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L-carnitine as an Adjunct Treatment for Septic Shock Patients With Acute Kidney Injury

NCT02664753 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2025-08-26

No results posted yet for this study

Summary

The primary objective of this study is to compare 28 day mortality rates between septic shock patients with acute renal insufficiency treated via L-Carnitine (as an adjunct therapy) versus a similar group of patients not receiving L-Carnitine adjunct therapy.

Conditions

Interventions

DRUG

56 days of weight-adjusted L-Carnitine treatment

Patients in the experimental arm will receive 10 days of intravenous L-carnitine treatment followed by 46 days of oral L-Carnitine treatment. Day 1: a first bolus of 6g of L-Carnitine is administered with a syringe driver of 50 ml. Day 2 to Day 10: Two mini-perfusions are prepared each day, corresponding to 1 administration every 12 hours. 50 mg/kg/day (rounded up to the next gram) L-Carnitine is added to each syringes For the next 46 days, patients will take oral doses of L-Carnitine as follows: \< à 60kg : 2g/day \> 60kg : 3g/day If the patient leaves the hospital before D10, oral treatment can be initiated at the end of the hospitalization

DRUG

10 days of intravenous placebo (isotonic saline)

Patients in the placebo arm will receive 10 days of intravenous isotonic saline in a fashion analogous to the experimental arm (they study is thus blinded for the first 10 days and then open there afterwards). Day 1: 1 50ml syringe driver of 50 ml isotonic saline solution . Day 2 to Day 10 : Two syringe drivers of 50 ml of isotonic saline solution are prepared each day, one during the morning and one during the evening.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Principal Investigators

  • Pascal Reboul, MD · Centre Hospitalier Universitaire de Nîmes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-05
Primary Completion
2024-12-04
Completion
2024-12-04

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02664753 on ClinicalTrials.gov