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van CCT (UK)


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van CCT (UK)


The effects of high oxygen levels on circulation during and after cardiac surgery.


- candidate number16297
- NTR NumberNTR4375
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-jan-2014
- Secondary IDsNL43882.029.13 
- Public TitleThe effects of high oxygen levels on circulation during and after cardiac surgery.
- Scientific TitleCardiovascular effects of hyperoxia during and after CABG surgery.
- ACRONYM
- hypothesisWe hypothesize that hyperoxia during and post CABG surgery has unfavourable effects on hemodynamics, microcirculation, and ischemia/reperfusion injury, due to increased oxidative stress (ROS) affecting endothelium-derived vaso-active factors.
- Healt Condition(s) or Problem(s) studiedHypoxia, Cardiac surgery, Myocardial ischemia, Oxidative stress
- Inclusion criteria-Age > 18 years -Non-emergent CABG surgery -Hb > 7.5 mmol/l -BSA > 1.9 m2
- Exclusion criteria-Emergency surgery -Combined cardiac surgery (heart valve combined with CABG surgery) -Off-pump-CABG -Presence of pre/perioperative intra-aortic balloon pump -Medical history positive for COPD
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2013
- planned closingdate1-nov-2014
- Target number of participants50
- InterventionsIn this study we compare different oxygen levels. We will investigate current practice ( 1, 2; group I) with titrated oxygen levels (group II). group I: target PaO2 on CBP during aortic clamp time 200 每 220 mmHg, PaO2 at ICU of 130-150 mm Hg group II: : After intubation FiO2 will be decreased to 40% (provided that O2 saturation remains > 96%). Target PaO2 on CBP during aortic clamp tima 130 每 150 mmHg, PaO2 at ICU 80 每 100 mmHg
- Primary outcomeMyocardial damage (CK-MB, hs-troponine-T)
- Secondary outcomeHemodynamic parameters: SVRI and C.I. microcirculation oxidative stress tissue/organ perfusion clinical endpoints (duration of mechanical ventilation, length of stay, mortality).
- TimepointsAt baseline, immediately after operation, 6 and 12 hours after operation.
- Trial web site
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES A.M.E. Spoelstra - de Man
- CONTACT for SCIENTIFIC QUERIES A.M.E. Spoelstra - de Man
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Institute for Cardiovascular Research
- Publications
- Brief summaryRationale: Although the deleterious effects of hypoxia are well known, most physicians are less aware of the potential harmfull effect of hyperoxia. To avoid hypoxia, the tendency to supply extra oxygen to patients is widespread. Increasing evidence shows that hyperoxia has important circulatory effects, with decreased cardiac output (CO) and increased systemic vascular resistance (SVR), resulting in increased infarct size and increased mortality after myocardial infarction and cardiac arrest. The underlying mechanisms are unknown, but could relate to increased formation of reactive oxygen species (ROS), which not only causes vasoconstriction, but also other untoward effects, such as reperfusion damage. Hyperoxia is frequently, >20% of the mechanical ventilation time, encountered in the Intensive Care. Patients who underwent a coronary bypass graft operation (CABG) may be especially vulnerable to the detrimental cardiovascular effects of hyperoxia because of fluctuations in cardiac function due to other causes (such as blood loss and fluid shifts) post-surgery. However, many physicians still feel that increased arterial oxygen pressure (PaO2) represents a salutary oxygen reserve not only post-surgery but also during cardiopulmonary bypass (CPB). PaO2 measurements of >200 to 300 mmHg during CPB are no exception, as confirmed by our own pilot data. Therefore, we chose to investigate the cardiovascular effects of hyperoxia in patients during and after CABG surgery together with the proposed mechanisms by which hyperoxia exerts its effects. We will compare standard patient care, using supra-normal PaO2 levels, with oxygen levels titrated to a (near) normal physiological range. We hypothesize that hyperoxia during and post CABG surgery has unfavourable effects on hemodynamics, microcirculation, and ischemia/reperfusion injury, due to increased oxidative stress (ROS) affecting endothelium-derived vaso-active factors. Objectives: 1. To study the effect of different target PaO2's on myocardial injury, hemodynamics, microcirculation and organ perfusion injury in CABG patients. 2. To study underlying mechanisms of hyperoxia by determining differences in oxidative stress response between the hyperoxic patients and the normoxemic groups. Study design: Randomized, prospective clinical trial Study population: Patients undergoing CABG surgery Intervention: We will investigate current practice ( 1, 2; group I) with (near) normal oxygen levels (group II). group I: target PaO2 on CBP during aortic clamp time 200 每 220 mmHg, PaO2 at ICU of 130-150 mm Hg group II: : After intubation FiO2 will be decreased to 40% (provided that O2 saturation remains > 96%). Target PaO2 on CBP during aortic clamp time 130 每 150 mmHg, PaO2 at ICU 80 每 100 mmHg Primary endpoints: Myocardial damage (CK-MB, hs-troponine-T) Secondary endpoints: Hemodynamic parameters: SVRI and C.I. microcirculation oxidative stress tissue/organ perfusion clinical endpoints (duration of mechanical ventilation, length of stay, mortality).
- Main changes (audit trail)
- RECORD30-jan-2014 - 4-nov-2015


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