Shorter Recovery Time After Critical Illness

简要总结

详细描述

盲法说明

主要结局

次要结局

• Time to normalization of urine production(Up to 90 days)
• Days on respiratory support(Up to 90 days)
• Days from inclusion to first antibiotic free day(Up to 90 days)
• Change in Katz activities of daily living(14 days prior to admission, baseline, 90 days and 65 weeks)
• Change in forward and backward recall(Day 7, 90 and at 65 weeks)
• Change in NEWS score from -4 hours to 0 hours before first tablet to 1,3, 7 days after first capsule(Four hours before the first administration of NR, at administration of the first capsule and 1, 3 an 7 days after administration of first capsule)
• Change in clinical Frailty Score(Baseline, day 7, day 90 and week 65)
• Time to normalization of blood pressure(Up to 90 days)
• Change in blood pressure during the study period(Baseline and 90 days and 65 weeks)
• Number of days with temperature above 38 at any point from inclusion to discharge.(Up to 90 days)
• Highest CRP from inclusion to end of trial(Up to 90 days)
• Changes in DNA methylation clocks(At baseline, 90 days and 65 weeks.)
• Trail Making Test A(Day 7, 90 and at 65 weeks)
• Change in left ventricular ejection fraction(Baseline, day 7 and at 90 days)
• Change in MoCA(Day 7, 90 and at 65 weeks)
• Mortality(At 90 days, 65 weeks and 10 years)
• Length of stay from randomization to medically fit for discharge from hospital to home or to an institution with a lower care level than a hospital for instance a long term care facility.(Up to 90 days)
• Number of days with temperature above 38 at any point from inclusion to discharge divided on number of days from inclusion to discharge(90 days)
• Number of newly diagnosed infections with identified agent from inclusion to end of trial(90 days and 65 weeks)
• Number of newly diagnosed infections from inclusion to end of trial(90 days and 65 weeks)
• Days on antibiotics from inclusion to end of trial(90 days and 65 weeks)
• Changes in DNA methylation measured by the Illumina DNA methylation BeadArray(At baseline, 90 days and 65 weeks.)
• Change in CAM-ICU(Baseline and day 1,3,7, and every week of hospitalization in ICU)
• Mitochondrial biogenesis - Respiratory Chain Enzyme Analysis(Baseline and 90 days)
• Number of readmissions to hospital(Up to 90 days)
• Change in 4 meter walking test(Baseline, day 7, day 90 and week 65)
• Duration of stay in ICU after randomization(Up to 90 days)
• Change in quality of life(14 days prior to admission, baseline, 90 days and 65 weeks)
• Trail Making Test B(Day 7, 90 and at 65 weeks)
• Change in grip strength over three months(Baseline, day 7, day 90 and at 65 weeks)
• Safety - adverse events(Up to 90 days)
• Changes in hearing(At baseline, 7 and 90 days and 65 weeks)
• Change in mitochondrial biogenesis - mitochondrial DNA quantification(Baseline to 90 days)
• Change in NAD+ (nicotinamide adenosine dinucleotide) and related metabolite blood levels(Baseline, day 7 and day 90)
• Change in ECOG status(14 days prior to admission, baseline, day 7, day 90 and week 65)
• Change in GSC(Day 1, 3 and 7)
• Safety - change in blood analytes(Up to 90 days)