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Does high-dose vitamin B3 supplementation prevent major adverse kidney events during septic shock? A multicenter randomized controlled study.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517055-13-00
Acronym
PI2020_843_0027
Enrollment
310
Registered
2024-09-13
Start date
Unknown
Completion date
2025-09-11
Last updated
2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adverse kidney events during septic shock

Brief summary

the proportion of patients meeting one or more criteria for MAKE30: inhospital 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

Detailed description

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)., Length of hospital stay: defined as the time between admission date of admission and discharge for subjects discharged alive from the resuscitation, 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-glutamyltransferase), nausea, vomiting, headache, flushing, facial erythema, Evaluate the effectiveness of Nicotinamide supplementation according to the urinary quinolonate/ tryptophan ratio on D0 and D1

Interventions

DRUGVITAMINE PP AGUETTANT 500 mg/5 ml
DRUGsolution injectable
DRUGCHLORURE DE SODIUM 0
DRUGsolution pour perfusion
DRUG9 %

Sponsors

Centre Hospitalier Universitaire Amiens Picardie
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
the proportion of patients meeting one or more criteria for MAKE30: inhospital 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

Secondary

MeasureTime frame
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)., Length of hospital stay: defined as the time between admission date of admission and discharge for subjects discharged alive from the resuscitation, 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-glutamyltransferase), nausea, vomiting, headache, flushing, facial erythema, Evaluate the effectiveness of Nicotinamide supplementation according to the urinary quinolonate/ tryptophan ratio on D0 and D1

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026