will be made from the recorded data:
- Baseline tissue oxygen saturation (StO2baseline) at time (t) = 0
- Lowest StO2 reached after vascular occlusion (StO2nadir) and at what time
- Occlusion slope: defined as = (StO2baseline - StO2nadir/tbaseline - tnadir)
- After cuff release, time at which baseline StO2 was reached (StO2recovery)
- Reperfusion slope: defined as = (StO2recovery - StO2nadir/trecovery - tnadir)
- ∆StO2: defined as = (StO2peak - StO2baseline)
- Peak StO2 reached after cuff release and at what time
Measurements of mean artery pressure (MAP), central venous pressure (CVP), ejection fracture (EF), heart rate (HR), mean pulmonary artery pressure (MPAP), cardiac index (CI) will be performed before, during, and after the operation. The requirements of catecholamine support (eg. phenylephrine, epinephrine, vasopressin, norepinephrine, dopamine) during CPB and for first 24 hours postoperatively, urine-output, blood-loss, and the requirements in blood, plasma and platelets for the first 24 hours will be included in the data collected.
Typ studiów
Zapisy (Oczekiwany)
Kontakty i lokalizacje
Lokalizacje studiów
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Ontario
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London, Ontario, Kanada, N6A 5A5
- University Hospital, LHSC
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
- Adult, elective cardiac surgery patients with the use of cardiopulmonary bypass (CPB)
Exclusion Criteria:
- Age less than 18 years
- Contraindication to pneumatic cuff inflation (arteriovenous fistula, previous mastectomy, injury to arm)
- Pregnancy
- Significant peripheral vascular disease of the arms*
- Emergency surgery
- Uncured cancer during chemotherapy
- Lack of informed consent
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: Kontrola przypadków
- Perspektywy czasowe: Spodziewany
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
VOT assessment of microcirculation
Ramy czasowe: day one
|
change in reperfusion slope of VOT will be assessed each 30 min during CPB and compared between vasopressin and placebo patients
|
day one
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: MOHAMED ISMAIL, MD,MSc, London HSC
- Dyrektor Studium: JOHN MURKIN, MD, FRCPC, London HSC
Publikacje i pomocne linki
Publikacje ogólne
- Peripheral Tissue Oxygen Saturation (SaO2) Monitoring and the Vascular Occlusion Test in Cardiac Surgery: A Pilot Study. Smith R, Murkin J, Granton J, Guo LR, McKenzie FN, Min F, Zhang R. ASA Chicago, Oct 15-19, 2011, Anesthesiology 2011 A278.
- Papadopoulos G, Sintou E, Siminelakis S, Koletsis E, Baikoussis NG, Apostolakis E. Perioperative infusion of low- dose of vasopressin for prevention and management of vasodilatory vasoplegic syndrome in patients undergoing coronary artery bypass grafting-A double-blind randomized study. J Cardiothorac Surg. 2010 Mar 28;5:17. doi: 10.1186/1749-8090-5-17.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 18511
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