Does high-dose vitamin B3 supplementation prevent major adverse kidney events during septic shock? A multicenter randomized controlled study.
- Conditions
- adverse kidney events during septic shockTherapeutic area: Not possible to specify
- Registration Number
- EUCTR2020-001276-15-FR
- Lead Sponsor
- CHU Amiens-Picardie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 310
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method