Does High-dose Vitamin B3 Supplementation Prevent Major Adverse Kidney Events During Septic Shock?

Launched by CENTRE HOSPITALIER UNIVERSITAIRE, AMIENS · Oct 14, 2020

Keywords

ClinConnect Summary

This clinical trial is studying whether high doses of Vitamin B3, also known as Nicotinamide, can help prevent serious kidney problems in patients experiencing septic shock. Septic shock is a life-threatening condition where an infection leads to dangerously low blood pressure and can cause acute kidney injury, which is when the kidneys suddenly stop working properly. The researchers aim to find out if giving Nicotinamide can reduce major kidney-related issues by 15% in patients compared to those who receive a placebo (a harmless substance with no active ingredients).

To participate in the trial, patients must be adults diagnosed with septic shock, meaning they have low blood pressure and high levels of lactate in their blood, even after receiving fluids. However, certain patients are not eligible, such as those who need immediate dialysis, have severe chronic kidney disease, or are expected to survive less than 30 days. If eligible and willing to join, participants will receive either Nicotinamide or a placebo and will be monitored closely to see how their kidneys respond over 30 days. This trial is important because it explores a potential new way to protect kidney function in critically ill patients, which could improve their overall outcomes.

Gender

ALL

Eligibility 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.
• • Written informed consent
• 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
• • Pregnant or lactating
• • Legal tutorship and guardianship
• • Lack of social security coverage.