adverse kidney events during septic shock
Conditions
Interventions
Trade Name: VITAMINE PP AGUETTANT 500 mg/5 mL, solution injectable
Product Name: Nicotinamide 500 mg
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for inject
Sponsors
CHU Amiens-Picardie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients with septic shock defined as sepsis with persisting hypotension requiring vasopressors to maintain MAP =65 mm Hg and having a serum lactate level >2 mmol/L (18 mg/dL) despite adequate volume resuscitation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 210 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: Presence of inclusion criteria for more than 24 hours Immediate indication to start renal replacement therapy at the time of randomization: Hyperkalemia= 6.5 mmol /l, metabolic acidosis with pH <7.15 not controlled by medical treatment, diuretic resistant acute pulmonary edema or accumulation of a toxic requiring dialysis. Formal indication of Nicotinamide supplementation according to the attending physician (eg pellagra, undernutrition, severe alcoholism) Known severe chronic kidney disease (clearance <30 ml /min) in the last 3 months preceding the setic shock or kidney transplant recipient. Moribund patient (estimated survival less than 24 hours) Patient who are not expected to survive to day 30 due to terminal-stage disease (terminal respiratory or heart failure, Child C cirrhosis, uncontrolled cancer) Resuscitated cardiac arrest
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to show the superiority of Nicotinamide supplementation compared to the placebo group, in patients with septic shock admitted to intensive care;Secondary Objective: - Increase in the number of days living without extra-renal treatment on day 30. - Reduction in the incidence of major renal adverse events at day 90 (MAKE 90). - Reducing the length of hospital stay in intensive care. - The good tolerance of Nicotinamide to the doses used in the study. - Evaluation of the efficacy of Nicotinamide supplementation as a function of the urinary quinolonate/ tryptophan ratio on day 0 and day 1 ;Primary end point(s): the proportion of patients meeting one or more criteria for MAKE30: in-hospital mortality, receipt of new RRT, or persistent renal dysfunction defined as a final inpatient serum creatinine value =2 time baseline serum creatinine on day 30;Timepoint(s) of evaluation of this end point: day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The reduction in the incidence of moderate to severe AKI defined as stage 2 and 3 of the KDIGO 2012 classification. - The increase in the number of days living without renal replacement therapy (censored at death or at day 30). - Reduction of the incidence of major renal adverse events at J90 (MAKE 90).The reduction of the intensive care unit length of stay. - liver toxicity, checked on day 1, Day2, day 3 and day 7 (transaminases, bilirubin, alkaline phosphatase, gamma-glutamyl-transferase), nausea, vomiting, headache, flushing, facial erythema. - Evaluate the effectiveness of Nicotinamide supplementation according to the urinary quinolonate/ tryptophan ratio on D0 and D1. ;Timepoint(s) of evaluation of this end point: day 0, 1, 2, 3, 7, 30 and day 90 | — |
Countries
France
Contacts
Public ContactClinical Project Manager
CHU Amiens-Picardie
Outcome results
None listed