high /medium risk cardiac surgery, acute renal failure
Conditions
Brief summary
The primary endpoint is a composite of the occurrence within 7 days of surgery of one of the following 3 events: - Acute renal failure (ARF). - Occurrence of a postoperative pulmonary complication (PPC). - Use of noradrenaline.
Detailed description
Major cardiac events (MCE), Stroke will be defined by the sudden onset of neurological deficit and confirmed by brain imaging., The total quantity of noradrenaline will be expressed in mg and will correspond to the dose received from admission to intensive care until day 7 after surgery., The side-effects of interest are as follows: Hypernatremia defined by a natraemia > 145 mmol/l. Hyperglycemia defined by the need for insulin therapy. One of the following infections: urinary tract infection, postoperative pneumonitis, mediastinitis., Mortality at 28 days is defined as death from any cause from the date of surgery up to and including day 28.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is a composite of the occurrence within 7 days of surgery of one of the following 3 events: - Acute renal failure (ARF). - Occurrence of a postoperative pulmonary complication (PPC). - Use of noradrenaline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Major cardiac events (MCE), Stroke will be defined by the sudden onset of neurological deficit and confirmed by brain imaging., The total quantity of noradrenaline will be expressed in mg and will correspond to the dose received from admission to intensive care until day 7 after surgery., The side-effects of interest are as follows: Hypernatremia defined by a natraemia > 145 mmol/l. Hyperglycemia defined by the need for insulin therapy. One of the following infections: urinary tract infection, postoperative pneumonitis, mediastinitis., Mortality at 28 days is defined as death from any cause from the date of surgery up to and including day 28. | — |
Countries
France